Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)
Amneal Pharmaceuticals NY LLC
ORAL
PRESCRIPTION DRUG
Pilocarpine hydrochloride tablets are indicated for: - The treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. - 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 60219-5922-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Abbreviated New Drug Application
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED AMNEAL PHARMACEUTICALS NY LLC ---------- PILOCARPINE HYDROCHLORIDE TABLETS (5 MG) RX ONLY DESCRIPTION Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride,USP, a cholinergic agonist for oral use. Pilocarpine hydrochloride, USP is a white crystalline powder or colorless crystals, hygroscopic 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 g/mol. Each 5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride, USP. 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. 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 muscle tone may increase. The tone and motility of urinary tract, gallbladder, and biliary duct smooth muscle may be enhanced. Pilocarpine may have paradoxical effects on the cardiovascular system. The expected effect of a muscarinic agonist is vasodepressi Lue koko asiakirja