Europe — EMA
Humulin I (Isophane)
Humulin I (Isophane) is an intermediate‑acting recombinant human insulin for Type 1 and Type 2 diabetes; see uses, mechanism, side effects, and precautions.
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What is 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.
What is Insulin Human (Rdna) used for?
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.
What are the side effects of Insulin Human (Rdna)?
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).
What precautions apply to Insulin Human (Rdna)?
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.
What does Insulin Human (Rdna) interact with?
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
What type of insulin is Humulin I (Isophane)?+
How is Humulin I administered?+
For which diabetes conditions is Humulin I prescribed?+
How does Humulin I differ from rapid‑acting insulin?+
What are the most common side effects of Humulin I?+
When should a patient seek medical attention for a reaction to Humulin I?+
Can Humulin I be used during pregnancy?+
How should injection sites be rotated with Humulin I?+
What factors may require dose adjustment of Humulin I?+
Which medications should be avoided while taking Humulin I?+
How does alcohol affect Humulin I therapy?+
What monitoring is recommended while on Humulin I?+
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