PILOCARPINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Marlex Pharmaceuticals Inc

INN (International Name):

PILOCARPINE HYDROCHLORIDE

Composition:

PILOCARPINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Pilocarpine hydrochloride tablets USP, 5 mg are white, film coated, round tablets, debossed LAN on one side and 1313 on the other side. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: Bottles of 100; NDC 10135-0589-01 Store at 20°- 25°C (68°-77°F) [see USP Controlled Room Temperature]. Pilocarpine hydrochloride tablets USP, 7.5 mg are blue, film coated, round tablets, debossed LCI on one side and 1407 on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows: Bottles of 100; NDC 10135-0590-01 Store at 20°- 25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Distributed By: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Made in the USA Rev. 10/14 LAN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
MARLEX PHARMACEUTICALS INC
----------
PILOCARPINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Pilocarpine hydrochloride tablets, USP contain pilocarpine
hydrochloride, a cholinergic agonist for
oral use. Pilocarpine hydrochloride, USP 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, USP with a chemical name of
(3S-_cis_)-2(3_H_)-Furanone, 3-ethyldihydro-4-
[(1-methyl-1_H_-imidazol-5-yl) methyl] monohydrochloride, 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 are microcrystalline
cellulose and stearic acid, the
tablet’s film coating is: polyvinyl alcohol, titanium dioxide,
polyethylene glycol, and talc.
Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral
administration contains 7.5 mg of
pilocarpine hydrochloride. Inactive ingredients in the tablet are
microcrystalline cellulose and stearic
acid, the tablet’s film coating is: FD&C Blue #2/Indigo Carmine
aluminum lake, polyvinyl alcohol,
titanium dioxide, polyethylene glycol, and talc.
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 mus