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Salmeterol Pregnancy and Breastfeeding Warnings

Salmeterol is also known as: Serevent Diskus

Salmeterol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Physicians should be contacted if pregnancy occurs while taking this drug. -Beta-agonists, including this drug, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle.

Studies in rats showed no teratogenic effects at doses approximately 160 times the maximum recommended daily inhalation dose (MRHDID). In pregnant Dutch rabbits administered oral doses approximately 50 times the MRHDID, fetal toxic effects were observed characteristically resulting from beta-adrenoceptor stimulation (e.g., precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones). New Zealand White rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at an oral dose approximately 1,600 times the MRHDID. This drug crossed the placenta following oral administration to mice and rats. There are no well-controlled human trials that have investigated effects of this drug on pregnancy, preterm labor, or labor at term. AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Salmeterol Breastfeeding Warnings

Caution is recommended. Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Studies of HFA-134a revealed no effects on the reproductive performance and lactation of adult or two successive generations of rats or on the fetal development of rats or rabbits. Plasma levels of this drug after inhaled therapeutic doses are negligible and therefore levels in milk should be correspondingly low.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Severent (salmeterol)." Glaxo Wellcome, Research Triangle Park, NC.
  5. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Severent (salmeterol)." Glaxo Wellcome, Research Triangle Park, NC.
  5. Mcdonald CF, Burdon JGW "Asthma in pregnancy and lactation - a position paper for the thoracic society of australia and new zealand." Med J Aust 165 (1996): 485-8

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