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:

American Health Packaging

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:

Pilocarpine Hydrochloride 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: Unit dose packages of 30 (5 x 6) NDC 68084-928-25 Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AMERICAN HEALTH PACKAGING
----------
PILOCARPINE HYDROCHLORIDE TABLETS
RX ONLY
8292821/0220F
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 _S-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 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
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 ma