Citric acid/magnesium oxide/sodium picosulfate Pregnancy and Breastfeeding Warnings
Brand names: Clenpiq, Prepopik
Medically reviewed by Drugs.com. Last updated on Aug 9, 2023.
Citric acid/magnesium oxide/sodium picosulfate Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: Not assigned.
Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comment: Some experts recommend using caution, especially during the first trimester.
Animal studies have failed to reveal evidence of fetal harm and adverse effects on pre-and postnatal development when given this combination drug in oral doses of up to 2000 mg/kg 2 times a day during organogenesis. Animal studies using high doses of sodium picosulfate have revealed evidence of embryofetal toxicity. 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.
Citric acid/magnesium oxide/sodium picosulfate Breastfeeding Warnings
Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.
Excreted into human milk: Unknown (citric acid, magnesium oxide); Yes (sodium picosulfate)
Excreted into animal milk: Unknown (citric acid, magnesium oxide)
Comments:
-The effects of any of the three drugs alone or in combination in the nursing infant are unknown.
-The US CDC advise women that sodium picosulfate may be taken during breastfeeding, and no special precautions are required.
Women given single and multiple doses of sodium picosulfate 10 mg/day had drug levels (including its active metabolite) that remained below the limit of detection (1 ng/mL) in breastmilk.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2010) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm
- (2022) "Product Information. Prepopik (citric acid/Mg oxide/Na picosulfate)." Ferring Pharmaceuticals Inc
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2022) "Product Information. Prepopik (citric acid/Mg oxide/Na picosulfate)." Ferring Pharmaceuticals Inc
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
