DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DIPHENOXYLATE HYDROCHLORIDE (UNII: W24OD7YW48) (DIPHENOXYLATE - UNII:73312P173G), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)

Disponibil de la:

Aidarex Pharmaceuticals LLC

INN (nume internaţional):

DIPHENOXYLATE HYDROCHLORIDE

Compoziție:

DIPHENOXYLATE HYDROCHLORIDE 2.5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients with - Known hypersensitivity to diphenoxylate or atropine, - Obstructive jaundice, - Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria. Diphenoxylate hydrochloride and atropine sulfate tablets are classified as a Schedule V controlled substance. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of diphenoxylate hydrochlor

Rezumat produs:

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white round, unscored tablets debossed with M over 15 on one side of the tablet and blank on the other side. They are available as follows: NDC 33261-0685-15 bottles of 15 tablets NDC 33261-0685-30 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Pharmacist: Dispense with a child-resistant closure only. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 REVISED NOVEMBER 2009 DPXAS:R12

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE TABLET
AIDAREX PHARMACEUTICALS LLC
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DIPHENOX W ATROP 2 5 0 025MG FOR MYLAN
DESCRIPTION
Each tablet for oral administration contains:
diphenoxylate
hydrochloride, USP 2.5 mg
(Warning – May be habit forming)
atropine
sulfate, USP 0.025 mg
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,
3-diphenylpropyl)-4-phenyl-
isonipecotate monohydrochloride and has the following structure:
Atropine sulfate, an anticholinergic, is
endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-
azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and
has the following structure:
A subtherapeutic amount of atropine sulfate is present to discourage
deliberate overdosage.
Each tablet for oral administration contains the following inactive
ingredients: colloidal silicon dioxide,
microcrystalline cellulose, pregelatinized starch and stearic acid.
CLINICAL PHARMACOLOGY
Diphenoxylate is rapidly and extensively metabolized in man by ester
hydrolysis to diphenoxylic acid
(difenoxine), which is biologically active and the major metabolite in
the blood. After a 5 mg oral dose
of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution
was given to three healthy
volunteers, an average of 14% of the drug plus its metabolites was
excreted in the urine and 49% in the
feces over a 4-day period. Urinary excretion of the unmetabolized drug
constituted less than 1% of the
dose, and diphenoxylic acid plus its glucuronide conjugate constituted
about 6% of the dose. In a 16
subject cross-over bioavailability study, a linear relationship in the
dose range of 2.5 mg to 10 mg was
found between the dose of diphenoxylate hydrochloride (given as
Diphenoxylate Hydrochloride and
Atropine Sulfate Oral Solution) and the peak plasma concentration, the
area under the plasma
concentration-time curve, and the amount of diphenoxylic acid excreted
in the urine. In the same study
the bioavailability of the tablet c