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Generic Name
Ibuprofen and Codeine phosphate
Trade Name
Codafen continus
Manufacturer
Mundipharma
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.
The risk category for Ibuprofen is B if not used in 3rd trimester.
The risk category for Ibuprofen is D if used in 3rd trimester.
FDA Pregnancy Risk Categories

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Indication
Indication
  • analgesic non-steroidal.
  • Anti-inflammatory agent with narcotic analgesic.
  • Fetal Risk
    Fetal Risk
  • No adequata human data for Ibuprofen in 1st trimester but reported doubtful association with some congenital anomalies (anencephaly, cerebral palsy, microphthalmia, nasal 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">cleft and tooth staining) and fetal death. If used in third trimester it causes constriction of pulmonary artery to aorta">ductus arteriosus with subsequent neonatal pulmonary hypertension. It causes oligohydramnios.
  • No well – controlled data for codeine but suggested possible association with respiratory, genitourinary malformations, down’s syndrome, umbilical and inguinal hernias, pyloric stenosis and hydrocephaly.
  • For opiates in general, suggested to produce 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">cleft lip/palate, heart, musculoskeletal , gastrointestinal malformations and inguinal hernias.
  • High doses of codeine at term cause neonatal withdrawal and respiratory depression.
  • Breast Feeding
    Breast Feeding
  • Codeine and Ibuprofen are excreted into milk both safe in breast feeding.
  • 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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