DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

American Health Packaging

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 ). - 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 HCl 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 doses used for the treatment of diarrhea, whether ac

Tóm tắt sản phẩm:

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: Unit dose packages of 100 (10 x 10) NDC 60687-569-01 Store below 25°C (77°F). This product’s label may have been updated. For current full prescribing information, please call American Health Packaging at 1-800-707-4621. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE- DIPHENOXYLATE
HYDROCHLORIDE AND ATROPINE SULFATE TABLET
AMERICAN HEALTH PACKAGING
----------
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS, USP, FOR
ORAL USE,
CV
8456901/0520
RX ONLY
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 concentrati