Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Pilocarpine Hydrochloride (UNII: 0WW6D218XJ) (Pilocarpine - UNII:01MI4Q9DI3)
Rebel Distributors Corp
Pilocarpine Hydrochloride
Pilocarpine Hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
Pilocarpine HCl 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 HCl 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 HCl Tablets , 5 mg—Each white to off white, film-coated, round convex tablets, debossed with "G" on one side and "592" on the other side. Bottles of 90 NDC 21695-601-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container (USP).
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET REBEL DISTRIBUTORS CORP ---------- PILOCARPINE HYDROCHLORIDE TABLETS, 5 MG RX ONLY DESCRIPTION Pilocarpine HCl 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 HCl Tablet for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet and the tablet's film coating are: colloidal silicon dioxide, hypromellose Type 2910/ 3cP, 6cP, and 50cP, macrogol, microcrystalline cellulose, stearic acid, polydextrose, titanium dioxide, triacetate and triacetin. Each 7.5 mg Pilocarpine HCl Tablet for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet and the tablet's film coating are: colloidal silicon dioxide, FD&C blue #2/indigo carmine aluminum lake, hypromellose type 2910/ 3cP, and 6cP, macrogol, microcrystalline cellulose, stearic acid, polydextrose, titanium dioxide, triacetate 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, incr Aqra d-dokument sħiħ