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Drug Catalog - Product Detail

METHSCOPOLAMINE BROMIDE, USP TB 5MG 60

NDC Mfr Size Str Form
64376-0604-61 PAR PHARMACEUTICAL 60 5MG TABLET
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Description
DESCRIPTION Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg contain methscopolamine bromide, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa–9–azoniatricyclo [3.3.1.0 2,4 ] nonane,7-(3-hydroxy-1-oxo-2-phenyl-propoxy)-9,9-dimethyl-, bromide, [7(S)-(1α, 2β,4β, 5α,7β)]-and the molecular weight is 398.30. The structural formula is represented below: Methscopolamine Bromide Tablets USP, 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide. Methscopolamine Bromide Tablets USP, 5 mg for oral administration contain 5 mg of methscopolamine bromide. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate. Contains no lactose. 6614692b-figure-01
How Supplied
HOW SUPPLIED Methscopolamine Bromide Tablets USP, 2.5 mg tablets are available as white, round tablets, debossed with “BOCA” on one side, debossed “603” on opposite: Bottles of 100 (NDC 64376-603-01) Methscopolamine Bromide Tablets USP, 5 mg tablets are available as white, oval-shaped tablets, debossed with “BOCA” on one side, debossed “604” on opposite: Bottles of 60 (NDC 64376-604-61) Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Indications & Usage
INDICATIONS AND USAGE Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.
Dosage and Administration
DOSAGE AND ADMINISTRATION The average dosage of Methscopolamine Bromide Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects. If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions. Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects. The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.