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:

AMICI PHARMACEUTICALS LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Pilocarpine hydrochloride tablets, USP 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, USP 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 USP, 5 mg are round, white film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “116” on the other. They are supplied as follows: Bottles of 100 NDC 69292-265-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Innogenix, LLC. Amityville, NY 11701 Distributed by: Amici Pharmaceuticals, LLC Melville, NY 11747

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AMICI PHARMACEUTICALS LLC
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PILOCARPINE HYDROCHLORIDE TABLETS USP, 5 MG
DESCRIPTION
Pilocarpine hydrochloride tablets, USP 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 (3S-cis )-
2(3H )-Furanone, 3-ethyl-dihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]
mono-
hydrochloride, has a molecular weight of 244.72.
Each 5 mg Pilocarpine Hydrochloride Tablet, USP for oral
administration contains 5 mg
of pilocarpine hydrochloride. Inactive ingredients in the tablet and
the tablet’s film
coating are: microcrystalline cellulose, stearic acid and opadry II
(White). Opadry II
(White) contains hypromellose, polydextrose, polyethylene glycol,
titanium dioxide 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 vasodepression, but administration of pilocarpine may
produce