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

Humulin I (Isophane)

Active Ingredient:
Insulin Human
Origin:
EU

Humulin I (Isophane) (Insulin Human)

Humulin I (Isophane) is an insulin product whose active ingredient is insulin human (isophane). It is supplied as an injectable solution for subcutaneous administration. The formulation provides a protamine‑combined, intermediate‑acting insulin preparation; the specific strength is not listed in the available data. Humulin I is marketed in the European Union, belongs to the insulin drug class, and is used to help control blood glucose levels in diabetes.

Manufacturer / TM Owner

Eli Lilly Nederland B.V.

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Indications & Clinical Uses

Humulin I (Isophane) is indicated for the management of hyperglycemia in patients with diabetes mellitus. It is used as part of a comprehensive diabetes treatment plan that may include diet, exercise, and other glucose‑lowering agents.

  • Type 1 diabetes mellitus requiring basal insulin coverage.
  • Type 2 diabetes mellitus when basal insulin is indicated.
  • Adjunct therapy in patients transitioning from short‑acting insulin regimens.
  • Use in combination with rapid‑acting insulin analogues for basal‑bolus therapy.
  • Situations where a steady, intermediate‑acting insulin profile is preferred.

How It Works

  • Humulin I (Isophane) contains insulin human that binds to insulin receptors on muscle, adipose, and hepatic cells. Receptor activation triggers the tyrosine kinase pathway, promoting translocation of GLUT‑4 transporters to the cell surface and enhancing glucose uptake. In the liver, the insulin signal suppresses gluconeogenesis and glycogenolysis, reducing endogenous glucose production. The protamine component prolongs absorption, creating an intermediate‑duration insulin effect.

Side Effects

Adverse reactions to Humulin I (Isophane) can vary in frequency and severity. Patients should be aware of both common and potentially serious events.

Common

  • Hypoglycemia, especially if meals are delayed or doses are mismatched.
  • Injection site reactions such as redness, swelling, or itching.
  • Lipodystrophy, including lipoatrophy or lipohypertrophy at the injection site.
  • Weight gain associated with improved glycemic control.
  • Localized bruising or bleeding at the injection site.
  • Localized bruising or bleeding at the injection site.

Serious

  • Severe hypoglycemia leading to loss of consciousness or seizures.
  • Allergic reactions ranging from urticaria to anaphylaxis.
  • Edema or fluid retention, particularly in patients with cardiac or renal disease.
  • Rare cases of insulin antibody formation causing resistance.
  • Hypersensitivity reactions that may progress to serum sickness.

Precautions & Warnings

When prescribing or using Humulin I (Isophane), clinicians and patients should consider several precautionary measures to minimize risks and ensure optimal therapy.

  • Assess renal and hepatic function before initiating therapy and monitor periodically.
  • Adjust doses in patients with fluctuating dietary intake or physical activity.
  • Use caution in pregnant or breastfeeding women; benefits must outweigh potential risks.
  • Avoid use in patients with known hypersensitivity to insulin or protamine.
  • Educate patients on proper injection technique to prevent lipodystrophy.
  • Monitor for signs of hypoglycemia, especially in the elderly or those on concomitant glucose‑lowering drugs.
  • Review concomitant medications that may mask hypoglycemia symptoms.

Avoid Interactions

Humulin I (Isophane) may interact with other agents that affect blood glucose or insulin metabolism. Recognizing these interactions helps to avoid adverse events.

Avoid

  • Concurrent use of other insulin products without dose adjustment.
  • Beta‑blockers that can mask hypoglycemia symptoms.
  • High‑dose corticosteroids that increase insulin resistance.
  • MAO inhibitors, which may alter insulin metabolism.

Use with caution

  • Oral antidiabetic agents such as sulfonylureas or meglitinides, which may potentiate hypoglycemia.
  • ACE inhibitors or ARBs, which can enhance insulin sensitivity.
  • Thyroid hormones, as hyperthyroidism may increase insulin requirements.
  • Alcohol, especially in excess, which can cause unpredictable glucose fluctuations.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) that may affect renal function and insulin clearance.

Frequently Asked Questions

Humulin I (Isophane) is a brand of insulin human formulated with protamine to create an intermediate‑acting, subcutaneous injection. Unlike rapid‑acting insulins, it has a slower onset and longer duration, providing basal insulin coverage.

It is prescribed for both type 1 and type 2 diabetes mellitus when basal insulin supplementation is needed as part of a comprehensive treatment plan.

Protamine binds to insulin molecules, delaying their absorption from the injection site, which extends the insulin’s activity to an intermediate duration of about 12‑18 hours.

Pregnancy safety has not been definitively established; clinicians should weigh potential benefits against risks and follow local prescribing guidelines.

Common side effects include hypoglycemia, injection‑site reactions such as redness or itching, lipodystrophy, weight gain, and occasional bruising at the injection site.

Serious reactions may present as severe hypoglycemia with loss of consciousness, allergic responses like urticaria or anaphylaxis, significant edema, or rare insulin‑antibody formation causing resistance.

Unopened vials should be stored in a refrigerator (2‑8 °C). Once opened, they may be kept at room temperature not exceeding 30 °C for a period specified by the manufacturer, typically up to 28 days.

Elderly patients should be monitored closely for hypoglycemia, have dose adjustments based on renal function, and receive education on recognizing low‑blood‑glucose symptoms, which may be blunted by certain medications.

Avoid combining with other insulins without dose adjustment, beta‑blockers, high‑dose steroids, and MAO inhibitors. Use caution with sulfonylureas, ACE inhibitors, thyroid hormones, alcohol, and NSAIDs.

Patients should follow individualized monitoring schedules, typically checking fasting and pre‑meal glucose levels daily, and more frequently when initiating therapy or adjusting doses.

Long‑term use can lead to the development of insulin antibodies in rare cases, which may reduce insulin effectiveness and require dose adjustments.

Mixing with other insulins is possible only under medical supervision; mixing with non‑insulin agents is generally not recommended due to stability concerns.

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GNH India Pharmaceuticals Limited

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Last updated:

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