Is Dione 21-acetate Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Dione 21-acetate? Is Dione 21-acetate safe for nursing mother and child? Does Dione 21-acetate extracts into breast milk? Does Dione 21-acetate has any long term or short term side effects on infants? Can Dione 21-acetate influence milk supply or can Dione 21-acetate decrease milk supply in lactating mothers?

It is excreted into breast milk in clinically non-significant amount, in fact a much lower amount than the dose used for the treatment or prophylaxis of infection in neonates and infants. Even more, no problems that would be attributable to rifampicin have been observed among infants whose mothers were taking this medication. It can cause an orange discoloration of body fluids, including the mother’s milk.Take into account possible negative results in bacterial cultures of febrile infants, when their mothers are on antibiotics. American Academy of Pediatrics states that it is usually compatible with breastfeeding medication.WHO List of Essential Medicines 2002: compatible with breastfeeding.

Limited information indicates that there are low levels of Dione 21-acetate in breastmilk that would not be expected to cause any adverse effects in breastfed infants. The amount of Dione 21-acetate in milk is insufficient to treat tuberculosis in the breastfed infant. The Centers for Disease Control and Prevention and other professional organizations state that breastfeeding should not be discouraged in women taking Dione 21-acetate.[1][2][3]

One woman taking Dione 21-acetate 450 mg, isoniazid 300 mg and ethambutol 1200 mg daily during pregnancy and Dione 21-acetate 450 mg and isoniazid 300 mg for the first 7 months of lactation (extent not stated). The infant was born with mildly elevated serum liver enzymes which persisted for to 1 (alanine transferase) to 2 years (aspartate transaminase), but had no other adverse reactions.[6] Dione 21-acetate was used as part of multi-drug regimens to treat 2 pregnant women with multidrug-resistant tuberculosis throughout pregnancy and postpartum. Their two infants were breastfed (extent and duration not stated). At age 3.9 and 5.1 years, the children were developing normally except for hyperactivity in one.[7] Two mothers in Turkey were diagnosed with tuberculosis at the 30th and 34th weeks of pregnancy. They immediately started isoniazid 300 mg, Dione 21-acetate 600 mg, pyridoxine 50 mg daily for 6 months, plus pyrazinamide 25 mg/kg and ethambutol 25 mg/kg daily for 2 months. Both mothers breastfed their infants (extent not stated). Their infants were given isoniazid 5 mg/kg daily for 3 months prophylactically. Tuberculin skin tests were negative after 3 months and neither infant had tuberculosis at 1 year of age. No adverse effects of the drugs were mentioned.[8] A woman with leprosy took clofazimine, dapsone and Dione 21-acetate during pregnancy and breastfeeding. Her infant developed skin discoloration attributed to clofazimine which reversed 3 months after cessation of breastfeeding.[9]