PILOCARPINE HYDROCHLORIDE tablet, film coated PILOCARPINE HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

AMICI PHARMACEUTICALS LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Pilocarpine hydrochloride tablets, USP 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, USP 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.

Tuoteyhteenveto:

Pilocarpine Hydrochloride Tablets USP, 5 mg are round, white film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “116” on the other. They are supplied as follows: Bottles of 100 NDC 69292-274-10 Bottles of 500 NDC 69292-274-50 Pilocarpine Hydrochloride Tablets USP, 7.5 mg are round, blue film coated, biconvex, beveled edge tablet, debossed with “I” on one side and “117” on the other. They are supplied as follows: Bottles of 100 NDC 69292-275-10 Bottles of 500 NDC 69292-275-50 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Innogenix, LLC. Amityville, NY 11701 Distributed by: Amici Pharmaceuticals, LLC Melville, NY 11747 Rev. 10/2018

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AMICI PHARMACEUTICALS LLC
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PILOCARPINE HYDROCHLORIDE TABLETS USP, 5 MG AND 7.5 MGRX ONLY
DESCRIPTION
Pilocarpine hydrochloride tablets, USP 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 (3S-cis )-2(3H )-Furanone,
3-ethyl-dihydro-4-[(1-methyl-1H-
imidazol-5-yl)methyl] mono- hydrochloride, has a molecular weight of
244.72.
Each 5 mg Pilocarpine Hydrochloride Tablet, USP for oral
administration contains 5 mg of pilocarpine
hydrochloride. Inactive ingredients in the tablet and the tablet’s
film coating are: microcrystalline
cellulose, stearic acid and opadry II (White). Opadry II (White)
contains hypromellose, polydextrose,
polyethylene glycol, titanium dioxide and triacetin.
Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral
administration contains 7.5 mg of
pilocarpine hydrochloride. Inactive ingredients in the tablet and the
tablet’s film coating are:
microcrystalline cellulose, stearic acid and opadry II (Blue). Opadry
II (Blue) contains FD&C Blue
No.2, hypromellose, polydextrose, polyethylene glycol, titanium
dioxide 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