GLYCOPYRROLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRROLATE - UNII:V92SO9WP2I)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

GLYCOPYRROLATE

Composition:

GLYCOPYRROLATE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For use as adjunctive therapy in the treatment of peptic ulcer. Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); 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.  Glycopyrrolate Tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Product summary:

Glycopyrrolate Tablets, USP are available in the following strengths and package sizes: Glycopyrrolate Tablets, USP 1 mg - White, Round Tablet; Debossed "WW" on the top of the score and "15" under score, plain on the other side.     Bottles of 100 Tablets Glycopyrrolate Tablets, USP 2 mg - White, Round Tablet; Debossed "WW" on top of score and "16" under score, plain on the other side.     Bottles of 100 Tablets    Store at 20-25˚C (68-77˚F) [See USP Controlled Room Temperature]. Protect from light and moisture.   Dispense in tight, light-resistant container as defined in the USP using a child-resistant closure.   Rx only   Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 0772 Revised February 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
WEST-WARD PHARMACEUTICAL CORP
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GLYCOPYRROLATE TABLETS, USP
RX ONLY
REVISED 02/11
DESCRIPTION
Glycopyrrolate Tablets, USP contain the synthetic anticholinergic,
glycopyrrolate. Glycopyrrolate is a
quaternary ammonium compound with the following chemical name:
3-[(cyclopentylhydroxyacetyl)oxy]-
1,1-dimethylpyrrolidinium bromide.
GLYCOPYRROLATE TABLETS, USP 1 MG are White, Round Tablets; Debossed
"WW" on the top of the
score and "15" under score, plain on the other side. Each tablet
contains:
Glycopyrrolate, USP………..1 mg
GLYCOPYRROLATE TABLETS, USP 2 MG are White, Round Tablets; Debossed
"WW" on top of score and
"16" under score, plain on the other side. Each tablet contains:
Glycopyrrolate, USP……….2 mg
INACTIVE INGREDIENTS: Dibasic Calcium Phosphate, Lactose Anhydrous,
Lactose Monohydrate,
Magnesium Stearate, Polyvinylpyrrolidone, Sodium Starch Glycolate.
CLINICAL PHARMACOLOGY
Glycopyrrolate, like other anticholinergic (antimuscarinic) agents,
inhibits the action of acetylcholine
on structures innervated by postganglionic cholinergic nerves and on
smooth muscles that respond to
acetylcholine but lack cholinergic innervation. These peripheral
cholinergic receptors are present in
the autonomic effector cells of smooth muscle, cardiac muscle, the
sino-atrial node, the atrioventricular
node, exocrine glands, and, to a limited degree, in the autonomic
ganglia. Thus, it diminishes the
volume and free acidity of gastric secretions and controls excessive
pharyngeal, tracheal, and bronchial
secretions.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,
bronchospasm, bradycardia, and
intestinal hypermotility) induced by cholinergic drugs such as the
anticholinesterases.
The highly polar quaternary ammonium group of glycopyrrolate limits
its passage across lipid
membranes, such as the blood-brain barrier, in contrast to atropine
sulfate and scopolamine
hydrobromide, which are non-polar tertiary amines which penetrate
lipid barriers easily.
INDICATION