País: Estados Unidos
Língua: inglês
Origem: 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 69292-274-10 Bottles of 500 NDC 69292-274-50 Pilocarpine Hydrochloride Tablets USP, 7.5 mg are round, blue film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “117” on the other. They are supplied as follows: Bottles of 100 NDC 69292-275-10 Bottles of 500 NDC 69292-275-50 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 Rev. 10/2018
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED AMICI PHARMACEUTICALS LLC ---------- PILOCARPINE HYDROCHLORIDE TABLETS USP, 5 MG AND 7.5 MGRX ONLY 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. Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet and the tablet’s film coating are: microcrystalline cellulose, stearic acid and opadry II (Blue). Opadry II (Blue) contains FD&C Blue No.2, 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 Leia o documento completo