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Iohexol Pregnancy and Breastfeeding Warnings

Brand names: Myelo-Kit, Omnipaque 12, Omnipaque 140, Omnipaque 180, Omnipaque 180 Redi-Unit, Omnipaque 210, Omnipaque 240, Omnipaque 240 Redi-Unit, Omnipaque 300, Omnipaque 350, Omnipaque 9, Omnipaque Flexipak, Oraltag

Iohexol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Use for hysterosalpingography during pregnancy is contraindicated.

US FDA pregnancy category: Not assigned

Risk Summary:
- Hysterosalpingography is contraindicated in pregnant women or for those where pregnancy is suspected due to the potential risk to the fetus from an intrauterine procedure.

Comments:
-There is no data on use in pregnant women to know any drug associated risks. This drug crosses the placenta and small amounts may reach fetal tissues.

This drug was not embryotoxic nor teratogenic in either rats or rabbits when administered intravenously at doses up to 0.4 (rats) and 0.5 (rabbits) times the maximum recommended human dose. There are no controlled data in human pregnancy.

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.

See references

Iohexol Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Bottle feedings may be substituted for breast feedings for 24 hours following administration of this drug; however, some experts feel that breast feeding may be continued normally when iodinated contrast media are given to the mother.
-The effects in the nursing infant are unknown.

Contrast media are poorly excreted in human breast milk and minimal amounts are absorbed by the intestine. Approximately 0.5% of the weight adjusted maternal dose is excreted in breast milk during 24 hours after injection of this drug. The amount ingested by the baby in the first 24 hours after injection corresponds to only 0.2% of the pediatric dose.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Omnipaque 180 (iohexol). Amersham Health. 2007.
  3. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Omnipaque 180 (iohexol). Amersham Health. 2007.
  3. 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.