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DOSAGE AND ADMINISTRATION
The recommended starting dose of MOTOFEN (difenoxin and atropine) ® tablets in adults is 2 tablets (2 mg), then 1 tablet (1 mg) after each loose stool or 1 tablet (1 mg) every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets (8 mg). In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary.
Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN (difenoxin and atropine) ® in this age group. MOTOFEN (difenoxin and atropine) ® is contraindicated in children under 2 years of age.
MOTOFEN (difenoxin and atropine) ® is available as a white, dye-free, five-sided, scored tablet with “0500” on the scored side and “V” on the other. Each tablet contains 1.0 mg difenoxin (as the hydrochloride salt) and 0.025 mg atropine sulfate. Supplied in bottles of 50 tablets (NDC 0187-0500-01) and in bottles of 100 tablets (NDC 0187-0500-02).
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Manufactured for : Valeant Pharmaceuticals International, 3300 Hyland Ave., Costa Mesa, CA 92626 U.S.A. By West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Rev. 12/04This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/12/2009
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