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 for subcutaneous administration. The product contains insulin human (rDNA) in a premixed formulation, with the exact strength not specified on the label. It is marketed in the European Union as a prescription‑only antidiabetic agent used to manage blood glucose levels in patients with diabetes mellitus and is intended for use under medical supervision.

Manufacturer / TM Owner

Eli Lilly Nederland B.V.

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Indications & Clinical Uses

Humulin I (Isophane) is indicated for the treatment of diabetes mellitus when basal insulin coverage is required.

  • Type 1 diabetes mellitus in adults and children.
  • Type 2 diabetes mellitus as part of a basal insulin regimen.
  • Adjunct therapy when oral antidiabetic agents are insufficient.
  • Use in patients requiring a long‑acting insulin to maintain fasting glucose control.
  • May be combined with rapid‑acting insulin for flexible dosing.

How It Works

  • Humulin I (Isophane) contains protamine‑crystallized human insulin that forms a subcutaneous depot, releasing insulin slowly over time. The insulin molecules bind to insulin receptors on muscle and adipose tissue, activating the receptor’s tyrosine kinase activity, which promotes translocation of GLUT‑4 transporters and enhances glucose uptake. In the liver, receptor activation suppresses gluconeogenesis, thereby lowering circulating glucose concentrations and improves overall metabolic control.

Side Effects

Adverse reactions reported with Humulin I (Isophane) are generally related to its insulin activity and formulation components.

Common

  • Hypoglycemia, especially if meals are missed or dosing is excessive.
  • Injection site reactions such as redness, swelling, or itching.
  • Lipodystrophy at the injection site.
  • Weight gain associated with improved glycemic control.
  • Transient blurred vision due to rapid glucose changes.
  • Nausea or abdominal discomfort after injection.
  • Mild headache or dizziness during dose adjustments.

Serious

  • Severe hypoglycemia with neuroglycopenic symptoms.
  • Allergic reactions including urticaria, angioedema, or anaphylaxis.
  • Lipohypertrophy leading to erratic insulin absorption.
  • Edema or heart failure exacerbation in susceptible patients.
  • Hypersensitivity leading to serum sickness‑like reaction.

Precautions & Warnings

When prescribing Humulin I (Isophane), clinicians should consider several precautions to minimize risks and ensure safe use.

  • Assess renal and hepatic function before initiating therapy, as impairment may alter insulin clearance.
  • Monitor blood glucose closely during periods of illness, stress, or changes in physical activity.
  • Adjust dose in pregnant or lactating women, recognizing altered insulin requirements.
  • Use caution in patients with a history of severe hypoglycemia or unawareness of symptoms.
  • Inspect injection sites regularly for lipodystrophy or infection.
  • Evaluate cardiovascular status in patients with heart failure, as fluid retention may worsen symptoms.

Avoid Interactions

Humulin I (Isophane) may interact with other medicines that affect glucose metabolism or insulin action.

Avoid

  • Concurrent use of other rapid‑acting insulins without dose adjustment, which can cause severe hypoglycemia.
  • Combination with sulfonylureas or meglitinides without careful monitoring, increasing hypoglycemia risk.
  • Concurrent use of meglitinides with overlapping action profiles may cause additive hypoglycemia.

Use with caution

  • Beta‑blockers, which may mask hypoglycemia symptoms.
  • Corticosteroids, which can raise blood glucose and require insulin dose increase.
  • Diuretics, especially thiazides, that may affect potassium levels and glucose control.
  • ACE inhibitors or ARBs, which may potentiate insulin’s antihyperglycemic effect.
  • Thyroid hormones, which can accelerate insulin metabolism and alter glycemic control.

Frequently Asked Questions

Humulin I (Isophane) is a recombinant human insulin (isophane) formulated as a protamine‑crystallized injectable suspension that provides prolonged basal insulin action after subcutaneous injection.

It is prescribed for adults and children with type 1 diabetes and for adults with type 2 diabetes who need basal insulin support, either alone or in combination with other antidiabetic agents.

Humulin I (Isophane) contains protamine that slows absorption, creating a long‑acting basal profile, whereas rapid‑acting insulins lack protamine and act within minutes to control post‑prandial glucose spikes.

Humulin I (Isophane) is classified as pregnancy category B in the EU, indicating that animal studies have not shown risk, but it should be used only if clearly needed and under medical supervision.

Common signs include sweating, trembling, hunger, confusion, blurred vision, and in severe cases, loss of consciousness or seizures. Patients should monitor blood glucose regularly and have a source of fast‑acting carbohydrate available.

Unopened vials should be stored in a refrigerator (2‑8 °C). After opening, the suspension can be kept at room temperature (up to 30 °C) for a limited period, usually 28 days, as specified by the manufacturer.

Subcutaneous injection is recommended in the abdomen, thigh, or upper outer arm. Rotating injection sites helps reduce the risk of lipodystrophy and maintains consistent absorption.

When transitioning, clinicians should assess the previous insulin’s potency and duration, adjust the dose gradually, and monitor glucose closely to avoid hypo‑ or hyperglycemia.

Routine monitoring includes fasting and post‑prandial blood glucose, HbA1c every 3‑6 months, renal and hepatic function tests, and periodic assessment of lipid profiles and cardiovascular status.

Yes, it can be combined with oral agents such as metformin, but dose adjustments and close glucose monitoring are required to minimize the risk of hypoglycemia.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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