DESCRIPTION
id: 415b168c-1224-2777-e054-00144ff88e88
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
The active ingredient in ranitidine tablets USP 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H
2-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 C
13H
22N
4O
3S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor.
Each ranitidine tablet USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin.
Each ranitidine tablet USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin.
CLINICAL PHARMACOLOGY
id: 415b168c-1225-2777-e054-00144ff88e88
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H
2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.
INDICATIONS AND USAGE
id: 415b168c-123c-2777-e054-00144ff88e88
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Ranitidine tablets USP are 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.
CONTRAINDICATIONS
id: 415b168c-123d-2777-e054-00144ff88e88
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see
PRECAUTIONS
).
ADVERSE REACTIONS
id: 415b168c-1248-2777-e054-00144ff88e88
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.
OVERDOSAGE
id: 415b168c-1253-2777-e054-00144ff88e88
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see
ADVERSE REACTIONS
). In addition, abnormalities of gait and hypotension have been reported.
When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD
50 values in mice and rats were 77 and 83 mg/kg, respectively.
HOW SUPPLIED
id: 415b168c-1262-2777-e054-00144ff88e88
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Ranitidine tablets USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with
“G51” engraved on one side and
“150” on the other side. They are available in bottles of 60 (NDC 68462-248-60), 100 (NDC 68462-248-01), and 500 (NDC 68462-248-05) tablets.
Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with
“G51” engraved on one side and
“300” on the other side. They are available in bottles of 30 (NDC 68462-249-30) ,100 (NDC 68462-249-01) and 250 (NDC 68462-249-20) tablets.
