RANITIDINE - ranitidine hydrochloride solution
Amneal Pharmaceuticals
Rx Only
DESCRIPTION
The active ingredient in Ranitidine Oral Solution 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
he empirical formula is C13 H22 N4 O3 S�HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.
Each 1 mL of Ranitidine Oral Solution contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Oral Solution also contains the inactive ingredients butylparaben, dibasic sodium phosphate, hypromellose, monobasic sodium phosphate, natural peppermint extract, propylene glycol, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol solution.
CLINICAL PHARMACOLOGY
Ranitidine hydrochloride is a competitive, reversible inhibitor of the action of histamine at the histamine H2 -receptors, including receptors on the gastric cells. Ranitidine hydrochloride does not lower serum Ca++ in hypercalcemic states. Ranitidine hydrochloride is not an anticholinergic agent.
INDICATIONS & USAGE
Ranitidine Oral Solution 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 Oral Solution 150 mg b.i.d.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Oral Solution 150 mg q.i.d.
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.
