DESCRIPTION
id: 95012984-2e69-46fd-8355-9fafa0d1aff4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Ranitidine hydrochloride (HCl), is 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, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor.
Each tablet, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D & C Red #30 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide and flavoring. The 300 mg also contains: D & C Yellow #10 Aluminum Lake.
Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.
CLINICAL PHARMACOLOGY
id: 0a33f487-4143-4967-b588-6bd0a0d0575b
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not a anticholinergic agent.
INDICATIONS AND USAGE
id: d28ae915-47a4-41f4-8da6-fd1c63d87bdb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Ranitidine 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 two times a day.
- 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: c6b2dfc6-d5ef-4be5-aa58-d9c9d3cf120e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Ranitidine is contraindicated in patients known to have hypersensitivity to the drug or any of the ingredients (see
PRECAUTIONS
).
ADVERSE REACTIONS
id: 413b872e-67fe-4a13-b8bd-78ae843cce83
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: 2fb61c75-a015-4a41-8bc2-a2405bb507e3
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 per 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 LD50 values in mice and rats were 77 and 83 mg/kg, respectively.
HOW SUPPLIED
id: a612662b-682b-4cfe-b451-261299dacaf1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Ranitidine Capsules, for oral administration, are available as:
150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder and supplied as:
NDC 21695-337-60 bottles of 60 capsules
300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder and supplied as:
NDC 21695-338-30 bottles of 30 capsules
Principal Display Panel
id: fb4da3d9-cd1c-44e4-bba9-98b636d10d79
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Principal Display Panel
id: dac7f049-d81b-4b79-8dd4-5a99df092a0f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
