Europe — EMA
Humulin R (Regolare)
Humulin R (human insulin) is a rapid‑acting injectable solution for type 1 and type 2 diabetes, covering its mechanism, uses, side effects, and precautions.
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What is Insulin Human (Rdna)?
Humulin R (Regolare) is a human insulin (Rdna) injectable solution supplied at a strength of 100 IU/mL. It is a prescription‑only medication marketed in the European Union for subcutaneous administration to help regulate blood glucose in people with diabetes. The formulation contains recombinant DNA‑derived insulin identical to endogenous human insulin, providing rapid onset of action after injection. It is stored in a vial and must be kept refrigerated until use.
What is Insulin Human (Rdna) used for?
Humulin R is indicated for the management of hyperglycaemia in adults and children with diabetes mellitus.
- Initiation of basal‑bolus insulin therapy in type 1 diabetes, typically combined with carbohydrate counting. - Supplemental rapid‑acting insulin for mealtime glucose control in type 2 diabetes, often used when oral agents are insufficient. - Adjustment of insulin dose during periods of illness, stress, or changes in diet, guided by frequent blood‑glucose monitoring. - Use in hospital or outpatient settings where a short‑acting insulin is required for intravenous or subcutaneous administration. - Replacement therapy when endogenous insulin production is insufficient, such as after pancreatectomy or in advanced diabetes.
What are the side effects of Insulin Human (Rdna)?
Adverse reactions to Humulin R may vary in frequency and severity.
Common: - Hypoglycaemia, manifested by sweating, tremor, or confusion. - Injection‑site reactions such as redness, swelling, or itching. - Lipodystrophy, including lipohypertrophy at repeated injection sites. - Mild weight gain associated with improved glycaemic control. - Nausea or abdominal discomfort reported occasionally. - Transient visual disturbances such as blurred vision during rapid glucose shifts.
Serious: - Severe hypoglycaemia leading to loss of consciousness or seizures. - Allergic reactions ranging from urticaria to anaphylaxis. - Edema or heart failure exacerbation in susceptible patients. - Persistent hyperglycaemia indicating possible insulin resistance. - Severe allergic response presenting as angio‑edema of the face, lips, or tongue. - Acute pancreatitis manifested by upper abdominal pain and elevated enzymes.
What precautions apply to Insulin Human (Rdna)?
When prescribing Humulin R, clinicians should consider several precautionary measures to minimise risks and optimise therapy.
- Assess renal and hepatic function, as impairment may alter insulin clearance. - Adjust dose in patients with fluctuating dietary intake or physical activity. - Monitor for hypoglycaemia in elderly, pregnant, or fasting individuals. - Educate patients on proper injection technique to avoid lipohypertrophy. - Review concomitant medications that may potentiate or mask hypoglycaemia. - Use caution in patients with a history of cardiovascular disease or heart failure. - Store the product according to label instructions; avoid freezing.
What does Insulin Human (Rdna) interact with?
Humulin R may interact with other agents that affect glucose metabolism or insulin action.
Avoid: - Concurrent use of high‑dose sulfonylureas that can precipitate severe hypoglycaemia. - Administration of glucagon or beta‑agonists during an insulin overdose. - Mixing Humulin R with other insulin formulations not specifically approved for co‑administration. - Use of MAO inhibitors is not recommended as they may interfere with insulin metabolism.
Use with caution: - Beta‑blockers, which may mask hypoglycaemic symptoms. - Corticosteroids, which can increase insulin resistance and require dose adjustments. - Diuretics, especially thiazides, that may elevate blood glucose. - Oral antidiabetic agents such as metformin, where combined therapy necessitates close monitoring. - Alcohol consumption can potentiate insulin’s glucose‑lowering effect and increase hypoglycaemia risk.
Frequently asked questions
What is the strength of Humulin R and how is it supplied?+
Can Humulin R be used in both type 1 and type 2 diabetes?+
How does Humulin R differ from long‑acting insulin preparations?+
What route of administration is recommended for Humulin R?+
What are the most common side effects of Humulin R?+
When should a patient seek medical attention for hypoglycaemia while using Humulin R?+
Are there any special storage requirements for Humulin R?+
How does renal impairment affect the use of Humulin R?+
Can Humulin R be mixed with other insulin types in the same syringe?+
What medications should be avoided or used with caution when a patient is on Humulin R?+
Is Humulin R safe to use during pregnancy?+
What monitoring is required for patients on Humulin R therapy?+
Product details
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