DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Lohxa

INN (Isem Internazzjonali):

DIPHENOXYLATE HYDROCHLORIDE

Kompożizzjoni:

DIPHENOXYLATE HYDROCHLORIDE 2.5 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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: - Known hypersensitivity to diphenoxylate or atropine. - Obstructive jaundice. - Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria. 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

Sommarju tal-prodott:

Diphenoxylate Hydrochloride 2.5 mg and Atropine Sulfate 0.025 mg per 5 mL Oral Solution USP The 2.5 mg/0.025 mg per 5 mL oral solution is supplied as a (cherry-flavored) clear, orange-colored solution. NDC 70166-630-01: 5mL Prefilled syringe Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Distr. by: Lohxa Worcester, MA 01608 Revised April 2018

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION
LOHXA
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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:
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.
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 d