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Gentamicin ophthalmic Pregnancy and Breastfeeding Warnings

Gentamicin ophthalmic is also known as: Garamycin Ophthalmic, Genoptic, Gentacidin, Gentak, Gentasol, Ocu-Mycin

Medically reviewed by Drugs.com. Last updated on Aug 29, 2018.

Gentamicin ophthalmic Pregnancy Warnings

Animal studies have revealed evidence of decreased body weights, kidney weights, and medial glomerular counts in pups after maternal exposure to daily ophthalmic doses 500 times the maximum recommended human dose. Evidence of (probably reversible) damage to immature nephrons of the fetal kidney associated with use, and eighth cranial nerve damage associated with aminoglycoside exposure in utero have been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: There are no adequate data available on use of this formulation in pregnant women to inform a drug-related risk.

Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts state that aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Gentamicin ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The WHO considers this drug compatible with breastfeeding.
-Some experts state that eye drop formulations present little risk to the nursing infant.
-Systemically circulating levels of this drug may be decreased by placing pressure over the tear duct in the corner of the eye over at least 1 minute; excess solution should be removed with tissues.

See references

References for pregnancy information

  1. "Product Information. Garamycin (gentamicin ophthalmic)." Schering Corporation, Kenilworth, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Garamycin (gentamicin ophthalmic)." Schering Corporation, Kenilworth, NJ.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  7. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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