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Sodium acetate Pregnancy and Breastfeeding Warnings

Sodium acetate Pregnancy Warnings

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

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Although sodium is a natural constituent of tissues and fluids, high levels can lead to dehydration.
-Monitor sodium as well as serum potassium and pH if used in pregnancy, as the acetate ion can cause hyperkalemia or metabolic acidosis.

Animal studies have not been performed. There are no controlled data in human pregnancy.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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

Sodium acetate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

See references

See also

References for pregnancy information

  1. (2002) "Product Information. Sodium Acetate (sodium acetate)." Hospira Inc
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2002) "Product Information. Sodium Acetate (sodium acetate)." Hospira Inc

Further information

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

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