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:

Amneal Pharmaceuticals of New York LLC

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—Each white to off-white, film-coated, round convex tablets, debossed with “G” on one side and “592” on the other side. They are available as follows: Bottles of 100:                                                NDC 0115-5922-01 Bottles of 1000:                                              NDC 0115-5922-03 Pilocarpine Hydrochloride Tablets, 7.5 mg—Each blue, film-coated, round convex tablets, debossed with “G” on one side and “591” on the other side. They are available as follows: Bottles of 100 :                                               NDC 0115-5911-01 Bottles of 1000:                                              NDC 0115-5911-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container (USP).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
PILOCARPINE HYDROCHLORIDE TABLETS
(5 MG AND 7.5 MG)
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 (3_S-cis_)-2(3_H_)-Furanone,
3-ethyl-dihydro-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 and the tablet’s
film coating are: colloidal silicon
dioxide, hypromellose Type 2910/ 3cP, 6cP, and 50cP, polyethylene
glycol, microcrystalline
cellulose, stearic acid, polydextrose, titanium dioxide, triacetate
and triacetin.
Each 7.5 mg pilocarpine hydrochloride 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,
polyethylene glycol, 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