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:

Actavis Pharma, 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, debossed round tablets, coded SAL 5. Each tablet contains 5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 0228-2801-11 bottles of 100 with a child-resistant closure. Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Pilocarpine Hydrochloride Tablets, 7.5 mg, are blue, film coated, debossed round tablets, coded SAL 7.5. Each tablet contains 7.5 mg pilocarpine hydrochloride. They are supplied as follows: NDC 0228-2837-11 bottles of 100 with a child-resistant closure. Store up to 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 by: Patheon Inc. Ontario, Canada L5N 7K9 LF-121899-01                                                   Revised - January 2021 2000013377

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

PILOCARPINE HYDROCHLORIDE - PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
ACTAVIS PHARMA, INC.
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PILOCARPINE HYDROCHLORIDE TABLETS
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
(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 for oral administration
contains 5 mg of
pilocarpine hydrochloride. Inactive ingredients in the tablet, the
tablet's film coating, and
polishing are: carnauba wax, hypromellose, microcrystalline cellulose,
stearic acid,
titanium dioxide and other ingredients.
Each 7.5 mg Pilocarpine Hydrochloride Tablet for oral administration
contains 7.5 mg of
pilocarpine hydrochloride. Inactive ingredients in the tablet, the
tablet's film coating, and
polishing are: carnauba wax, hypromellose, microcrystalline cellulose,
stearic acid,
titanium dioxide, FD&C blue # 2 aluminum lake, and other ingredients.
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
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