ReliOn / HumuLIN R

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Regular insulin is a short-acting insulin that starts to work within 30 minutes after injection, peaks in 2 to 3 hours, and keeps working for up to 8 hours.

Regular insulin is used to improve blood sugar control in adults and children with diabetes mellitus. This medicine may be used for type 1 or type 2 diabetes.

Regular insulin may also be used for purposes not listed in this medication guide.

You should not use insulin if you are having an episode of hypoglycemia (low blood sugar).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to insulin regular: injectable solution, subcutaneous solution

Ocular

Frequency not reported: Transitory, reversible ophthalmologic refraction disorder, worsening diabetic neuropathy[Ref]

Transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for diabetic neuropathy.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy[Ref]

Long-term use of insulin can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissues).[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site
Very rare (less than 0.01%): Anaphylactic reactions[Ref]

Hypersensitivity reactions have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks. In some instances these reactions have been caused by other factors such as irritants in a skin cleansing agent or poor injection technique. Localized reactions have been reported with metacresol, which is an excipient in many insulin products.

Generalized allergy to insulin may present as a whole body rash, dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.[Ref]

Immunologic

Increases in titers of anti-insulin antibodies that react with human insulin have been observed; some data indicates the increase is transient. The clinical significance of these antibodies is unknown; it does not appear to cause deterioration in glycemic control.[Ref]

Frequency not reported: Formation of anti-insulin antibodies[Ref]

Cardiovascular

Frequency not reported: Sodium retention and edema[Ref]

Insulin may cause sodium retention and edema, especially with intensified insulin therapy. Combination use with thiazolidinediones has resulted in fluid retention which has led to or exacerbated heart failure.[Ref]

General

Adverse reactions reported with this insulin include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, and edema[Ref]

Metabolic

Very common (10% or more): Hypoglycemia
Rare (less than 0.1%): Insulin resistance
Frequency not reported: Hypokalemia, hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic non-ketotic syndrome, hypomagnesemia, hypophosphatemia[Ref]

Hypoglycemia is the most common adverse reaction of all insulin therapies. The timing of hypoglycemia generally reflects the time-action profile of the administered insulin, however, the time action profile of any insulin may vary considerably in different individuals or at different times in the same individual depending on dose, site of injection, blood supply, temperature, and physical activity. Other factors such as changes in food intake (timing of meals, amount or type of food) and concomitant medications will also affect the risk of hypoglycemia.

Hypokalemia, which is due to a shift in potassium from the extracellular to the intracellular space, occurs with all insulins. Hypokalemia and hypomagnesemia has been reported, particularly in patients treated for diabetic ketoacidosis (DKA). Insulin increases the intracellular transport of phosphate, which often results in hypophosphatemia during treatment of DKA. In situations in which not enough insulin is available to control blood glucose, hyperglycemia, diabetic ketoacidosis, and hyperosmolar hyperglycemic non-ketotic syndrome may occur.[Ref]

Local

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching have occurred. These usually resolve in a few days to a few weeks; rotation of the injection site reduces the risk of these reactions developing.[Ref]

Common (1% to 10%): Injection site hypertrophy
Frequency not reported: Injection site reactions[Ref]

Nervous system

Frequency not reported: Acute painful peripheral neuropathy[Ref]

Acute painful peripheral neuropathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for neuropathy.[Ref]

Other

Weight gain can occur with insulin use; it is believed to be due to the anabolic effects of insulin and the decrease in glucosuria.[Ref]

Frequency not reported: Weight gain[Ref]

Some side effects of ReliOn / Humulin R may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.