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:

Marlex Pharmaceuticals Inc

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 1035-0680-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
MARLEX PHARMACEUTICALS INC
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PILOCARPINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED MARLEX
PHARMACEUTICALS, INC.
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PILOCARPINE HYDROCHLORIDE TABLETS USP, 5 MG RX ONLY
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
bi