Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Alembic Labs LLC
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 are contraindicated in those patients with a hypersensitivity to glycopyrrolate.
Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and “305” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets (NDC 15955-305-01) Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and “318” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets (NDC 15955-318-01) Store at 20˚to 25˚C (68˚to 77˚F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Keep this and all drugs out of the reach of children. Rx only Manufactured By: Appco Pharma LLC Piscataway, NJ 08854 Manufactured For: Alembic Labs LLC West Caldwell, NJ 07006 Rev. 12/2020
Abbreviated New Drug Application
GLYCOPYRROLATE - GLYCOPYRROLATE TABLET ALEMBIC LABS LLC ---------- GLYCOPYRROLATE TABLETS, USP RX ONLY 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. GLYCOPYRROLATE TABLETS 1 MG are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “305” below bisect. Each tablet contains: Glycopyrrolate, USP..........................1 mg GLYCOPYRROLATE TABLETS 2 MG are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “318” below bisect. Each tablet contains: Glycopyrrolate, USP..........................2 mg INACTIVE INGREDIENTS: Copovidone, Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium Stearate, 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 adjunctiv Lire le document complet