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Motofen

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Motofen

Warnings
Precautions

WARNINGS

MOTOFEN (difenoxin and atropine) ® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO. MOTOFEN (difenoxin and atropine) ® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.

FLUID AND ELECTROLYTE BALANCE– THE USE OF MOTOFEN (difenoxin and atropine) ® DOES NOT PRECLUDE THE ADMINISTRATION OF APPROPRIATE FLUID AND ELECTROLYTE THERAPY. DEHYDRATION, PARTICULARLY IN CHILDREN, MAY FURTHER INFLUENCE THE VARIABILITY OF RESPONSE TO MOTOFEN (difenoxin and atropine) ® AND MAY PREDISPOSE TO DELAYED DIFENOXIN INTOXICATION. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE COLON, AND THIS MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE.

IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS MANIFESTED, MOTOFEN (difenoxin and atropine) ® SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED.

Ulcerative Colitis

In some patients with acute ulcerative colitis, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and MOTOFEN (difenoxin and atropine) ® therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.

Liver and Kidney Disease

MOTOFEN (difenoxin and atropine) ® (difenoxin hydrochloride with atropine sulfate) should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function tests since hepatic coma may be precipitated.

Atropine

A subtherapeutic dose of atropine has been added to difenoxin hydrochloride to discourage deliberate overdosage. Usage of MOTOFEN (difenoxin and atropine) ® in recommended doses is not likely to cause prominent anticholinergic side effects, but MOTOFEN (difenoxin and atropine) ® should be avoided in patients in whom anticholinergic drugs are contraindicated. The warnings and precautions for use of anticholinergic agents should be observed. In children, signs of atropinism may occur even with recommended doses of MOTOFEN (difenoxin and atropine) ®, particularly in patients with Down's Syndrome.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenesis was found in a long-term study of difenoxin hydrochloride/atropine in the rat. In this 104 week study, rats received dietary doses of 0, 1.25, 2.5, or 5 mg/kg/day difenoxin/atropine (20:1 ratio).

No experiments have been conducted to determine the mutagenic potential of MOTOFEN (difenoxin and atropine) ®. MOTOFEN (difenoxin and atropine) ® did not significantly impair fertility in rats.

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 (difenoxin and atropine) ® (difenoxin hydrochloride with atropine sulfate).

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 (difenoxin and atropine) ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from MOTOFEN (difenoxin and atropine) ®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

SAFETY AND EFFECTIVENESS IN CHILDREN BELOW THE AGE OF 12 HAVE NOT BEEN ESTABLISHED. MOTOFEN (difenoxin and atropine) ® IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS OF AGE. See OVERDOSAGE section for information on hazards from accidental poisoning in children.

Last reviewed on RxList: 5/12/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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