DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

RedPharm Drug, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: • Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS). • Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS). • Patients with known hypersensitivity to diphenoxylate or atropine. • Patients with obstructive jaundice. Controlled Substance Diphenoxylate hydrochloride and atropine sulfate tablets are classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. Drug Abuse and Dependence In do

Toote kokkuvõte:

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are available as round white tablets debossed ‘490’ on one side and plain on the other side. Each tablet contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate and are supplied as: NDC Number Size 62559-490-01 Bottle of 100 tablets 62559-490-10 Bottle of 1,000 tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature]. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9981 Rev 10/17

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE TABLET
REDPHARM DRUG, INC.
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DIPHENOXYLATE/ATROPINE
DESCRIPTION
Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet USP
contains:
Diphenoxylate Hydrochloride USP…. 2.5 mg
Atropine Sulfate USP...................... 0.025 mg
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl
1-(3-cyano-3,3-diphenylpropyl)-4-
phenylisonipecotate monohydrochloride and has the following structural
formula:
Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl)
benzeneacetic acid 8-methyl-8-
azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and
has the following structural
formula:
A subtherapeutic amount of atropine sulfate is present to discourage
deliberate overdosage.
Each diphenoxylate hydrochloride and atropine sulfate tablet contains
the following inactive
ingredients: confectioner’s sugar, corn starch, lactose monohydrate,
magnesium stearate, and sodium
starch glycolate.
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 four-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 crossover bioavailability study, a linear relationship in
the dose range of 2.5 to 10 mg was
found between the dose of diphenoxylate hydrochloride (given as
diphenoxylate hydrochloride and
atropine sulfate liquid) 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