METHSCOPOLAMINE BROMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHSCOPOLAMINE BROMIDE (UNII: RTN51LK7WL) (METHSCOPOLAMINE - UNII:VDR09VTQ8U)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

METHSCOPOLAMINE BROMIDE

Composition:

METHSCOPOLAMINE BROMIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Methscopolamine Bromide 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets are contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. Not applicable.

Product summary:

Methscopolamine Bromide 2.5 mg Tablets are available as white, round tablets, debossed with “F” on one side and “482” on the other side, in the following package size: Bottles of 100 (NDC 0168-0482-99) Methscopolamine Bromide 5 mg Tablets are available as white, oval tablets, debossed with “F” on one side and “483” on the other side, in the following package size: Dose Pack (5 blisters of 12 tablets) Box of 60 (NDC 0168-0483-60) Store at 15°-30°C (59°-86°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

METHSCOPOLAMINE BROMIDE- METHSCOPOLAMINE BROMIDE TABLET
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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METHSCOPOLAMINE BROMIDE 2.5 MG TABLETS
METHSCOPOLAMINE BROMIDE 5 MG TABLETS
DESCRIPTION
Methscopolamine Bromide 2.5 mg Tablets/Methscopolamine Bromide 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 [3.3.1.0
] 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:
Methscopolamine Bromide 2.5 mg Tablets for oral administration contain
2.5 mg of methscopolamine
bromide. Methscopolamine Bromide 5 mg Tablets for oral administration
contain 5 mg of
methscopolamine bromide.
Inactive ingredients: microcrystalline cellulose, pregelatinized
starch, magnesium stearate.
Contains no lactose.
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.
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.
Little is known of the fate and
2,4
1,2
1
absorption from