DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

DIPHENOXYLATE (UNII: 73312P173G) (DIPHENOXYLATE - UNII:73312P173G), ATROPINE (UNII: 7C0697DR9I) (ATROPINE - UNII:7C0697DR9I)

Disponible desde:

RedPharm Drug, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diphenoxylate HCl and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. Diphenoxylate HCl 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 ). 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 diarrhea associated with pseudomembranous enterocolitis ( Clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, includin

Resumen del producto:

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available as a round, white, convex 2.5 mg/0.025 mg tablet, imprinted with LCI on one side and 1170 on the other side, supplied in bottles of 100, 500 and 1000 tablets. 100 Tablets        NDC 0527-1170-01 500 Tablets        NDC 0527-1170-05 1000 Tablets      NDC 0527-1170-10 Store below 25°C (77°F). This product’s label may have been updated. For current full prescribing information, please call 1-844-834-0530. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 CIB71133E Rev. 03/18

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE TABLET
REDPHARM DRUG, INC.
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DIPHENOXYLATE HCL & ATROPINE SULF TABS
DESCRIPTION
Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet, USP
contains:
2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of
diphenoxylate) and 0.025 mg of
atropine sulfate USP (equivalent to 0.01 mg of atropine)
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.
Inactive ingredients of diphenoxylate HCl and atropine sulfate tablets
include lactose monohydrate,
acacia, calcium stearate, methylcellulose, and cornstarch.
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 HCl 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