PILOCARPINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pilocarpine Hydrochloride (UNII: 0WW6D218XJ) (Pilocarpine - UNII:01MI4Q9DI3)

Available from:

Rebel Distributors Corp

INN (International Name):

Pilocarpine Hydrochloride

Composition:

Pilocarpine Hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pilocarpine HCl 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 HCl 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 HCl Tablets , 5 mg—Each white to off white, film-coated, round convex tablets, debossed with "G" on one side and "592" on the other side. Bottles of 90     NDC 21695-601-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
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PILOCARPINE HYDROCHLORIDE TABLETS,
5 MG
RX ONLY
DESCRIPTION
Pilocarpine HCl 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 HCl Tablet for oral administration contains 5 mg
of pilocarpine hydrochloride.
Inactive ingredients in the tablet and the tablet's film coating are:
colloidal silicon dioxide,
hypromellose Type 2910/ 3cP, 6cP, and 50cP, macrogol, microcrystalline
cellulose, stearic acid,
polydextrose, titanium dioxide, triacetate and triacetin.
Each 7.5 mg Pilocarpine HCl Tablet for oral administration contains
7.5 mg of pilocarpine
hydrochloride. Inactive ingredients in the tablet and the tablet's
film coating are: colloidal silicon
dioxide, FD&C blue #2/indigo carmine aluminum lake, hypromellose type
2910/ 3cP, and 6cP,
macrogol, microcrystalline cellulose, stearic acid, polydextrose,
titanium dioxide, triacetate and
triacetin.
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, incr