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Insulin regular Pregnancy and Breastfeeding Warnings

Insulin regular is also known as: Humulin R, Humulin R U-500 (Concentrated), Humulin R U-500 KwikPen, Iletin II Regular Pork, Iletin Regular, Novolin R, Novolin R Innolet, Novolin R PenFill, ReliOn/Humulin R, ReliOn/Novolin R, Velosulin BR

Medically reviewed on June 23, 2016

Insulin regular Pregnancy Warnings

Use is considered acceptable

AU TGA pregnancy category: Not Assigned
US FDA pregnancy category: B

Comment: It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy.

Pregnancies complicated by hypoglycemia and hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.

AU TGA pregnancy category: Not assigned; this class of drugs is generally exempt from pregnancy classification.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Insulin regular Breastfeeding Warnings

Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken by mouth. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as in mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production. In a small well controlled study in breastfeeding women with type 1 diabetes using continuous subcutaneous insulin infusion, basal and total daily insulin requirements were found to be 0.21 units/kg and 0.56 units/kg , respectively compared to 0.33 units/kg and 0.75 units/kg per day in similar women who did not breastfeed.

Use is considered acceptable

Excreted into human milk: Yes

Breast-feeding mothers may require adjustments in insulin dose.

See references

References for pregnancy information

  1. Blumer I, Hadar E, Hadden DR, et.al "Diabetes and pregnancy: an endocrine society clinical practice guideline." J Clin Endocrinol Metab 98 (2013): 2013-465
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Humulin R (insulin regular)." Lilly, Eli and Company, Indianapolis, IN.
  5. "Product Information. NovoLIN R (insulin regular)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. NovoLIN R (insulin regular)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. "Product Information. Humulin R (insulin regular)." Lilly, Eli and Company, Indianapolis, IN.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  5. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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