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Pancrelipase Pregnancy and Breastfeeding Warnings

Pancrelipase is also known as: Cotazym, Cotazym-S, Creon, Ku-Zyme HP, Lipram, Lipram UL, Panase, Pancrease, Pancrease MT, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancreaze, Pancrecarb MS, Pertzye, Protilase, Protilase MT-16, Ultrase MT 20, Ultresa, Vio-Moore, Viokace, Viokase, Zenpep, Zymase

Medically reviewed on Aug 6, 2018

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: C

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

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 references

References for pregnancy information

  1. "Product Information. Ultrase MT (pancrelipase)." Scandipharm Inc, Birmingham, AL.
  2. "Product Information. Creon 20 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  3. "Product Information. Viokase (pancrelipase)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. "Product Information. Cotazym (pancrelipase)." Organon, West Orange, NJ.
  5. "Product Information. Pancrease MT (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.
  6. "Product Information. Creon 5 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  7. "Product Information. Ku-zyme (pancrelipase)." Schwarz Pharma, Mequon, WI.
  8. "Product Information. Creon 10 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  9. "Product Information. Cotazym-S (pancrelipase)." Organon, West Orange, NJ.
  10. "Product Information. Zymase (pancrelipase)." Organon, West Orange, NJ.
  11. Cerner Multum, Inc. "Australian Product Information." O 0
  12. "Product Information. Pancrease (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.

References for breastfeeding information

  1. "Product Information. Pancrease MT (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.
  2. "Product Information. Cotazym (pancrelipase)." Organon, West Orange, NJ.
  3. "Product Information. Creon 5 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  4. "Product Information. Ku-zyme (pancrelipase)." Schwarz Pharma, Mequon, WI.
  5. "Product Information. Cotazym-S (pancrelipase)." Organon, West Orange, NJ.
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. "Product Information. Zymase (pancrelipase)." Organon, West Orange, NJ.
  8. "Product Information. Pancrease (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.
  9. "Product Information. Creon 10 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  10. "Product Information. Ultrase MT (pancrelipase)." Scandipharm Inc, Birmingham, AL.
  11. "Product Information. Creon 20 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
  12. "Product Information. Viokase (pancrelipase)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

Further information

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

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