SALAGEN- pilocarpine hyrochloride tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Eisai Inc.

INN (Algemene Internationale Benaming):

PILOCARPINE HYDROCHLORIDE

Samenstelling:

PILOCARPINE HYDROCHLORIDE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

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 62856-705-10 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 62856-775-10 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: Eisai Inc. Woodcliff Lake, NJ 07677 © 2018 Eisai Inc. June 2018 SALAGEN® is a registered trademark of Eisai Inc.

Autorisatie-status:

New Drug Application

Productkenmerken

SALAGEN- PILOCARPINE HYROCHLORIDE TABLET, FILM COATED
EISAI INC.
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SALAGEN
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, 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 m