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Insulin isophane Pregnancy and Breastfeeding Warnings

Insulin isophane is also known as: Humulin N, Humulin N Pen, Iletin II NPH Pork, Iletin NPH, Insulin Purified NPH Pork, NPH Insulin, Novolin N, Novolin N Innolet, Novolin N PenFill, Relion Novolin N

Medically reviewed on Aug 17, 2018

Insulin isophane Pregnancy Warnings

Pregnancies complicated by hypoglycemia and hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. 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.

Use is considered acceptable

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

Comment: Good glycemic control is essential for patients with diabetes or a history of gestational diabetes before conception and throughout pregnancy.

See references

Insulin isophane Breastfeeding Warnings

Use is considered acceptable

Excreted into human milk: Yes

Breast-feeding mothers may require adjustments in insulin dose.

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 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 and 0.56 units/kg, respectively in breastfeeding women compared to 0.33 and 0.75 units/kg per day in similar women who did not breastfeed.

See references

References for pregnancy information

  1. "Product Information. Humulin N (insulin isophane)." Lilly, Eli and Company, Indianapolis, IN.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. 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
  5. "Product Information. NovoLIN N (insulin isophane (NPH))." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  6. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. 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 -]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Humulin N (insulin isophane)." Lilly, Eli and Company, Indianapolis, IN.

Further information

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

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