Europe — EMA
Humulin I (Isophane)
Humulin I (Isophane) is a recombinant human insulin for subcutaneous use in type 1 and type 2 diabetes; see its mechanism, uses, safety and interactions.
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What is Insulin Human (Rdna)?
Humulin I (Isophane) is a recombinant human insulin (rDNA) formulated as an injectable solution for subcutaneous administration. It is supplied in the European market as an intermediate‑acting insulin without a specified strength in this description. The product is prescription‑only and belongs to the antidiabetic drug class. It is used to replace or supplement insulin in patients with diabetes mellitus, helping to maintain glycemic control as part of a treatment plan.
What is Insulin Human (Rdna) used for?
Humulin I (Isophane) is indicated for the management of blood glucose in adults and children with diabetes mellitus.
- Type 1 diabetes mellitus as part of basal insulin therapy. - Type 2 diabetes mellitus when combined with oral agents or other insulins. - Adjunct to meal‑time rapid‑acting insulin to provide basal coverage. - Use during pregnancy only when benefits outweigh risks, under specialist supervision. - May be employed in insulin‑pump therapy where intermediate‑acting insulin is required. - For patients who have difficulty adhering to multiple daily injections, Humulin I can reduce injection frequency by providing a once‑or twice‑daily basal dose.
What are the side effects of Insulin Human (Rdna)?
Adverse reactions to Humulin I may vary in frequency and severity, ranging from mild injection‑site symptoms to rare systemic events.
Common: - Mild hypoglycemia, especially if meals are delayed or carbohydrate intake is insufficient. - Redness, swelling, or itching at the injection site. - Lipodystrophy presenting as localized thickening or loss of subcutaneous fat. - Transient weight gain due to fluid retention.
Serious: - Severe hypoglycemia with neuroglycopenic symptoms such as confusion, seizures, or loss of consciousness. - Allergic reactions including urticaria, angioedema, or anaphylaxis. - Persistent hyperglycemia indicating possible insulin resistance or dosing error.
What precautions apply to Insulin Human (Rdna)?
When prescribing Humulin I, clinicians should evaluate patient‑specific factors and monitor for conditions that may alter insulin requirements or increase risk of adverse events.
- Assess renal and hepatic function, as impairment can prolong insulin action. - Review history of hypoglycemia unawareness and adjust dosing accordingly. - Counsel patients on proper injection technique and rotation of sites to prevent lipodystrophy. - Advise regular blood glucose monitoring, especially during illness, stress, or changes in physical activity. - Consider pregnancy status; insulin is the preferred agent but dosing may need adjustment. - Evaluate concomitant use of beta‑blockers, which may mask hypoglycemia symptoms.
What does Insulin Human (Rdna) interact with?
Humulin I can interact with other medications that affect glucose metabolism or insulin pharmacodynamics, requiring dose adjustments or heightened monitoring.
Avoid: - Concurrent use of other rapid‑acting insulins without appropriate dose reduction, which may cause severe hypoglycemia. - Combination with meglitinides (e.g., repaglinide, nateglinide) that also stimulate insulin release, increasing hypoglycemia risk.
Use with caution: - Beta‑blockers may blunt adrenergic warning signs of hypoglycemia. - Corticosteroids can raise blood glucose, potentially necessitating higher insulin doses. - Diuretics, especially thiazides, may impair glucose tolerance. - Oral antidiabetic agents such as sulfonylureas may have additive hypoglycemic effects.
Frequently asked questions
What type of insulin is Humulin I (Isophane) and how does it differ from rapid‑acting insulins?+
Can Humulin I be used in both type 1 and type 2 diabetes patients?+
How should Humulin I be administered to ensure proper absorption?+
What are the signs of mild hypoglycemia that patients on Humulin I should watch for?+
When is severe hypoglycemia considered an emergency with Humulin I therapy?+
Is it safe to use Humulin I during pregnancy?+
How do beta‑blockers affect the safety profile of Humulin I?+
What monitoring is recommended when starting Humulin I therapy?+
Can Humulin I be combined with oral antidiabetic agents?+
What should a patient do if they experience an allergic reaction to Humulin I?+
Is there a need for dose adjustment of Humulin I in patients with kidney disease?+
How does Humulin I interact with corticosteroid therapy?+
Product details
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