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DIPHENOXYLATE Hydrochloride AND ATROPINE Sulfate Tablets, C-V (GREENSTONE LLC) Dosage and Administration

DOSAGE AND ADMINISTRATION

Management of Diarrhea in Patients 13 Years of Age and Older

Diphenoxylate hydrochloride and atropine sulfate is recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate. The use of diphenoxylate hydrochloride and atropine sulfate should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate until appropriate corrective therapy has been indicated (see WARNINGS).

Initial and Maximum Recommended Dosage in Patients 13 Years of Age and Older

The initial adult dosage is 2 diphenoxylate hydrochloride and atropine sulfate tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). Most patients will require this dosage until initial control of diarrhea has been achieved. Clinical improvement of acute diarrhea is usually observed within 48 hours.

Dosage after Initial Control of Diarrhea

After initial control has been achieved, the diphenoxylate hydrochloride and atropine sulfate dosage may be reduced to meet individual requirements. Control may often be maintained with as little as two diphenoxylate hydrochloride and atropine sulfate tablets daily.

Duration of Treatment

If clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue diphenoxylate hydrochloride and atropine sulfate as symptoms are unlikely to be controlled by further administration.

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