Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
AMICI PHARMACEUTICALS LLC
ORAL
PRESCRIPTION DRUG
Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome. Pilocarpine hydrochloride tablets, USP are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
Pilocarpine Hydrochloride Tablets USP, 5 mg are round, white film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “116” on the other. They are supplied as follows: Bottles of 100 NDC 69292-265-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Innogenix, LLC. Amityville, NY 11701 Distributed by: Amici Pharmaceuticals, LLC Melville, NY 11747
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED AMICI PHARMACEUTICALS LLC ---------- PILOCARPINE HYDROCHLORIDE TABLETS USP, 5 MG DESCRIPTION Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride with a chemical name of (3S-cis )- 2(3H )-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] mono- hydrochloride, has a molecular weight of 244.72. Each 5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet and the tablet’s film coating are: microcrystalline cellulose, stearic acid and opadry II (White). Opadry II (White) contains hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. CLINICAL PHARMACOLOGY PHARMACODYNAMICS: Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands and the mucous cells of the respiratory tract may be stimulated. When applied topically to the eye as a single dose it causes miosis, spasm of accommodation, and may cause a transitory rise in intraocular pressure followed by a more persistent fall. Dose-related smooth muscle stimulation of the intestinal tract may cause increased tone, increased motility, spasm, and tenesmus. Bronchial smooth muscle tone may increase. The tone and motility of urinary tract, gallbladder, and biliary duct smooth muscle may be enhanced. Pilocarpine may have paradoxical effects on the cardiovascular system. The expected effect of a muscarinic agonist is vasodepression, but administration of pilocarpine may produce Pročitajte cijeli dokument