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:

Aurobindo Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 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.

Product summary:

Pilocarpine Hydrochloride Tablets, USP 5 mg are off white to white colour, biconvex round shaped film-coated tablet debossed with “PIL” on one side and “5” on the other side. Each tablet contains 5 mg pilocarpine hydrochloride USP. They are supplied as follows:          Bottles of 100                                   NDC 59651-224-01  Pilocarpine Hydrochloride Tablets, USP 7.5 mg are light blue to blue colour, biconvex round shaped film-coated tablet debossed with “PIL” on one side and “7.5” on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride USP. They are supplied as follows:                                                                                                                                   Bottles of 100                                   NDC 59651-225-01 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 09/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AUROBINDO PHARMA LIMITED
----------
PILOCARPINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Pilocarpine hydrochloride tablets, USP contain pilocarpine
hydrochloride, a cholinergic
agonist for oral use. Pilocarpine hydrochloride is a white or almost
white, crystalline
powder or colorless crystals, hygroscopic which is very soluble in
water and freely
soluble in ethanol (96 percent). 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, USP for oral
administration contains 5 mg of
pilocarpine hydrochloride USP. Inactive ingredients in the tablet are:
hypromellose,
microcrystalline cellulose, polyethylene glycol, stearic acid and
titanium dioxide.
Each 7.5 mg pilocarpine hydrochloride tablet, USP for oral
administration contains 7.5
mg of pilocarpine hydrochloride USP. Inactive ingredients in the
tablet are: FD&C blue #
2, hypromellose, microcrystalline cellulose, polyethylene glycol,
stearic acid and titanium
dioxide.
FDA approved dissolution test specifications differ from USP.
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 trac