Pamine® 2.5 mg/Pamine® Forte 5 mg Tablets
DESCRIPTION
Pamine® 2.5 mg/Pamine® Forte 5 mg Tablets 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 [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]- and the molecular weight is 398.30.
The structural formula is represented below:
Pamine® 2.5 mg Tablets for oral administration contain 2.5 mg of methscopolamine bromide. Pamine® Forte 5 mg Tablets for oral administration contain 5 mg of methscopolamine bromide.
Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.
Contains no lactose.
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CLINICAL PHARMACOLOGY
Methscopolamine bromide is an anticholinergic agent which possesses most of the pharmacologic actions of that drug class. These include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. Large doses may result in tachycardia.
PHARMACOKINETICS
Methscopolamine bromide is a quaternary ammonium derivative of scopolamine. As a class, these agents are poorly and unreliably absorbed.1,2 Total absorption of quaternary ammonium derivatives of the alkaloids is 10-25%. Rate of absorption is not available. Quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor.1 Little is known of the fate and excretion of most of these agents.1 Following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours.2 Methscopolamine bromide has limited ability to cross the blood-brain barrier.3,4,5 The drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces.2 There is no data on the presence of methscopolamine in breast milk; traces of atropine have been found after administration of atropine.1
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