Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
Amneal Pharmaceuticals of New York LLC
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—Each white to off-white, film-coated, round convex tablets, debossed with “G” on one side and “592” on the other side. They are available as follows: Bottles of 100: NDC 0115-5922-01 Bottles of 1000: NDC 0115-5922-03 Pilocarpine Hydrochloride Tablets, 7.5 mg—Each blue, film-coated, round convex tablets, debossed with “G” on one side and “591” on the other side. They are available as follows: Bottles of 100 : NDC 0115-5911-01 Bottles of 1000: NDC 0115-5911-03 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, FILM COATED AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- PILOCARPINE HYDROCHLORIDE TABLETS (5 MG AND 7.5 MG) 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-ethyl-dihydro-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 and the tablet’s film coating are: colloidal silicon dioxide, hypromellose Type 2910/ 3cP, 6cP, and 50cP, polyethylene glycol, microcrystalline cellulose, stearic acid, polydextrose, titanium dioxide, triacetate and triacetin. Each 7.5 mg pilocarpine hydrochloride 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, polyethylene glycol, 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 Lesen Sie das vollständige Dokument