Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
Actavis Pharma, Inc.
PILOCARPINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Pilocarpine Hydrochloride Tablets 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, 5 mg, are white, film coated, debossed round tablets, coded SAL 5. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 0228-2801-11 bottles of 100 with a child-resistant closure. Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Pilocarpine Hydrochloride Tablets, 7.5 mg, are blue, film coated, debossed round tablets, coded SAL 7.5. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 0228-2837-11 bottles of 100 with a child-resistant closure. Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 by: Patheon Inc. Ontario, Canada L5N 7K9 LF-121899-01 Revised - January 2021 2000013377
New Drug Application Authorized Generic
PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED ACTAVIS PHARMA, INC. ---------- PILOCARPINE HYDROCHLORIDE TABLETS PILOCARPINE HYDROCHLORIDE TABLETS Rx Only DESCRIPTION Pilocarpine Hydrochloride Tablets 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 (3_S_-_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 for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet's film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide and other ingredients. Each 7.5 mg Pilocarpine Hydrochloride Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet, the tablet's film coating, and polishing are: carnauba wax, hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, FD&C blue # 2 aluminum lake, and other ingredients. 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 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 Прочитајте комплетан документ