Fluomizin Use In Pregnancy & Lactation

Fluomizin can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Fluomizin to pregnant women in the 1st trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride (55) and in a drug utilization study with Fluomizin (60) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Data from post-marketing surveillance on a number of exposed pregnancies (estimated 0.5-1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Toxicology under Actions).
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse effects on the foetus or newborn are improbable.