Iopamidol Pregnancy and Breastfeeding Warnings
Brand names: Iopamidol-370, Isovue-128, Isovue-200, Isovue-250, Isovue-300, Isovue-370, Isovue-M-200, Isovue-M-300
Medically reviewed by Drugs.com. Last updated on Apr 1, 2024.
Iopamidol Pregnancy Warnings
Use is not recommended unless clearly needed.
AU TGA pregnancy category: Not assigned
US FDA pregnancy category: B
Comments: X-ray examination of women should be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy.
It is not known whether this drug crosses the placental barrier or reaches fetal tissues. However, many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissues. Intravenously administration does not induce adverse effects on fertility and general reproductive performance in rats. No teratogenic effects attributable to this drug have been observed in teratology studies performed in animals. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are no adequate and well controlled studies in pregnant women.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Iopamidol Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
Animal experiences revealed that this drug is nontoxic in animals after oral administration. Due to the low level of absorption of this drug from the gastrointestinal tract, it is unlikely that a fetus could be exposed to significant levels. Harm to the nursing infant is unlikely to occur.
See also
References for pregnancy information
- Zhanel GG, Mayer M, Laing N, Adam HJ (2006) "Mutant Prevention Concentrations of Levofloxacin Alone and in Combination with Azithromycin, Ceftazidime, Colistin (Polymyxin E), Meropenem, Piperacillin-Tazobactam, and Tobramycin against Pseudomonas aeruginosa." Antimicrob Agents Chemother, 50, p. 2228-30
- (2007) "Product Information. Isovue-M-200 (iopamidol)." Bracco Diagnostics Inc
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2007) "Product Information. Isovue-M-200 (iopamidol)." Bracco Diagnostics Inc
- Cerner Multum, Inc. "Australian Product Information."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
