Pancrelipase Pregnancy and Breastfeeding Warnings
Brand names: Cotazym, Cotazym-S, Creon, Ku-Zyme HP, Lapase, Lipram UL, Panase, Pancrease, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancreaze, Pancrecarb MS, Pertzye, Protilase, Protilase MT-16, Ultrase, Ultrase MT 20, Ultresa, Vio-Moore, Viokace, Viokase, Zenpep, Zymase
Medically reviewed by Drugs.com. Last updated on Jul 5, 2022.
Pancrelipase Pregnancy Warnings
This drug should be used during pregnancy 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: Malformative risk with use of this drug in pregnant women is unlikely due to minimal systemic absorption.
Comments:
-Patients with exocrine pancreatic insufficiency should receive adequate nutritional support (including adequate caloric intake) during pregnancy to ensure normal maternal weight gain and fetal growth.
-Some experts recommend: This drug should be used in doses sufficient to provide adequate effects.
Animal studies have not been reported. Fetal harm and the effects on reproductive capacity are unknown. 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.
Pancrelipase Breastfeeding Warnings
Caution is recommended; benefit to mother should outweigh risk to the infant.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Some experts recommend: This drug should be used in doses sufficient to provide adequate effects to the mother.
See also
References for pregnancy information
- Product Information. Viokase (pancrelipase). Wyeth-Ayerst Laboratories. 2001;PROD.
- Product Information. Ku-Zyme (pancrelipase). Schwarz Pharma. 2022.
- Product Information. Zymase (pancrelipase). Organon. 2001;PROD.
- Product Information. Cotazym (pancrelipase). Organon. 2001;PROD.
- Product Information. Cotazym-S (pancrelipase). Organon. 2001;PROD.
- Product Information. Pancrease (pancrelipase). McNeil Pharmaceutical. 2001;PROD.
- Product Information. Pancrease (pancrelipase). Apothecon Inc. 2022.
- Product Information. Ultrase MT 12 (pancrelipase). Scandipharm Inc. PROD.
- Product Information. Creon 5 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- Product Information. Creon 10 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- Product Information. Creon 20 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Viokase (pancrelipase). Wyeth-Ayerst Laboratories. 2001;PROD.
- Product Information. Ku-Zyme (pancrelipase). Schwarz Pharma. 2022.
- Product Information. Zymase (pancrelipase). Organon. 2001;PROD.
- Product Information. Cotazym (pancrelipase). Organon. 2001;PROD.
- Product Information. Cotazym-S (pancrelipase). Organon. 2001;PROD.
- Product Information. Pancrease (pancrelipase). McNeil Pharmaceutical. 2001;PROD.
- Product Information. Pancrease (pancrelipase). Apothecon Inc. 2022.
- Product Information. Ultrase MT 12 (pancrelipase). Scandipharm Inc. PROD.
- Product Information. Creon 5 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- Product Information. Creon 10 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- Product Information. Creon 20 (pancrelipase). Solvay Pharmaceuticals Inc. 2001;PROD.
- 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.
