Pregnancy: Nebules/Accuhaler/Solution for Intravenous Infusion: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
During world-wide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with VENTOLIN. Some of the mothers were taking multiple medications during their pregnancies.
Because no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with salbutamol use cannot be established.
Inhaler: Studies in animals have shown reproductive toxicity. Safety in pregnant women has not been established. No controlled clinical trials with salbutamol have been conducted in pregnant women.
Rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft palate, limb defects and cardiac disorders) have been received. Some of the mothers were taking multiple medications during their pregnancies. VENTOLIN Inhaler should not be used during pregnancy unless clearly necessary.
Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh the potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Fertility: There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals.