Consists of desloratadine, montelukast
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Desloratadine/montelukast Pregnancy |
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Consists of desloratadine, montelukast
Desloratadine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Desloratadine is only recommended for use during pregnancy when benefit outweighs risk.
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Desloratadine is excreted into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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Animal studies showed no adverse effects on embryofetal development at oral doses up to 400 mg/kg/day in rats or up to 100 mg/kg/day in rabbits. Retardation of fetal growth and development was observed in rabbits dosed at 200 mg/kg/day, a dose level associated with severe maternal toxicity. Fetal exposure of montelukast was demonstrated in both species. During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated with this drug during pregnancy. Most of these women were also taking other asthma medications during their pregnancy. A causal relationship between these events and this drug has not been established. There are no controlled data in human pregnancy". AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Use is not recommended unless clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B
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This drug should be used only if clearly needed. Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: : The effects in the nursing infant are unknown.
Studies in lactating rats have shown that this drug is excreted into milk following oral doses of 100 and 200 mg/kg/day, and growth of the pups was slightly inhibited at the higher dose level.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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