Ranitidine Syrup
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Ranitidine oral solution USP is indicated in:
- Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
- The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
- Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
- Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
- Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
- Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
- Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution, USP) is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N′-methyl-2-nitro-1,1- ethenediamine, HCl. It has the following structure:
The empirical formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow crystalline powder that is very soluble in water and sparingly soluble in alcohol.
Each mL of Ranitidine oral solution USP contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine oral solution USP also contains the inactive ingredients 7.5% alcohol, butylparaben, dibasic sodium phosphate, hypromellose, monobasic potassium phosphate, natural & artificial mint flavor, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol solution.
Sources
Ranitidine Syrup Manufacturers
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Dr. Reddy’s Laboratories Limited
![Ranitidine Syrup [Dr. Reddy’s Laboratories Limited]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ranitidine Syrup | Dr. Reddy's Laboratories Limited
Active Duodenal UlcerThe current recommended adult oral dosage of ranitidine oral solution USP for duodenal ulcer is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of oral solution (4 teaspoonfuls of oral solution equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal UlcersThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome)The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice a day. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
Benign Gastric UlcerThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Maintenance of Healing of Gastric UlcersThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
GERDThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Erosive EsophagitisThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) 4 times daily.
Maintenance of Healing of Erosive EsophagitisThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Pediatric UseThe safety and effectiveness of ranitidine oral solution USP have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine oral solution USP in neonatal patients (less than 1 month of age) to make dosing recommendations.
The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric UlcersThe recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric UlcersThe recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive EsophagitisAlthough limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.
Dosage Adjustment for Patients With Impaired Renal FunctionOn the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine oral solution USP, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICALPHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
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Caraco Pharmaceutical Laboratories, Ltd.
Ranitidine Syrup | Sun Pharmaceutical Industries, Inc.
Active Duodenal Ulcer:The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of oral solution (4 teaspoonfuls of oral solution equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal Ulcers:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
Benign Gastric Ulcer:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Maintenance of Healing of Gastric Ulcers:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
GERD:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Erosive Esophagitis:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) 4 times daily.
Maintenance of Healing of Erosive Esophagitis:The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Pediatric Use:The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (less than 1 month of age) to make dosing recommendations.
The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.
Dosage Adjustment for Patients With Impaired Renal FunctionOn the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance < 50 mL/min is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
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Sandoz Inc.
Ranitidine Syrup | Sandoz Inc.
Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine oral solution, USP for duodenal ulcer is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of oral solution (4 teaspoonfuls of oral solution equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):
The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. In some patients it may be necessary to administer ranitidine oral solution, USP 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
GERD: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Erosive Esophagitis: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) 4 times daily.
Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Pediatric Use: The safety and effectiveness of ranitidine oral solution, USP have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine oral solution, USP in neonatal patients (less than 1 month of age) to make dosing recommendations.
The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.
Dosage Adjustment for Patients With Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine oral solution, USP, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
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Heritage Pharmaceuticals Inc.
Ranitidine Syrup | Heritage Pharmaceuticals Inc.
Active Duodenal UlcerThe current recommended adult oral dosage of ranitidine oral solution USP for duodenal ulcer is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. An alternative dosage of 300 mg or 20 mL of oral solution (4 teaspoonfuls of oral solution equivalent to 300 mg of ranitidine) once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal UlcersThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome)The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice a day. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
Benign Gastric UlcerThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Maintenance of Healing of Gastric UlcersThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime.
GERDThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Erosive EsophagitisThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) 4 times daily.
Maintenance of Healing of Erosive EsophagitisThe current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily.
Pediatric UseThe safety and effectiveness of ranitidine oral solution USP have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine oral solution USP in neonatal patients (less than 1 month of age) to make dosing recommendations.
The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers
The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers
The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis
Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.
Dosage Adjustment for Patients With Impaired Renal FunctionOn the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine oral solution USP, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICALPHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
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