Ranitidine

INDICATIONS & USAGE

Ranitidine Tablets are indicated in:

1. 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.
2. 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.
3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
4. Short-term treatment of active, benign gastric ulcers. 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.
5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily.
7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily.
8. 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.

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DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer: The current recommended adult oral dosage of Ranitidine Tablets for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. 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.
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Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
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Pathological Hypersecretory Conditions (such as Zollinger - Ellison syndrome): The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer Ranitidine Tablets 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.
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Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice daily.
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Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
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GERD: The current recommended adult oral dosage is 150 mg twice daily.
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Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times daily.
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Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.
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Pediatric Use: The safety and effectiveness of Ranitidine Tablets have been established in the age group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Ranitidine Tablets 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 recommendations is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
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Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is to 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.
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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.
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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 Tablets, the recommended dosage in patients with a creatinine clearance < 50 mL/min is 150 mg 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

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CONTRAINDICATIONS

Ranitidine Tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

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Full Prescribing Information: DailyMed

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