Difenoxin And Atropine Sulfate Interactions

Brand names: Motofen

Route: Oral

Contraindications

CONTRAINDICATIONS MOTOFEN ® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella species, Shigella ) and pseudomembranous colitis associated with broad spectrum antibiotics. Antiperistaltic agents should not be used in the conditions because they may prolong and/or worsen diarrhea. MOTOFEN ® is contraindicated in children under 2 years of age because of the decreased margin of safety of drugs in this class in younger age groups. MOTOFEN ® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.

Pregnancy & Breastfeeding

Pregnancy/Teratogenic Effects Pregnancy Category C. Reproduction studies in rats and rabbits with doses at 31 and 61 times the human therapeutic dose respectively, on a mg/kg basis, demonstrated no evidence of teratogenesis due to MOTOFEN ® . Pregnant rats receiving oral doses of difenoxin hydrochloride/atropine 20 times the maximum human dose had an increase in delivery time as well as a significant increase in the percent of stillbirths. Neonatal survival in rats was also reduced with most deaths occurring within four days of delivery. There are no well controlled studies in pregnant women. MOTOFEN ® should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

4 interactions on record