Omeprazole

Omeprazole Manufacturers

• Proficient Rx Lp
  

  ×

  Omeprazole | Proficient Rx Lp

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsule is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsule 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsule 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsule 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsule 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsule USP in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsule for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight

  Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

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• Sandoz Inc
  

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  Omeprazole | Sandoz Inc

  

  ---

  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [seeDOSAGE AND ADMINISTRATION(2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules, USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [seeDOSAGE AND ADMINISTRATION (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Cardinal Health
  

  ×

  Omeprazole | Cardinal Health

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

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• Rite Aid Corporation
  

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  Omeprazole | Rite Aid Corporation

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Proficient Rx Lp
  

  ×

  Omeprazole | Proficient Rx Lp

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Meijer Distribution Inc
  

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  Omeprazole | Meijer Distribution Inc

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• H E B
  

  ×

  Omeprazole | H E B

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Walgreen Company
  

  ×

  Omeprazole | Walgreen Company

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  •for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  •swallow 1 tablet with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 tablet a day•do not use for more than 14 days unless directed by your doctor •swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  •you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor •children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

   

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• Northwind Pharmaceuticals, Llc
  

  ×

  Omeprazole | Northwind Pharmaceuticals, Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight          Omeprazole Daily Dose

  10<20kg                                   10 mg

  >20 kg                                      20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Blenheim Pharmacal, Inc.
  

  ×

  Omeprazole | Blenheim Pharmacal, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg, plus clarithromycin 500 mg, plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)] .

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight

  Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Blenheim Pharmacal, Inc.
  

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  Omeprazole | Cvs Pharmacy

  

  ---

  adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor

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• Midwest Drug Distribution, Inc.
  

  ×

  Omeprazole | Kosan Kozmetik Sanayi Ve Ticaret A.s.

  

  ---

  Apply on the center of the lips and blend Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

                    • Limit time in the sun, especially from 10 a.m. - 2 p.m.

                    • Wear long-sleeved shirts, pants, hats and sunglasses.

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• Golden State Medical Supply, Inc
  

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  Omeprazole | Golden State Medical Supply, Inc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Remedyrepack Inc.
  

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  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

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• Rxchange Co.
  

  ×

  Omeprazole | Rxchange Co.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Glenmark Generics Inc., Usa
  

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  Omeprazole | Conair Corporation

  

  ---

  Adult use only: Shake well. Apply to affected area not more than 3-4 times daily.
  

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• Kaiser Foundation Hospitals
  

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  Omeprazole | Kaiser Foundation Hospitals

  

  ---

  Omeprazole delayed-release capsules USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules USP.

  Patients should be informed that the omeprazole delayed-release capsules USP should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole delayed-release capsules USP /clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules USP 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules USP 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole delayed-release capsules USP /clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules USP 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules USP 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules USP in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules USP for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients- 1 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 5 < 10 kg 5 mg 10 < 20 kg 10 mg > 20 kg 20 mg
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule USP.

  For patients who have difficulty swallowing capsules, the contents of a omeprazole delayed-release capsules USP can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Rebel Distributors Corp.
  

  ×

  Omeprazole | Rebel Distributors Corp.

  

  ---

  Omeprazole Delayed-Release Capsule should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration  (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)— The recommended adult oral regimen is omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  Dual Therapy (omeprazole/clarithromycin)— The recommended adult oral regimen is omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration  (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of a Omeprazole Delayed-Release Capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Contract Pharmacy Services-pa
  

  ×

  Omeprazole | Contract Pharmacy Services-pa

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage andAdministration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)— The recommended adult oral regimen is omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosageand Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Altura Pharmaceuticals, Inc.
  

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  Omeprazole | Altura Pharmaceuticals, Inc.

  

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  Omeprazole Delayed-Release Capsule should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration  (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)— The recommended adult oral regimen is omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  Dual Therapy (omeprazole/clarithromycin)— The recommended adult oral regimen is omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration  (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of a Omeprazole Delayed-Release Capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Dexcel Ltd.
  

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  Omeprazole | Dexcel Ltd.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• State Of Florida Doh Central Pharmacy
  

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  Omeprazole | State Of Florida Doh Central Pharmacy

  

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  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Physicians Total Care, Inc.
  

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  Omeprazole | Physicians Total Care, Inc.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Major Pharmaceuticals
  

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  Omeprazole | Bluepoint Laboratories

  

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  Carbidopa and levodopa extended-release tablets contain carbidopa and levodopa in a 1:4 ratio as either the 50 mg/200 mg tablet or the 25 mg/100 mg tablet. The daily dosage of carbidopa and levodopa extended-release must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. Carbidopa and levodopa extended-release tablets should not be chewed or crushed.

  Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa extended-release is being administered, although their dosage may have to be adjusted.

  Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, carbidopa and levodopa extended-release can be given to patients receiving supplemental pyridoxine (vitamin B6).

  Initial Dosage

  Patients currently treated with conventional carbidopa levodopa preparations: Studies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater. Because the bioavailabilities of carbidopa and levodopa in carbidopa and levodopa and carbidopa and levodopa extended-release are different, appropriate adjustments should be made, as shown in Table 2.

  Table 2: Approximate Bioavailabilities at Steady State† Tablet Amount of
  Levodopa (mg)
  in Each Tablet Approximate
  Bioavailability Approximate Amount
  of Bioavailable
  Levodopa (mg) in
  Each Tablet †   This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa. ††  The extent of availability of levodopa from carbidopa and levodopa extended-release tablets was about 70-75% relative to intravenous levodopa or standard carbidopa and levodopa extended-release tablets in the elderly. †††The extent of availability of levodopa from carbidopa and levodopa was 99% relative to intravenous levodopa in the healthy elderly.

  Carbidopa and Levodopa Extended-release
  50 mg/200 mg

  
  200

  
  0.70 to 0.75††

  
  140 to 150

  Carbidopa and Levodopa 25 mg/100 mg

  
  100

  
  0.99†††

  
  99

  Dosage with carbidopa and levodopa extended-release should be substituted at an amount that provides approximately 10% more levodopa per day, although this may need to be increased to a dosage that provides up to 30% more levodopa per day depending on clinical response (see DOSAGE AND ADMINISTRATION, Titration with carbidopa and levodopa extended-release). The interval between doses of carbidopa and levodopa extended-release should be 4 to 8 hours during the waking day. (See CLINICAL PHARMACOLOGY: Pharmacodynamics.)

  A guideline for initiation of carbidopa and levodopa extended-release is shown in Table 3.

  Table 3: Guidelines for Initial Conversion from Carbidopa and Levodopa to Carbidopa and Levodopa Extended-Release *For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION: Initial Dosage — Patients currently treated with conventional carbidopa-levodopa preparations.

  Carbidopa and Levodopa
  Total Daily Dose*
  Levodopa (mg)

  Carbidopa and Levodopa Extended-Release
  Suggested
  Dosage Regimen

  300 to 400

  200 mg b.i.d.

  500 to 600

  300 mg b.i.d. or 200 mg t.i.d.

  700 to 800

  A total of 800 mg in 3 or more divided doses (e.g., 300 mg a.m., 300 mg early p.m., and 200 mg later p.m.)

  900 to 1000

  A total of 1000 mg in 3 or more divided doses (e.g., 400 mg a.m., 400 mg early p.m., and 200 mg later p.m.)

  Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with carbidopa and levodopa extended-release is started. Carbidopa and levodopa extended-release should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of 50 mg/200 mg carbidopa and levodopa extended-release tablets b.i.d.

  Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of 50 mg/200 mg carbidopa and levodopa extended-release tablets b.i.d. Initial dosage should not be given at intervals of less than 6 hours.

  Titration with Carbidopa and Levodopa Extended-release

  Following initiation of therapy, doses and dosing intervals may be increased or decreased depending upon therapeutic response. Most patients have been adequately treated with doses of carbidopa and levodopa extended-release that provide 400 to 1600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of carbidopa and levodopa extended-release (2400 mg or more of levodopa per day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended.

  When doses of carbidopa and levodopa extended-release are given at intervals of less than 4 hours, and/or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day.

  An interval of at least 3 days between dosage adjustments is recommended.

  Maintenance

  Because Parkinson's disease is progressive, periodic clinical evaluations are recommended; adjustment of the dosage regimen of carbidopa and levodopa extended-release may be required.

  Addition of Other Antiparkinson Medications

  Anticholinergic agents, dopamine agonists, and amantadine can be given with carbidopa and levodopa extended-release. Dosage adjustment of carbidopa and levodopa extended-release may be necessary when these agents are added.

  A dose of carbidopa and levodopa immediate release 25 mg/100 mg or 10 mg/100 mg (one half or a whole tablet) can be added to the dosage regimen of carbidopa and levodopa extended-release in selected patients with advanced disease who need additional immediate-release levodopa for a brief time during daytime hours.

  Interruption of Therapy

  Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa and levodopa or carbidopa and levodopa extended-release.

  Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa extended-release is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, carbidopa and levodopa extended-release may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual dosage should be administered as soon as the patient is able to take oral medication.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Omeprazole | Lake Erie Medical Dba Quality Care Products Llc

  

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  2 DOSAGE AND ADMINISTRATION

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
  

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
  

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
  

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
  

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  
  
  
  
  
  
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Rebel Distributors Corp
  

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  Omeprazole | Rebel Distributors Corp

  

  ---

  2 DOSAGE AND ADMINISTRATION

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2

  H. pylori

  Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
  

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
  

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
  

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
  

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  
  
  
  
  
  
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  16 HOW SUPPLIED/STORAGE AND HANDLING

  Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘0el’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink.

  Bottles of 30                                                                  NDC 21695-617-30        

  Bottles of 90                                                                NDC 21695-617-90        

  17 PATIENT COUNSELING INFORMATION

  Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Physicians Total Care, Inc.
  

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  Omeprazole | Physicians Total Care, Inc.

  

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  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Dexcel Pharma Technologies Ltd.
  

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  Omeprazole | Dexcel Pharma Technologies Ltd.

  

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  Directions

  adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age:  ask a doctor.  Heartburn in children may sometimes be caused by a serious condition.
  

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• Cardinal Health
  

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  Omeprazole | Cardinal Health

  

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  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See DOSAGE AND ADMINISTRATION (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules, USP are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 5 < 10 kg 5 mg 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see DOSAGE AND ADMINISTRATION (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of a omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Kaiser Foundation Hospitals
  

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  Omeprazole | Kaiser Foundation Hospitals

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies ( 14.4 )].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration ( 2.8 )].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3) ].

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Omeprazole | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  2 DOSAGE AND ADMINISTRATION

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
  

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
  

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
  

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
  

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  
  
  
  
  
  
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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  More Info
• Legacy Pharmaceutical Packaging
  

  ×

  Omeprazole | Legacy Pharmaceutical Packaging

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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  More Info
• Stat Rx Usa Llc
  

  ×

  Omeprazole | Stat Rx Usa Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
   The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Unit Dose Services
  

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  Omeprazole | Unit Dose Services

  

  ---

  2 DOSAGE AND ADMINISTRATION

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2

  H. pylori

  Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
  

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
  

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
  

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
  

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  
  
  
  
  
  
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  16 HOW SUPPLIED/STORAGE AND HANDLING

  Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘0el’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink.

  Bottles of 30                                                                  NDC 21695-617-30        

  Bottles of 90                                                                NDC 21695-617-90        

  17 PATIENT COUNSELING INFORMATION

  Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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  More Info
• Life Line Home Care Services, Inc.
  

  ×

  Omeprazole | Life Line Home Care Services, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Stat Rx Usa Llc
  

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  Omeprazole | Stat Rx Usa Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Unit Dose Services
  

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  Omeprazole | Unit Dose Services

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [ ]. seeDosage and Administration ( ) 2.8

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence H. pylori

  — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief. Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin)

  — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief. Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin)

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [ ]. seeClinical Studies ( ) 14.4

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [ ]. see Dosage and Administration ( ) 2.8

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see and ]. Warnings and Precautions (5.4)Drug Interactions (7.3)

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• H.j. Harkins Company, Inc.
  

  ×

  Omeprazole | H.j. Harkins Company, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Cardinal Health
  

  ×

  Omeprazole | Cardinal Health

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole release-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

   Patient Weight  Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of a omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Rebel Distributors Corp
  

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  Omeprazole | Rebel Distributors Corp

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Medsource Pharmaceuticals
  

  ×

  Omeprazole | Medsource Pharmaceuticals

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Major Pharmaceuticals
  

  ×

  Omeprazole | Apotheca Company

  

  ---

  Directions: 10 drops orally 3 times a day or as directed by a health care professional.  Consult a physician for use in children under 12 years of age
  

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• Aidarex Pharmaceuticals Llc
  

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  Omeprazole | Aidarex Pharmaceuticals Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Omeprazole | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Bryant Ranch Prepack
  

  ×

  Omeprazole | Bryant Ranch Prepack

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See ]. Dosage and Administration (2.8)

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pyloriEradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See ] Clinical Studies (14.4)

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See ]. Dosage and Administration (2.8)

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see ]. Warnings and Precautions(5.4)and Drug Interactions(7.3)

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• Kroger Company
  

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  Omeprazole | Apexel Co., Ltd

  

  ---

  for oral use only

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• Cadila Healthcare Limited
  

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  Omeprazole | Cadila Healthcare Limited

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see DOSAGE AND ADMINISTRATION (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [see CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight 
  Omeprazole Daily Dose
  10 < 20 kg 
  10 mg
  ≥ 20 kg 
  20 mg
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see DOSAGE AND ADMINISTRATION (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Omeprazole | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) -

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Perrigo New York Inc
  

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  Omeprazole | Dolgencorp, Llc

  

  ---

  adults and children 6 years & older: rinse for 30 secnds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use

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• Rite Aid Corporation
  

  ×

  Omeprazole | Rite Aid Corporation

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

   Patient Weight  Omeprazole Daily Dose  10 < 20 kg  10 mg  > 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological acitivity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

   Patient Weight  Omeprazole Daily Dose  10 < 20 kg  10 mg  > 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological acitivity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Omeprazole | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See DOSAGE AND ADMINISTRATION (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules, USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see DOSAGE AND ADMINISTRATION (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of a omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Hyvee Inc
  

  ×

  Omeprazole | Harmon Stores Inc.

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• H E B
  

  ×

  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Tamsulosin hydrochloride capsules, USP 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day.

  For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules, USP can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules, USP 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].

  If tamsulosin hydrochloride capsules, USP administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

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• Publix Super Markets Inc
  

  ×

  Omeprazole | Publix Super Markets Inc

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition

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• Major Pharmaceuticals
  

  ×

  Omeprazole | Major Pharmaceuticals

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Meijer Distribution Inc
  

  ×

  Omeprazole | Mckesson

  

  ---

  • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • mL = milliliter

  Age

  Dose

  children 6 years to under 12 years

  5 mL - 10 mL every 4 hours

  children 4 years to under 6 years

  2.5 mL – 5 mL every 4 hours

  children under 4 years

  do not use

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
   The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [seeWarnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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• Cvs Pharmacy
  

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  Omeprazole | Apotheca Company

  

  ---

  Directions: 10 drops orally, 3 times a day or as directed by a health care professional,
  

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• Walgreen Company
  

  ×

  Omeprazole | Cintex Services, Llc

  

  ---

  2.1 Recommended Dosage

  Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 4 doses (40 mL) in 24 hours.

  Administer HYCOFENIX by the oral route only. Measure HYCOFENIX with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warning and Precautions (5.10)].

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• Western Family Foods Inc
  

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  Omeprazole | Western Family Foods Inc

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
   The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [seeWarnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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  More Info
• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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• Gericare Pharmaceuticals
  

  ×

  Omeprazole | Gericare Pharmaceuticals

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets  

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor   • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

  Close
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  More Info
• Remedyrepack Inc.
  

  ×

  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
   The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [seeWarnings and Precautions (5.4) and Drug Interactions (7.3)].

   

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  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
   The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with Clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [seeWarnings and Precautions (5.4) and Drug Interactions (7.3)].

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  Close
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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Omeprazole | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

  2.9 Use with clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Remedyrepack Inc.
  

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  Omeprazole | Remedyrepack Inc.

  

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  •for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  •swallow 1 tablet with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 tablet a day•do not use for more than 14 days unless directed by your doctor •swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  •you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor •children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

   

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• Dr. Reddy’s Laboratories Limited
  

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  Omeprazole | Dr. Reddy's Laboratories Limited

  

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  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months. [SeeClinical Studies(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Golden State Medical Supply
  

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  Omeprazole | Golden State Medical Supply

  

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  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Dispensing Solutions, Inc.
  

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  Omeprazole | Dispensing Solutions, Inc.

  

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  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Mylan Institutional Inc.
  

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  Omeprazole | Mylan Institutional Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight

  Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Legacy Pharmaceutical Packaging
  

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  Omeprazole | Legacy Pharmaceutical Packaging

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Omeprazole | Lake Erie Medical Dba Quality Care Products Llc

  

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  NDC:

  2 DOSAGE AND ADMINISTRATION

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See Dosage and Administration (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2

  H. pylori

  Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days ofomeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsules can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  16 HOW SUPPLIED/STORAGE AND HANDLING

  Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘0el’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink.

  
     NDC: 35356-891-60  Bottles of 60

  17 PATIENT COUNSELING INFORMATION

  Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• St Marys Medical Park Pharmacy
  

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  Omeprazole | Target Corporation

  

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  • adults and children 2 years of age or older: • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage • children under 2 years of age: ask a doctor

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• American Pharmaceutical Ingredients Llc
  

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  Omeprazole | American Pharmaceutical Ingredients Llc

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Shopko Stores Operating Co., Llc
  

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  Omeprazole | Cardinal Health

  

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  2.1 Adult Patients

  [See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]

  Infection* Recommended Dose/Duration of Therapy

  Community-acquired pneumonia

  Pharyngitis/tonsillitis (second-line therapy)

  Skin/skin structure (uncomplicated)

  500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5

  Acute bacterial exacerbations of chronic obstructive pulmonary disease

  500 mg once daily for 3 days

  OR

  500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5

  Acute bacterial sinusitis

  500 mg once daily for 3 days

  Genital ulcer disease (chancroid)

  One single 1 gram dose

  Non-gonococcal urethritis and cervicitis

  One single 1 gram dose

  Gonococcal urethritis and cervicitis

  One single 2 gram dose

  *DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]

  Azithromycin tablets can be taken with or without food.

  2.2 Pediatric Patients1 Infection* Recommended Dose/Duration of Therapy

  Acute otitis media

  30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

  Acute bacterial sinusitis

  10 mg/kg once daily for 3 days.

  Community-acquired pneumonia

  10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

  Pharyngitis/tonsillitis

  12 mg/kg once daily for 5 days.

  *DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]

  1see dosing tables below for maximum doses evaluated by indication

  Azithromycin can be taken with or without food.

  PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY‑ACQUIRED PNEUMONIA
  (Age 6 months and above, [see Use in Specific Populations (8.4)])
  Based on Body Weight

  OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5

  5

  11

  2.5 mL; (½ tsp)

  1.25 mL; (¼ tsp)

  7.5 mL

  150 mg

  10

  22

  5 mL; (1 tsp)

  2.5 mL; (½ tsp)

  15 mL

  300 mg

  20

  44

  5 mL; (1 tsp)

  2.5 mL; (½ tsp)

  15 mL

  600 mg

  30

  66

  7.5 mL; (1½ tsp)

  3.75 mL; (¾ tsp)

  22.5 mL

  900 mg

  40

  88

  10 mL; (2 tsp)

  5 mL; (1 tsp)

  30 mL

  1200 mg

  50 and above

  110 and above

  12.5 mL; (2½ tsp)

  6.25 mL; (1¼ tsp)

  37.5 mL

  1500 mg

  * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

  OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-3

  5

  11

  2.5 mL; (1/2 tsp)

  7.5 mL

  150 mg

  10

  22

  5 mL; (1 tsp)

  15 mL

  300 mg

  20

  44

  5 mL (1 tsp)

  15 mL

  600 mg

  30

  66

  7.5 mL (1½ tsp)

  22.5 mL

  900 mg

  40

  88

  10 mL (2 tsp)

  30 mL

  1200 mg

  50 and above

  110 and above

  12.5 mL (2 ½ tsp)

  37.5 mL

  1500 mg

  *Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.

  OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen

  5

  11

  3.75 mL;(3/4 tsp)

  3.75 mL

  150 mg

  10

  22

  7.5 mL;(1½ tsp)

  7.5 mL

  300 mg

  20

  44

  15 mL;(3 tsp)

  15 mL

  600 mg

  30

  66

  22.5 mL;(4½ tsp)

  22.5 mL

  900 mg

  40

  88

  30 mL;(6 tsp)

  30 mL

  1200 mg

  50 and above

  110 and above

  37.5 mL;(7½ tsp)

  37.5 mL

  1500 mg

  The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

  Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

  PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
  (Age 2 years and above, [see Use in Specific Populations (8.4)])
  Based on Body Weight

  PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per
  Treatment Course Total mg per
  Treatment Course Kg Lbs. Day 1-5

  8

  18

  2.5 mL; (½ tsp)

  12.5 mL

  500 mg

  17

  37

  5 mL; (1 tsp)

  25 mL

  1000 mg

  25

  55

  7.5 mL; (1½ tsp)

  37.5 mL

  1500 mg

  33

  73

  10 mL; (2 tsp)

  50 mL

  2000 mg

  40

  88

  12.5 mL; (2½ tsp)

  62.5 mL

  2500 mg

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• Remedyrepack Inc.
  

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  Omeprazole | Remedyrepack Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

   

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

   

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

   

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

   

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

   

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

   

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

   

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

   

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

   

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• Safeway
  

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  Omeprazole | Safeway

  

  ---

  • adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Watson Pharma, Inc.
  

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  Omeprazole | Actavis Pharma, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

   Patient Weight  Omeprazole Daily Dose      10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Preferred Pharmaceuticals, Inc.
  

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  Omeprazole | Preferred Pharmaceuticals, Inc.

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Clinical Solutions Wholesale
  

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  Omeprazole | Clinical Solutions Wholesale

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and AdministrationC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - williamsonbk1196705239379(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [SeeC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - williamsonbk1196694240761Clinical StudiesC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - Erosive-Esophagitis(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• New Horizon Rx Group, Llc
  

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  Omeprazole | New Horizon Rx Group, Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)
  

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)
  

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Aidarex Pharmaceuticals Llc
  

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  Omeprazole | Aidarex Pharmaceuticals Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [SeeClinical Studies(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• American Health Packaging
  

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  Omeprazole | Baxter Healthcare Corporation

  

  ---

  Treatment of Anaerobic Bacterial Infections

  The recommended dosage schedule for adults is:

  Loading Dose

  15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult).

  Maintenance Dose

  7.5 mg/kg infused over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose.

  Parenteral therapy may be changed to oral metronidazole when conditions warrant, based upon the severity of the disease and the response of the patient to Metronidazole Injection, USP treatment. The usual adult oral dosage is 7.5 mg/kg every six hours (approximately 500 mg for a 7-kg adult).

  A maximum of 4 g should not be exceeded during a 24-hour period.

  The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract and endocardium may require longer treatment.

  Dosage Adjustments Patients with Severe Hepatic Impairment

  For patients with severe hepatic impairment (Child-Pugh C), the metronidazole dose should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

  Patients Undergoing Hemodialysis

  Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from a hemodialysis session, supplementation of metronidazole dosage following a hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).

  Prophylaxis

  For surgical prophylactic use, to prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended dosage schedule for adults is:

  a. 15 mg/kg infused over 30 to 60 minutes and completed approximately one hour before surgery; followed by b. 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose.

  It is important that (1) administration of the initial preoperative dose be completed approximately one hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and (2) Metronidazole Injection, USP be administered, if necessary, at 6-hour intervals to maintain effective drug levels. Prophylactic use of Metronidazole Injection, USP should be limited to the day of surgery only, following the above guidelines.

  Caution: Metronidazole Injection, USP is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. Additives should not be introduced into Metronidazole Injection, USP. If used with a primary intravenous fluid system, the primary solution should be discontinued during metronidazole infusion. DO NOT USE EQUIPMENT CONTAINING ALUMINUM (e.g., NEEDLES, CANNULAE) THAT WOULD COME IN CONTACT WITH THE DRUG SOLUTION.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Preferred Pharmaceuticals, Inc.
  

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  Omeprazole | Chattem, Inc.

  

  ---

  adults and children over 12 years:

  apply generously to affected area
  massage into painful area until thoroughly absorbed into skin
  repeat as necessary, but no more than 3 to 4 times daily

  children 12 years and younger: ask a doctor

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• Dr. Reddy’s Laboratories Limited
  

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  Omeprazole | Cardinal Health

  

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  Citalopram tablets should be administered once daily, in the morning or evening, with or without food.

  Initial Treatment

  Citalopram tablets (citalopram HBr) should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day. Dose increase should usually occur in increments of 20 mg at intervals of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

  Special Populations

  20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients. 20 mg/day is the maximum recommended dose for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor.

  No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.

  Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram in the third trimester.

  Maintenance Treatment

  It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

  Discontinuation of Treatment with Citalopram

  Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Switching Patients To or From a Monoamine Oxidase Inhibitor

  At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram therapy. Similarly, at least 14 days should be allowed after stopping citalopram before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

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• Mckesson Packaging Services A Business Unit Of Mckesson Corporation
  

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  Omeprazole | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Unit Dose Services
  

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  Omeprazole | Unit Dose Services

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [ ]. See Dosage and Administration (2.8)

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence H. pylori

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief. Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief. Dual Therapy (omeprazole/clarithromycin) 
  

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [ ] See Clinical Studies (14.4)

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [ ]. See Dosage and Administration (2.8)

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Zydus Pharmaceuticals (Usa) Inc.
  

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  Omeprazole | Allergan, Inc.

  

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  Instill one drop in each eye once daily. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

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• Mckesson Contract Packaging
  

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  Omeprazole | Mckesson Contract Packaging

  

  ---

  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available. [See DOSAGE AND ADMINISTRATION (2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules,USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [See CLINICAL STUDIES (14.4) ]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See DOSAGE AND ADMINISTRATION (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Aphena Pharma Solutions – Tennessee, Llc
  

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  Omeprazole | Aphena Pharma Solutions - Tennessee, Llc

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Sandoz Inc
  

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  Omeprazole | Sandoz Inc

  

  ---

  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [seeDOSAGE AND ADMINISTRATION(2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules, USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [seeDOSAGE AND ADMINISTRATION (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Aphena Pharma Solutions – Tennessee, Llc
  

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  Omeprazole | Aphena Pharma Solutions - Tennessee, Llc

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Apotex Corp
  

  ×

  Omeprazole | Apotex Corp

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Kremers Urban Pharmaceuticals Inc.
  

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  Omeprazole | Kremers Urban Pharmaceuticals Inc.

  

  ---

  Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.

  Patients should be informed that the Omeprazole Delayed-Release Capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  10 < 20 kg  10 mg  ≥ 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole Delayed-Release Capsule is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.

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• Cardinal Health
  

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  Omeprazole | Cvs Pharmacy

  

  ---

  Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

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• Proficient Rx Lp
  

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  Omeprazole | Bowyn Labs, Llc

  

  ---

  Apply to affected area(s) three to four times per day or as directed by a physician.

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• American Health Packaging
  

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  Omeprazole | Covalence, Inc.

  

  ---

  Directions:

  
  Adults and children 12 years of age or older: Apply to the affected are no more than 3 to 4 times daily.

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• Readymeds
  

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  Omeprazole | Readymeds

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [see Clinical Studies (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:

   Patient Weight  Omeprazole Daily Dose  5< 10 kg  5 mg  10 < 20 kg  10 mg  > 20 kg  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Avpak
  

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  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

  In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.

  The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

  When used in streptococcal infections, therapy should be continued for 10 days.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (See ADVERSE REACTIONS).

  If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

  Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.

  Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

  Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for 7 days.

  Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg, by mouth, twice a day for 7 days.

  Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.

  Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.

  Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

  Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

  For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

  Inhalational anthrax (post-exposure):
  ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
  CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

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• Bryant Ranch Prepack
  

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  Omeprazole | Bryant Ranch Prepack

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with Clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Cardinal Health
  

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  Omeprazole | Cardinal Health

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

  Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin)

  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg 3 times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight

  Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole delayed-release capsules required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  2.9 Use with Clopidogrel

  Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.4) and Drug Interactions (7.3)].

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• Cardinal Health
  

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  Omeprazole | Cardinal Health

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and AdministrationC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - williamsonbk1196705239379(2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. [SeeC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - williamsonbk1196694240761Clinical StudiesC:Documents and Settingsp00019458Desktopd78b53a1-b20c-bf2f-6d08-3af72bbec957.xml - Erosive-Esophagitis(14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Mylan Pharmaceuticals Inc.
  

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  Omeprazole | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Adults

  The usual oral dose of terbutaline sulfate for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg.

  Children

  Terbutaline sulfate is not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12 to 15 years of age. The total dose within 24 hours should not exceed 7.5 mg.

  If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.

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• Safecor Health, Llc
  

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  Omeprazole | Safecor Health, Llc

  

  ---

  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole. 

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole. 

  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) 
  The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose

  10 < 20 kg

  10 mg

  ≥ 20 kg

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule. 

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.

  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Aurobindo Pharma Limited
  

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  Omeprazole | Aurobindo Pharma Limited

  

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  Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
  
  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
  
  For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin)— The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
  
  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer
  

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)
  

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis
  

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

  2.7 Pediatric Patients
  

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose 10 < 20 kg
  10 mg
  ≥ 20 kg
  20 mg
  
  

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
  
  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.
  
  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.
  
  One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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• Cvs Pharmacy
  

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  Omeprazole | Cvs Pharmacy

  

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  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Omeprazole | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  Omeprazole delayed-release capsules, USP should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

  Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

  For patients unable to swallow an intact capsule, alternative administration options are available [seeDOSAGE AND ADMINISTRATION(2.8)]

  2.1 Short-Term Treatment of Active Duodenal Ulcer

  The recommended adult oral dose of omeprazole delayed-release capsules, USP is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

  Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  2.3 Gastric Ulcer

  The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.

  2.4 Gastroesophageal Reflux Disease (GERD)

  The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

  2.5 Maintenance of Healing of Erosive Esophagitis

  The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see CLINICAL STUDIES (14.4)]

  2.6 Pathological Hypersecretory Conditions

  The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole for more than 5 years.

  2.7 Pediatric Patients

  For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:

  Patient Weight Omeprazole Daily Dose  

  10 < 20 kg

   

  10 mg

   

  ≥ 20 kg

   

  20 mg

  On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

  Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [seeDOSAGE AND ADMINISTRATION (2.8) ].

  2.8 Alternative Administration Options

  Omeprazole is available as a delayed-release capsule.

  For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

  Close
  No Recall

  More Info