Description

Miltefosine did not inhibit human cytochrome P450 enzymes in vitro. Miltefosine did not induce cytochrome 3A activity in rats.

Pregnancy: Miltefosine should not be used during pregnancy. Obtain a urine or serum pregnancy test in females of reproductive potential prior to prescribing. Nursing Mothers: Discontinue drug or nursing depending on the importance of drug to the mother. Avoid breastfeeding for 5 months after Miltefosine therapy. Females and Males of Reproductive Potential: Advise females to use effective contraception during therapy and for 5 months after therapy. Advise patients of reproductive toxicities in animals, and that the potential for impaired fertility in humans has not been adequately evaluated

Embryo-Fetal Toxicity. Do not use in pregnant women. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential. Reproductive effects. Miltefosine caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Advise patients of reproductive toxicities in animal studies and that the potential effects on human fertility have not been adequately evaluated. Renal Effects. Monitor serum creatinine during therapy and for 4 weeks after end of therapy. Hepatic Effects. Monitor transaminases and bilirubin during therapy. Gastrointestinal Effects. Encourage fluid intake. Thrombocytopenia. Monitor platelet count during therapy for visceral leishmaniasis. Absorption of Oral Contraceptives. Advise use of alternative method of contraception if vomiting and/or diarrhea occur. Stevens-Johnson syndrome. Discontinue miltefosine.

Leishmaniacides

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.