Product image of Humulin I (Isophane) (Insulin Human (Rdna)) supplied by GNH India

Humulin I (Isophane)

Active Ingredient:
Insulin Human (Rdna)
Origin:
EU

Humulin I (Isophane) (Insulin Human (Rdna))

Humulin I (Isophane) is a recombinant human insulin (isophane) supplied as an injectable suspension. It is a prescription‑only product marketed in the European Union. The formulation contains insulin human (isophane) in a suspension intended for intramuscular or subcutaneous administration. Humulin I is used as a basal insulin to provide prolonged glucose‑lowering action in patients with diabetes. It is classified under ATC code A10AB01 and belongs to the antidiabetic drug class.

Manufacturer / TM Owner

Eli Lilly Nederland B.V.

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Indications & Clinical Uses

Humulin I (isophane) is indicated for the long‑acting insulin needs of adults with diabetes.

  • Type 1 diabetes mellitus as part of a basal insulin regimen.
  • Type 2 diabetes mellitus when basal insulin is required.
  • Adjunct to rapid‑acting insulin analogues for basal‑bolus therapy.
  • Use in patients who need a steady insulin level over 24 hours.
  • May be employed when oral antidiabetic agents are insufficient.

How It Works

  • Humulin I contains recombinant human insulin (isophane) that binds to insulin receptors on muscle, adipose and hepatic cells. Receptor activation triggers autophosphorylation and downstream signaling through the PI3‑kinase/Akt pathway, promoting translocation of GLUT‑4 transporters to the cell membrane and increasing glucose uptake. In the liver, it suppresses gluconeogenesis and glycogenolysis, resulting in reduced plasma glucose concentrations. The prolonged suspension formulation releases insulin slowly, providing basal coverage for up to 24 hours.

Side Effects

Adverse reactions to Humulin I may vary in frequency and severity.

Common

  • Mild hypoglycemia (low blood sugar).
  • Injection site redness or swelling.
  • Lipodystrophy at the injection site.
  • Weight gain.
  • Transient headache.

Serious

  • Severe hypoglycemia with neuroglycopenic symptoms.
  • Allergic reactions such as urticaria or angioedema.
  • Anaphylactic hypersensitivity.
  • Persistent edema or exacerbation of heart failure.

Precautions & Warnings

Before initiating Humulin I, clinicians should evaluate several safety considerations.

  • Assess renal and hepatic function, as impairment can alter insulin clearance.
  • Review history of hypoglycemia unawareness or severe episodes.
  • Adjust doses when patients are pregnant, lactating, or planning pregnancy; data are limited.
  • Monitor for signs of cardiovascular disease, especially in patients with edema.
  • Caution in patients using beta‑blockers, which may mask hypoglycemia symptoms.
  • Avoid use in individuals with known hypersensitivity to recombinant human insulin.

Avoid Interactions

Humulin I can interact with other medicines that affect blood glucose or insulin action.

Avoid

  • Concomitant use of other insulin products without dose adjustment.
  • Co‑administration with sulfonylureas or meglitinides, which may increase hypoglycemia risk.

Use with caution

  • Beta‑adrenergic blockers, which can mask hypoglycemia signs.
  • Oral corticosteroids, which may raise glucose levels.
  • Thiazide diuretics, which can reduce insulin sensitivity.
  • Alcohol, which can cause delayed hypoglycemia.

Frequently Asked Questions

Humulin I (Isophane) is a recombinant human insulin formulated as an intermediate‑acting suspension (isophane) used for basal glucose control.

Humulin I is administered by subcutaneous or intramuscular injection, typically once or twice daily depending on the patient’s regimen.

Humulin I is indicated for both type 1 and type 2 diabetes mellitus when a long‑acting basal insulin is required.

Yes, Humulin I is often combined with rapid‑acting insulin analogues in a basal‑bolus regimen to provide both steady and mealtime glucose control.

Common adverse effects include mild hypoglycemia, injection‑site redness or swelling, lipodystrophy, weight gain, and occasional headache.

Serious reactions can include severe hypoglycemia, allergic responses such as urticaria or angioedema, anaphylaxis, and worsening edema or heart‑failure symptoms.

Patients with renal impairment should be monitored closely because reduced kidney function can decrease insulin clearance and increase hypoglycemia risk.

Alcohol can delay the onset of hypoglycemia and mask its symptoms, so patients should consume alcohol cautiously while using Humulin I.

Concurrent use of other insulin products without dose adjustment and the combination with sulfonylureas or meglitinides should be avoided due to heightened hypoglycemia risk.

Beta‑blockers, corticosteroids, thiazide diuretics, and other agents that affect glucose metabolism should be used with caution and may require insulin dose adjustments.

Pregnancy safety data are limited; clinicians should weigh potential benefits against risks and monitor glucose closely if Humulin I is used during pregnancy.

Humulin I is classified under ATC code A10AB01, which denotes human insulin (isophane) in the antidiabetic therapeutic group.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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