GLYCOPYRROLATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

American Health Packaging

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Glycopyrrolate Tablets USP, 1 mg are white to off-white, round, beveled edge uncoated tablets, debossed with 'Y' and break line on one side and '08' on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-458-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep this and all medication out of the reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Trademarks are the property of their respective owners.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
AMERICAN HEALTH PACKAGING
----------
GLYCOPYRROLATE TABLETS, USP
8445801/0419
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.
Each 1 mg tablet contains:
Glycopyrrolate, USP......... 1 mg
INACTIVE INGREDIENTS: dibasic calcium phosphate dihydrate, lactose
monohydrate,
magnesium Stearate, povidone, and 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.
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 d