PILOCARPINE HYDROCHLORIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Physicians Total Care, Inc.

DCI (Dénomination commune internationale):

PILOCARPINE HYDROCHLORIDE

Composition:

PILOCARPINE HYDROCHLORIDE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Pilocarpine hydrochloride tablets, 5 mg are white, film coated, round tablets, debossed LAN on one side and 1313 on the other side. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: Store at 20°- 25°C(68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Revised 06/09 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
----------
PILOCARPINE HYDROCHLORIDE TABLETS
RX ONLY
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 (3S-_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 are microcrystalline
cellulose and stearic acid, the
tablet's film coating is: polyvinyl alcohol, titanium dioxide,
polyethylene glycol, and talc.
Each 7.5 mg Pilocarpine Hydrochloride Tablet for oral administration
contains 7.5 mg of pilocarpine
hydrochloride. Inactive ingredients in the tablet are microcrystalline
cellulose and stearic acid, the
tablet's film coating is: FD&C Blue #2/Indigo Carmine aluminum lake,
polyvinyl alcohol, titanium
dioxide, polyethylene glycol, and talc.
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