Pentamidine Pregnancy and Breastfeeding Warnings

Pentamidine is also known as: Nebupent, Pentacarinat, Pentam, Pentam 300

Pentamidine Pregnancy Warnings

For HIV-infected women, the USPHS/IDSA (U.S. Public Health Service/Infectious Diseases Society of America) Prevention of Opportunistic Infections Working Group recommends that chemoprophylaxis be given during pregnancy when necessary to prevent the onset or recurrence of Pneumocystis pneumonia. Pentamidine is considered an option when trimethoprim-sulfamethoxazole, the drug of choice, may be contraindicated. A neonatal cord blood concentration of 13.2 mcg/L was measured 16.5 hours after the mother had received a 200 mg dose of intravenous pentamidine (3.4 mg/kg, the seventh daily dose while pregnant). The maternal blood concentration (free base) was 81.3 mcg/L, 8 hours after the same dose.

Pentamidine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality when administered intravenously to pregnant rats at 4 mg/kg/day. Teratogenicity due to pentamidine has not been demonstrated in animal studies when administered intravenously at dosages recommended for humans. It is not known if aerosolized pentamidine crosses the placenta a clinically significant levels. In one study, aerosolized pentamidine was administered to 15 patients during their second and third trimester. Serum concentrations in these women ranged from undetectable to 4.7 ng/mL. No adverse effects were reported in any of the infants. Another report of drug treatment of HIV infection during pregnancy included five patients receiving aerosolized pentamidine. Most of the mothers received multiple drugs during pregnancy. Albinism and growth retardation was reported in one infant each. There are no controlled data in human pregnancy and it is unknown if pentamidine can cause fetal harm when used during pregnancy. Pentamidine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Pentamidine Breastfeeding Warnings

There are no data on the excretion of pentamidine into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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