Pulmodual/Pulmodual MDI Use In Pregnancy & Lactation

Pulmodual: Pregnancy: Teratogenic Effects: Pregnancy Category C.
Ipratropium bromide + Salbutamol (Pulmodual) safety during pregnancy (human) has not been established. However, the use of drugs during pregnancy should be observed only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The use of Ipratropium bromide + Salbutamol (Pulmodual) for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh the risk because of the potential for beta-agonist interference with uterine contractility.
Nursing Mothers: The components of Ipratropium bromide and Salbutamol are excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipratropium bromide would reach the infant to an important extent, especially when taken by inhalation as a nebulized solution. However, caution should be exercised when administering to a nursing mother.
Pulmodual MDI: Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies of Salbutamol Sulphate and Ipratropium Bromide Inhalation in pregnant women. Animal reproduction studies have not been conducted with Salbutamol Sulphate and Ipratropium Bromide Inhalation. However, Salbutamol Sulphate has been shown to be teratogenic in mice and rabbits.
Salbutamol Sulphate and Ipratropium Bromide Inhalation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal studies with salbutamol have demonstrated a teratogenic effect. No evidence of abnormalities have been reported in women receiving salbutamol during pregnancy. Salbutamol has been given systemically to inhibit preterm labor. Use of salbutamol in pregnant women for relief of bronchospasm may interfere with uterine contractility.
Pulmonary edema has been associated with intravenous use of salbutamol in pregnant women. Metered dose Inhalations employ lower doses and result in lower plasma concentrations following administration, thereby producing fewer adverse effects for the mother and fetus. Ipratropium has failed to reveal evidence of teratogenicity in animal studies. There are no controlled data in human pregnancy. Salbutamol Sulphate and Ipratropium Bromide Inhalation is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Lactation: It is not known whether Salbutamol Sulphate and Ipratropium Bromide Inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling the doctor if the patient is breast-feeding a baby.