Prilosec

Prilosec Manufacturers

• Stat Rx Usa Llc
  

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  Prilosec | Stat Rx Usa Llc

  

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  2 DOSAGE AND ADMINISTRATION

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

  Patients should be informed that the PRILOSEC 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 PRILOSEC 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 (PRILOSEC/clarithromycin/amoxicillin) — The recommended adult oral regimen is PRILOSEC 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 PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual Therapy (PRILOSEC/clarithromycin) — The recommended adult oral regimen is PRILOSEC 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 PRILOSEC 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 PRILOSEC 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 PRILOSEC 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:

  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

  PRILOSEC is available as a delayed-release capsule or as a delayed-release oral suspension.

  For patients who have difficulty swallowing capsules, the contents of a PRILOSEC 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.

  PRILOSEC For Delayed-Release Oral Suspension should be administered as follows:

  Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.

  Empty the contents of a 10 mg packet into a container containing 15 mL of water.

  Stir

  Leave 2 to 3 minutes to thicken.

  Stir and drink within 30 minutes.

  If any material remains after drinking, add more water, stir and drink immediately.

  For patients with a nasogastric or gastric tube in place:

  Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering PRILOSEC through a nasogastric tube or gastric tube.

  Immediately shake the syringe and leave 2 to 3 minutes to thicken.

  Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.

  Refill the syringe with an equal amount of water.

  Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

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• Astrazeneca Lp
  

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  Prilosec | Bryant Ranch Prepack

  

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  Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Direction for use specific to the route and available methods of administration of this dosage form is presented below. Lansoprazole should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.

  2.1 Recommended Dose

  *Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
  

  † Controlled studies did not extend beyond indicated duration.
  

  ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
  

  §The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
  

  ¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
  

  #Controlled studies did not extend beyond 12 months.
  

  Indication
  Recommended Dose
  Frequency
  Duodenal Ulcers
  
  
  Short-Term Treatment
  15 mg
  Once daily for 4 weeks
  Maintenance of Healed
  15 mg
  Once daily
  H. pylori Eradication to 
  Reduce the Risk of 
  Duodenal Ulcer  Recurrence*
  
  
  Triple Therapy:
  
  
        Lansoprazole  
  30 mg
  Twice daily (q12h) for 10 or 14 days
       Amoxicillin
  1 gram
  Twice daily (q12h) for 10 or 14 days
       Clarithromycin
  500 mg
  Twice daily (q12h) for 10 or 14 days
  Dual Therapy:
  
  
        Lansoprazole  
  30 mg
  Three times daily (q8h) for 14 days
       Amoxicillin
  1 gram
  Three times daily (q8h) for 14 days
  Benign Gastric Ulcer
  
  
       Short-Term Treatment
  30 mg
  Once daily for up to 8 weeks
  NSAID-associated  Gastric Ulcer
  
  
        Healing 
  30 mg
  Once daily for 8 weeks†
        Risk Reduction
  15 mg
  Once daily for up to 12 weeks†
  Gastroesophageal Reflux Disease (GERD)
  
  
     Short-Term Treatment                                                                                                                              of Symptomatic GERD
  15 mg
  Once daily for up to 8 weeks
        Short-Term 
  Treatment of Erosive     Esophagitis
  30 mg
  Once daily for up to 8 weeks‡
  Pediatric
  
  
  (1 to 11 years of age)
  
  
  Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
       ≤ 30 kg
  15 mg
  Once daily for up to 12 weeks§
       > 30 kg
  30 mg
  Once daily for up to 12 weeks§
  (12 to 17 year of age)
  
  
  Short-Term Treatment of Symptomatic GERD
       Nonerosive GERD
  15 mg
  Once daily for  up to 8 weeks
       Erosive Esophagitis
  30 mg
  Once daily for  up to 8 weeks
  Maintenance of Healing of Erosive Esophagitis
  15 mg
  Once daily
  Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome
  60 mg
  Once daily¶
  

  Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

  2.2 Special Populations

  Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see USE IN SPECIFIC POPULATIONS (8.5, 8.6 and 8.7)].

  2.3 Important Administration Information

  Administration Option

  Lansoprazole Delayed-release Capsules – Oral Administration

  Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:

        о   Open capsule.

        о   Sprinkle intact granules on one tablespoon of either applesauce, ENSURE     pudding, cottage cheese, yogurt or strained pears.

        о   Swallow immediately.

  Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:

        о   Open capsule.

        о   Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).

        о   Mix briefly.

        о   Swallow immediately.

        о   To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

  Lansoprazole delayed-release capsules - Nasogastric Tube (≥ 16 French) Administration

  For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:

        о   Open capsule.

        о   Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.

        о   Inject through the nasogastric tube into the stomach.

        о   Flush with additional apple juice to clear the tube.

  USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

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