Asthalin Use In Pregnancy & Lactation

Pregnancy: There is no experience of this product in pregnancy and lactation in humans. Safety in pregnant women has not been established. No controlled clinical trials with salbutamol have been conducted in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). An inhalation reproductive study with a salbutamol sulphate CFC-free formulation in rats did not exhibit any teratogenic effects. It should not be used in pregnancy and lactation unless the expected benefit to the mother is thought to outweigh any risk to the fetus or neonate.
Propellant HFA 134a: There is no documented evidence of the use of salbutamol formulated with propellant HFA 134a in pregnant or lactating women. Studies of propellant HFA 134a administered to pregnant and lactating rats and rabbits have not revealed any special hazard.
Salbutamol: The safe use of inhaled salbutamol during pregnancy has not been established but it has been in widespread use for many years in human beings without apparent ill consequence. 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. However, in animal studies there was evidence of some harmful effects on the fetus at very high dose levels. In mice and rabbits large doses of salbutamol have been shown to be teratogenic.
Experience on the use of β-sympathomimetics during early pregnancy indicates no harmful effect at the doses ordinarily used for inhalation therapy. High systemic doses at the end of pregnancy can cause inhibition of labour and may induce β₂-specific foetal/neonatal effects like tachycardia and hypoglycaemia. Inhalation therapy at recommended doses is not expected to induce these harmful side effects at the end of pregnancy.
Breast-feeding: As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effects on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.
Fertility: There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions).