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) formulated as an injectable suspension for subcutaneous use. It is supplied in the European market as a prescription‑only product. The preparation provides intermediate‑acting insulin coverage, helping to regulate blood glucose levels in patients with diabetes. Humulin I contains insulin human (isophane) as the sole active ingredient and is typically administered once or twice daily by injection.

Manufacturer / TM Owner

Eli Lilly Nederland B.V.

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Indications & Clinical Uses

Humulin I (Isophane) is used to improve glycemic control in adults and children with diabetes.

  • Type 1 diabetes mellitus as part of a basal insulin regimen.
  • Type 2 diabetes mellitus when basal insulin is required.
  • Combination therapy with rapid‑acting insulin analogues in a basal‑bolus schedule.
  • Situations where intermediate‑acting insulin provides smoother glucose coverage between meals and overnight.
  • Adjunct to oral antidiabetic agents when those agents alone do not achieve target glucose levels.

How It Works

  • Humulin I (Isophane) consists of recombinant human insulin molecules that form micro‑precipitates after subcutaneous injection. These precipitates release insulin slowly, allowing prolonged activation of insulin receptors on muscle, adipose, and hepatic cells. Receptor binding stimulates the tyrosine kinase pathway, enhancing glucose transporter (GLUT4) translocation and increasing glucose uptake, while simultaneously suppressing hepatic gluconeogenesis. The net effect is a gradual reduction in blood glucose concentrations over several hours.

Side Effects

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

Common

  • Mild to moderate hypoglycemia (low blood glucose).
  • Redness, swelling, or itching at the injection site.
  • Lipohypertrophy or lipoatrophy at injection sites.
  • Transient weight gain.
  • Edema, especially in the lower extremities.
  • Localized rash or urticaria.

Serious

  • Severe hypoglycemia with loss of consciousness or seizures.
  • Anaphylactic reaction, including difficulty breathing or throat swelling.
  • Acute allergic dermatitis or serum‑sickness‑like reaction.
  • Hypokalemia associated with prolonged insulin action.
  • Insulin antibody‑mediated resistance or hyperglycemia.
  • Acute pancreatitis (rare).

Precautions & Warnings

Before initiating Humulin I (Isophane), clinicians should consider several safety considerations.

  • Assess renal and hepatic function, as impairment may prolong insulin action.
  • Review history of hypoglycemia unawareness or frequent low glucose episodes.
  • Adjust doses when patients are pregnant, lactating, or planning pregnancy (category unknown).
  • Monitor for signs of allergic reactions, especially with prior insulin sensitivities.
  • Use caution in patients with cardiovascular disease or edema.
  • Consider potential for weight gain and fluid retention during therapy.
  • Educate patients on proper injection technique and rotation of sites.

Avoid Interactions

Humulin I (Isophane) can interact with other medicines, affecting glucose control or insulin activity.

Avoid

  • Concurrent use of other insulin products without dose adjustment.
  • Beta‑blockers that may mask hypoglycemia symptoms.
  • MAO‑inhibitors or certain antidepressants that can potentiate insulin effects.
  • High‑dose corticosteroids that may cause hyperglycemia requiring dose changes.
  • Oral sulfonylureas or meglitinides that increase risk of hypoglycemia.

Use with caution

  • Thiazide diuretics, which may raise blood glucose levels.
  • ACE inhibitors or ARBs, which can affect renal function and insulin clearance.
  • Antipsychotics (e.g., olanzapine) that may exacerbate hyperglycemia.
  • Alcohol, which can cause delayed hypoglycemia.
  • Exercise, requiring possible insulin dose reduction.

Frequently Asked Questions

Humulin I (Isophane) is an intermediate‑acting recombinant human insulin (isophane) that provides prolonged glucose‑lowering activity.

It is given as a subcutaneous injection, usually in the abdomen, thigh, or upper arm, following the dosing schedule prescribed by a healthcare professional.

Humulin I is indicated for both Type 1 and Type 2 diabetes mellitus when basal insulin coverage is needed.

Humulin I forms a suspension that releases insulin slowly over several hours, whereas rapid‑acting insulins are absorbed quickly to control post‑meal glucose spikes.

Common adverse effects include mild hypoglycemia, injection‑site redness or itching, lipohypertrophy, transient weight gain, edema, and localized rash.

Seek immediate care if signs of severe hypoglycemia, anaphylaxis (e.g., difficulty breathing, swelling of the throat), or unexplained persistent hyperglycemia occur.

The pregnancy category is listed as unknown; clinicians should weigh potential benefits against risks and monitor glucose closely if used during pregnancy.

Rotate injections within the same region (abdomen, thigh, or arm) and avoid using the exact same spot repeatedly to reduce lipohypertrophy.

Renal or hepatic impairment, changes in diet or activity level, concomitant medications that affect glucose, and illness or stress can all necessitate dose changes.

Other insulin products, beta‑blockers that mask hypoglycemia, MAO‑inhibitors, high‑dose steroids, and sulfonylureas or meglitinides should be avoided without dose modification.

Alcohol can cause delayed hypoglycemia, especially when taken on an empty stomach, so patients should monitor blood glucose closely after drinking.

Regular self‑monitoring of blood glucose, periodic HbA1c testing, and routine assessment of renal and hepatic function are advised.

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GNH India Pharmaceuticals Limited

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Last updated:

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