Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
DIPHENOXYLATE HYDROCHLORIDE (UNII: W24OD7YW48) (DIPHENOXYLATE - UNII:73312P173G), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
American Health Packaging
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lugege kogu dokumenti