Montelukast Pregnancy

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Pregnancy of Montelukast in details

Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.

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

See references

Montelukast breastfeeding

When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!

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.

See references

References for pregnancy information

  1. "Product Information. Singulair (Montelukast)." Merck & Co, Inc, West Point, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Montelukast Sodium (Montelukast)." Ajanta Pharma USA, Bridgewater, NJ.
  4. Sarkar M, Koren G, Kalra S, et al. "Montelukast use during pregnancy: a multicentre, prospective, comparative study of infant outcomes." Eur J Clin Pharmacol 65 (2009): 1259-64
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Singulair (Montelukast)." Merck & Co, Inc, West Point, PA.
  2. "Product Information. Montelukast Sodium (Montelukast)." Ajanta Pharma USA, Bridgewater, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0



  1. PubMed Health. "Montelukast (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". (accessed September 17, 2018).
  2. Human Metabolome Database (HMDB). "Montelukast: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". (accessed September 17, 2018).
  3. FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". (accessed September 17, 2018).


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