DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Atlantic Biologicals Corps

Designación común internacional (DCI):

DIPHENOXYLATE HYDROCHLORIDE

Composición:

DIPHENOXYLATE HYDROCHLORIDE 2.5 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea. Diphenoxylate hydrochloride and atropine sulfate is contraindicated in patients with: Diphenoxylate hydrochloride and atropine sulfate oral solution is classified as a Schedule V controlled substance by federal regulation. 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 hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administ

Resumen del producto:

Product: 17856-3194 NDC: 17856-3194-5 5 mL in a CUP

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION
ATLANTIC BIOLOGICALS CORPS
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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ORAL SOLUTION USP CV
RX ONLY
DESCRIPTION
Each 5 mL oral solution contains:
Diphenoxylate Hydrochloride
.......................................................................
2.5 mg
Atropine Sulfate
........................................................................................
0.025 mg
Alcohol
..............................................................................................................
15%
_Inactive Ingredients:_
The oral solution contains: alcohol, citric acid (anhydrous), FD&C Red
No. 40, FD&C Yellow No. 6,
glycerin, maltol, potassium sorbate, purified water, sorbitol solution
and wild cherry flavor.
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisoni-
pecotate monohydrochloride and has the following structural formula:
C30H32N2O2 · HCL M.W 4 89.05
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:
(C H NO ) · H SO · H2O M.W. 694 .83
A subtherapeutic amount of atropine sulfate is present to discourage
deliberate overdosage.
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
17
23
3 2
2
4
16-subject crossover bioavai