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:

Carilion Materials Management

INN (International Name):

PILOCARPINE HYDROCHLORIDE

Composition:

PILOCARPINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pilocarpine Hydrochloride 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. 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:

NDC:68151-3015-0 in a PACKAGE of 1 TABLET, FILM COATEDS

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
CARILION MATERIALS MANAGEMENT
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PILOCARPINE HYDROCHLORIDE TABLETS
IN-5496/S
RX ONLY
DESCRIPTION
Pilocarpine Hydrochloride 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 - )-2(3 )-Furanone,
3-ethyldihydro-4-[(1 -methyl-1 -imidazol-
5-yl) methyl] monohydrochloride, has a molecular weight of 244.72.
_ScisHH_
Each 5 mg Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride 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
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 to