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Generic Name
Theophylline and Salbutamol (albuterol)
Trade Name
Perventil Elixir
Manufacturer
Malesci
Risk Category
C
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
FDA Pregnancy Risk Categories

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Indication
Indication
  • bronchial smooth muscle">bronchodilator with β adrenergic agent for treatment of bronchial asthma.
  • Fetal Risk
    Fetal Risk
  • No adequate human data for theophylline reported possible association with cardiovascular defects oral cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">clefts and spina bifida in 1st trimester exposure.
  • It also causes neonatal tachycardia, vomiting, irritability if used near term or at high doses. With prolonged chronic use may cause neonatal with drawal.
  • Reported association between the use of salbutamol in animals and increased incidence of cleft palate and cranioschisis.
  • Limited human data but suggested possible association with polydactyly in 1st trimester exposure.
  • Therapeutic doses of the drug by inhalation have no effect on maternal and fetal hemodynamics, but high repeated doses may cause fetal tachycardia.
  • Use of β sympathomimetics including Salbutamol may cause retinopathy in premature infants.
  • Breast Feeding
    Breast Feeding
  • Theophylline is excreted in milk. Safe in breast feeding, may cause irritability in nursing infants.
  • No data available for Salbutamol but other β sympathomimetics are considered safe.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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