Pregnancy Warnings

Pentamidine Pregnancy and Breast Feeding Warnings

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

Overview

It is unknown if Pentamidine Solution can cause harm to the fetus. If you become pregnant while taking Pentamidine Solution, discuss with your doctor the benefits and risks of using Pentamidine Solution during pregnancy. It is unknown if Pentamidine Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Pentamidine Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Pentamidine Pregnancy Warnings

Pentamidine has been assigned to pregnancy category C by the FDA. Teratogenicity due to pentamidine has not been demonstrated in animal studies when administered intravenously at dosages recommended for humans. 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. Pentamidine should only be given during pregnancy when benefit outweighs risk.

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 Lactation Warnings

There are no data on the excretion of pentamidine into human milk.

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