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Generic Name
Gentamycin and Prednisolone acetate
Trade Name
Apigent - P
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 is B for Prednisolone.
The risk category is C for Gentamycin.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Local treatment of ocular infection.
  • Fetal Risk
    Fetal Risk
  • Gentamycin causes fetal nephrotoxicity in animals.
  • No adequate human data but when used in combination with prednisolone reported to cause fetal renal cystic dysplasia.
  • In animals cortico steroids cause anomalies especially 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 palate.
  • No well controlled human data but reported possible association with growth retardation, malformations (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 palate), cataract, and fetal adrenal suppression when used through pregnancy.
  • No data available for topical use of both drugs.
  • Breast Feeding
    Breast Feeding
  • Predrisolone is safe in breast feeding.
  • Gentamycin is excreted in to milk in very small amounts.
  • Possible cause of infant's bloody diarrhea.
  • No data for topical use of the drug.
  • 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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