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, USP are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Product summary:

NDC: 71335-1225-1: 30 Tablets in a BOTTLE NDC: 71335-1225-2: 90 Tablets in a BOTTLE NDC: 71335-1225-3: 28 Tablets in a BOTTLE NDC: 71335-1225-4: 18 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
BRYANT RANCH PREPACK
----------
GLYCOPYRROLATE TABLETS USP
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.
Each glycopyrrolate tablet USP, intended for oral administration,
contains glycopyrrolate
equivalent to 1 mg or 2 mg. In addition, it also contains the
following inactive ingredients:
lactose monohydrate, dibasic calcium phosphate anhydrous, povidone,
sodium starch
glycolate and magnesium stearate.
The structural formula of glycopyrrolate is represented below:
Molecular Formula: C
H
BrNO
Molecular Weight: 398.33
Each tablet contains 1 mg or 2 mg of Glycopyrrolate, USP.
Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate,
pregelatinized
starch, magnesium stearate
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
19
28
3
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 eas