SALAGEN- 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:

Concordia Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SALAGEN® Tablets 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. SALAGEN® 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:

SALAGEN® Tablets, 5 mg, are white, film coated, debossed round tablets, coded SAL 5. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 59212-705-10 bottles of 100 Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). SALAGEN® Tablets, 7.5 mg, are blue, film coated, debossed round tablets, coded SAL 7.5. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 59212-775-10 bottles of 100 Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured by: Patheon Inc., Ontario, L5N 7K9 Manufactured for: Concordia Pharmaceuticals Distributed by: Amdipharm Limited 17 Northwood House Dublin 9, Ireland ©2019. All rights reserved. Sep 2019 SALAGEN® is a registered trademark under exclusive license to Amdipharm Limited.

Authorization status:

New Drug Application

Summary of Product characteristics

SALAGEN - PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED
CONCORDIA PHARMACEUTICALS INC.
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SALAGEN
TABLETS
(PILOCARPINE HYDROCHLORIDE)
DESCRIPTION
SALAGEN Tablets 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
(3_S-cis_)-2(3_H_)-Furanone, 3-
ethyl-dihydro-4-[(1-methyl-1_H_-imidazol-5-yl)methyl]
mono-hydrochloride, has a
molecular weight of 244.72.
Each 5 mg SALAGEN Tablet for oral administration contains 5 mg of
pilocarpine
hydrochloride. Inactive ingredients in the tablet, the tablet’s film
coating, and polishing
are: carnauba wax, hypromellose, microcrystalline cellulose, stearic
acid, titanium dioxide
and other ingredients.
Each 7.5 mg SALAGEN Tablet for oral administration contains 7.5 mg of
pilocarpine
hydrochloride. Inactive ingredients in the tablet, the tablet’s film
coating, and polishing
are: carnauba wax, hypromellose, microcrystalline cellulose, stearic
acid, titanium
dioxide, FD&C blue#2 aluminum lake, and other ingredients.
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,
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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