GLYCOPYRROLATE- glycopyrrolate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)

Available from:

Mylan Institutional Inc.

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 1 mg are white, round, scored, flat-faced, beveled edge, debossed "3180" on one side and debossed "V" on the reverse side. They are supplied as follows: NDC 51079-700-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-10771 R1 10/12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
MYLAN INSTITUTIONAL INC.
----------
GLYCOPYRROLATE TABLETS, USP
1 MG AND 2 MG
RX ONLY
DESCRIPTION
Glycopyrrolate Tablets, USP contain the synthetic anticholinergic,
glycopyrrolate. Glycopyrrolate is a
quaternary ammonium compound with the following chemical name: 3-
[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium
bromide.
The structural formula of Glycopyrrolate is represented below:
Glycopyrrolate is supplied as 1 mg and 2 mg tablets.
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.
INDICATIONS AND USAGE
For use as adjunctive therapy in the treatment of peptic ulcer.
CONTRAINDICATIONS
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 ulce