GLYCOPYRROLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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 2 mg are bisected, compressed white, round tablets debossed “K” above the bisect and “401” below the bisect on one side of the tablet, and plain on the other side. NDC: 71335-2119-1: 30 Tablets in a BOTTLE NDC: 71335-2119-2: 90 Tablets in a BOTTLE NDC: 71335-2119-3: 28 Tablets in a BOTTLE NDC: 71335-2119-4: 18 Tablets in a BOTTLE Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
BRYANT RANCH PREPACK
----------
GLYCOPYRROLATE
DESCRIPTION
Glycopyrrolate tablets contain the synthetic anticholinergic
glycopyrrolate.
Glycopyrrolate is a quaternary ammonium compound with the following
chemical name:
3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium
bromide. Its empirical
formula is C
H
BrNO , its molecular weight is 398.33, and its structural formula is:
Each 1 mg tablet contains: Glycopyrrolate, USP 1mg
Each 2 mg tablet contains: Glycopyrrolate, USP 2mg
Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium
Stearate,
Povidone, 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.
19
28
3
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,
pyloroduod