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:

BAYSHORE PHARMACEUTICALS LLC

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 Tablets, USP 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. Not applicable.

Product summary:

Methscopolamine Bromide Tablets, USP 2.5 mg are available as white, round tablets, debossed with "BY1" on one side and plain on the other side, in the following package size: Bottles of 100 (NDC 76385-100-01) Methscopolamine Bromide Tablets, USP 5 mg are available as white, oval tablets, debossed with "BY2" on one side and plain on the other side, in the following package size: Bottles of 60 (NDC 76385-101-60) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHSCOPOLAMINE BROMIDE- METHSCOPOLAMINE BROMIDE TABLET
BAYSHORE PHARMACEUTICALS LLC
----------
METHSCOPOLAMINE BROMIDE TABLETS, USP 2.5 MG AND 5 MG
BAYSHORE PHARMACEUTICALS LLC
RX ONLY
DESCRIPTION
Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain
methscopolamine bromide USP, 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 Tablets, USP 2.5 mg for oral administration
contain 2.5 mg of
methscopolamine bromide USP. Methscopolamine Bromide Tablets, USP 5 mg
for oral administration
contain 5 mg of methscopolamine bromide USP.
Inactive ingredients: microcrystalline cellulose NF, pregelatinized
starch NF, colloidal silicon dioxide
NF, magnesium stearate NF.
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 to 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
excre