displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Ranitidine hydrochloride (HCl), USP, is 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-ethene-diamine, HCl. It has the following structural formula:
The molecular formula is C 13H22N4O3S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.
Each tablet, for oral administration, contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each tablet contains the following inactive ingredients: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, synthetic yellow iron oxide, titanium dioxide and triethyl citrate.
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 an anticholinergic agent.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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 rantidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acuter 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 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.
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 150 mg b.i.d.
7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.
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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Ranitidine tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).
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.
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 1000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
150 mg tablets: peach to light-brown colored, round unscored tablets debossed“Par 544” on one side and plain on the other, supplied in blisters of 30 and 60 tablets.
Store at 15°-30°C (59°-86°F) in a dry place. Protect from light.
Par Pharmaceutical, iNC
Spring Valley, NY 10977
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4