PILOCARPINE HYDROCHLORIDE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NorthStar Rx LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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 16714-121-01  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 16714-122-01 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].   Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll number : 1-800-206-7821 Manufactured by: APL Healthcare Limited Unit-IV (MP SEZ), Tirupati (Dt)-524421 Andhra Pradesh, India. M.L.No.: 04/NLR/AP/2016/F/CC Revised: 09/2022

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
NORTHSTAR RX LLC
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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 tract,
gallb