GLYCOPYRROLATE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Bryant Ranch Prepack

INN (International namn):

GLYCOPYRROLATE

Sammansättning:

GLYCOPYRROLATE 2 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Tablet, USP are contraindicated in those patients with a hypersensitivity to glycopyrrolate. Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Produktsammanfattning:

NDC: 71335-0020-1: 30 Tablets in a BOTTLE NDC: 71335-0020-2: 90 Tablets in a BOTTLE NDC: 71335-0020-3: 28 Tablets in a BOTTLE NDC: 71335-0020-4: 18 Tablets in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
BRYANT RANCH PREPACK
----------
GLYCOPYRROLATE TABLETS, USP
1 MG AND 2 MG
RX ONLY
DESCRIPTION
Glycopyrrolate Tablet, USP 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, 1 mg
Each 2 mg tablet contains: Glycopyrrolate USP, 2 mg
INACTIVE INGREDIENTS: dibasic calcium phosphate, lactose, magnesium
stearate,
povidone, and sodium starch glycolate
ACTIONS
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
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 i