Diphenoxylate and Atropine (Diphenoxylate Hydrochloride / Atropine Sulfate) - Indications and Dosage

INDICATIONS AND USAGE

Diphenoxylate Hydrochloride and Atropine Sulfate tablets are effective as adjunctive therapy in the management of diarrhea.

DOSAGE AND ADMINISTRATION

DO NOT EXCEED RECOMMENDED DOSAGE.

Adults: The recommended initial dosage is two tablets four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily.

Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.

Children: Diphenoxylate HCl and Atropine Sulfate is not recommended in children under 2 years of age and should be used with special caution in young children (see WARNINGS and PRECAUTIONS ). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use oral solution. Do not use tablets for this age group.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

HOW SUPPLIED

Diphenoxylate Hydrochloride and Atropine Sulfate is available as a round, white, convex 2.5 mg/0.025 mg tablet, debossed LAN over 1170, 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 at controlled room temperature 20°-25°C (68°-77°F). (See USP)

Dispense in a well-closed container as defined in the USP.

MANUFACTURED BY
LANNETT CO., INC.
PHILADELPHIA, PA 19136

Rev. 08/07