GLYCOPYRROLATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Stason Pharmaceuticals

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

Descriptif du produit:

Glycopyrrolate Tablets, USP 1 mg are uncoated, round, flat face white tablets with beveled edge and debossed with “0475” on one side and bisected on the other. Glycopyrrolate Tablets, USP 1 mg in bottles of 100 (NDC 60763-481-02). Glycopyrrolate Tablets, USP 2 mg are uncoated, round, flat face white tablets with beveled edges and debossed with “0476” on one side and bisected on the other. Glycopyrrolate Tablets, USP 2 mg in bottles of 100 (NDC 60763-482-02). Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight container. Rx Only Manufactured By: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Stason Pharmaceuticals 888-598-7707 www.stasonpharma.com Made in the USA

Statut de autorisation:

Export only

Résumé des caractéristiques du produit

GLYCOPYRROLATE- GLYCOPYRROLATE TABLET
STASON PHARMACEUTICALS
----------
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.
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
19
28
3
acetylcholine on structures innervated by postganglionic cholinergic
nerves and on
smooth muscles that respond to acetylcholine by 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
p