国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
Marlex Pharmaceuticals Inc
PILOCARPINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE 5 mg
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 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 white, film coated, round tablets, debossed LAN on one side and 1313 on the other side. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: Bottles of 100; NDC 10135-0589-01 Store at 20°- 25°C (68°-77°F) [see USP Controlled Room Temperature]. Pilocarpine hydrochloride tablets USP, 7.5 mg are blue, film coated, round tablets, debossed LCI on one side and 1407 on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows: Bottles of 100; NDC 10135-0590-01 Store at 20°- 25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Distributed By: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Made in the USA Rev. 10/14 LAN
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED MARLEX PHARMACEUTICALS INC ---------- PILOCARPINE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride, USP 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, USP with a chemical name of (3S-_cis_)-2(3_H_)-Furanone, 3-ethyldihydro-4- [(1-methyl-1_H_-imidazol-5-yl) methyl] monohydrochloride, 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 are microcrystalline cellulose and stearic acid, the tablet’s film coating is: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet’s film coating is: FD&C Blue #2/Indigo Carmine aluminum lake, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. 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 mus 完全なドキュメントを読む