PILOCARPINE HYDROCHLORIDE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

AvPAK

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 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.

제품 요약:

Pilocarpine hydrochloride tablets USP, 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: NDC 50268-652-12 (10 tablets per card, 2 cards per carton). For Institutional Use Only. Dispensed in Unit Dose Package. Store at 20°- 25°C(68°-77°F) [see USP Controlled Room Temperature]. Pilocarpine hydrochloride tablets USP, 7.5 mg are blue, film coated, round tablets, debossed LCI on one side and 1407 on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride. Store at 20°- 25°C(68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 05/20 AV 12/20 (P) AvPAK

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE TABLET, FILM
COATED
AVPAK
----------
PILOCARPINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION:
Pilocarpine hydrochloride tablets, USP contain pilocarpine
hydrochloride, a cholinergic
agonist for oral use. Pilocarpine hydrochloride, USP 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, USP
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, USP 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, USP 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