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Albuterol / ipratropium Pregnancy and Breastfeeding Warnings

Albuterol / ipratropium is also known as: Combivent, Combivent Respimat, DuoNeb

Albuterol / ipratropium Pregnancy Warnings

Albuterol-ipratropium has been assigned to pregnancy category C by the FDA. Animal studies with albuterol have demonstrated a teratogenic effect. No evidence of abnormalities have been reported in women receiving albuterol during pregnancy. Albuterol has been given systemically to inhibit preterm labor. Use of albuterol in pregnant women for relief of bronchospasm may interfere with uterine contractility. Pulmonary edema has been associated with intravenous use of albuterol in pregnant women. Metered dose inhalers 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. Albuterol-ipratropium is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

One malformation, a renal obstruction, occurred with ipratropium use between 1982 and 1994 among 37 women who took this drug during the first trimester according to data taken from a study of Medicaid patients. One study of 12 pregnant asthmatics between 33 and 39 weeks gestation showed no significant effect of inhaled albuterol on maternal or fetal circulations. For the two hours immediately following a dose of two deep inhalations of 0.5% solution, no significant effect was seen on maternal blood pressure or heart rate, umbilical artery systolic/diastolic ratio, fetal aortic velocities or heart rate.

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Albuterol / ipratropium Breastfeeding Warnings

There are no data on the excretion of albuterol or ipratropium into human milk. 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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References for pregnancy information

  1. Lind T, Godfrey KA, Gerrard J, Bryson MR "Continuous salbutamol infusion over 17 weeks to pre-empt premature labour." Lancet 2 (1980): 1165-6
  2. Tan SN "Peri-partum pulmonary oedema." Anaesth Intensive Care 19 (1991): 111-3
  3. Rayburn WF, Atkinson BD, Gilbert K, Turnbull GL "Short-term effects of inhaled albuterol on maternal and fetal circulations." Am J Obstet Gynecol 171 (1994): 770-3
  4. Hawker F "Five cases of pulmonary oedema associated with beta 2-sympathomimetic treatment of premature labour." Anaesth Intensive Care 12 (1984): 159-62
  5. Watson NA, Morgan B "Pulmonary oedema and salbutamol in preterm labour. Case report and literature review." Br J Obstet Gynaecol 96 (1989): 1445-8
  6. Martin AJ "Severe unwanted effects associated with betasympathomimetics when used in the treatment of premature labour: causes, incidence and preventative measures." Br J Clin Pract 35 (1981): 325-9
  7. Lunell NO, Joelsson I, Bjorkman U, Lamb P, Persson B "The use of salbutamol in obstetrics." Acta Obstet Gynecol Scand 55 (1976): 333-6
  8. Davies AE, Robertson MJ "Pulmonary oedema after the administration of intravenous salbutamol and ergometrine. Case report." Br J Obstet Gynaecol 87 (1980): 539-41
  9. "Product Information. Combivent (albuterol-ipratropium)." Boehringer-Ingelheim, Ridgefield, CT.

References for breastfeeding information

  1. "Product Information. Combivent (albuterol-ipratropium)." Boehringer-Ingelheim, Ridgefield, CT.

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