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Pregnancy: The safety of ipratropium bromide + salbutamol (Combivent UDV) during human pregnancy has not been established. The inhibitory effect of ipratropium bromide + salbutamol (Combivent UDV) on uterine contraction should be taken into account. The benefits of using ipratropium bromide + salbutamol (Combivent UDV) during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. The usual precautions regarding the use of drugs in pregnancy, especially during the first trimester, should be observed.
For ipratropium bromide, nonclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man. For salbutamol sulfate, non-inhalation, nonclinical studies did not indicate direct or indirect harmful effects unless the inhalation.
Maximum Recommended Human Daily Dose (MRHDD) was exceeded (see Pharmacology: Toxicology under Actions).
Lactation: It is not known whether ipratropium bromide and salbutamol sulfate are excreted in breast milk. It is considered unlikely that ipratropium bromide would reach the infant to an important extent, especially when administered by inhalation. However, caution should be exercised when ipratropium bromide + salbutamol (Combivent UDV) is administered to nursing mothers.
Fertility: No studies on the effect on human fertility have been conducted for Ipratropium bromide + Salbutamol (Combivent UDV). Clinical data on fertility are neither available for the combination of
ipratropium bromide and salbutamol sulphate nor for each of the two components of the combination.
Nonclinical studies performed with ipratropium bromide and salbutamol showed no adverse effect on fertility (see Pharmacology: Toxicology under Actions).
