Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Golden State Medical Supply, Inc.
ORAL
PRESCRIPTION DRUG
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.
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 60429-665-01). 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 60429-666-01). 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: Quinn Pharmaceuticals 954-755-0502 www.quinnrx.com Made in USA Rev: 03/2021 (4) R50242 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012
Abbreviated New Drug Application
GLYCOPYRROLATE- GLYCOPYRROLATE TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- 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 Aqra d-dokument sħiħ