PILOCARPINE HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)

Disponível em:

Amneal Pharmaceuticals NY LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AMNEAL PHARMACEUTICALS NY LLC
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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