Insulin Aspart + Insulin Aspart Protamine

Insulin Aspart + Insulin Aspart Protamine is a human insulin analog suspension containing 30% soluble Insulin Aspart and 70% Insulin Aspart Protamine used to lower blood glucose. Insulin Aspart is homologous with regular human insulin except for a single substitution of proline by aspartic acid at position B28. It stimulates peripheral glucose uptake, inhibits hepatic glucose production, inhibits lipolysis and proteolysis, and enhances protein synthesis.

• Improvement of glycemic control in patients with diabetes mellitus

Adult Dose (Subcutaneous):

• Typically dosed twice daily (each dose intended to cover 2 meals or a meal and a snack)
• Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal
• Dosage adjustments may be needed with changes in physical activity, meal patterns, renal or hepatic function

Renal and Hepatic Impairment: Dose reduction may be required

Side Effects:

• Hypoglycemia
• Hypersensitivity and allergic reactions
• Hypokalemia
• Injection site reactions
• Lipodystrophy
• Pruritus
• Rash

Precautions:

• Renal and hepatic impairment may require dose reduction
• Do not use if resuspended insulin does not look uniformly white and cloudy
• At least 12 units of insulin must remain in cartridge (for even resuspension)
• Use a new needle for each injection (to prevent contamination)
• Always check insulin labels before administration

Contraindications:

• Hypoglycemia
• Hypersensitivity to Insulin Aspart or any of its excipients

Drug Interactions:

• Anti-diabetic agents, ACE inhibitors, angiotensin II receptor blockers, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analog, sulfonamide antibiotics decrease insulin requirements
• Atypical antipsychotics, corticosteroids, danazol, diuretics, estrogen, glucagon, isoniazid, niacin, oral contraceptives, phenothiazine, progestogens, protease inhibitors, somatropin, sympathomimetic agents, thyroid hormones increase insulin requirements
• Beta-blockers, clonidine, lithium salts, alcohol, pentamidine may either potentiate or weaken insulin effect
• Beta-blockers, clonidine, guanethidine, reserpine may blunt signs/symptoms of hypoglycemia

Use in Pregnancy: Category B; no data available in pregnant women; risks to mother and fetus associated with poorly controlled diabetes in pregnancy.

Use in Lactation: No data on presence of insulin in human milk, effects on breastfed infants, or effects on milk production.

Renal Impairment: Dose reduction may be required.

Hepatic Impairment: Dose reduction may be required.

Overdose: Excess insulin administration may cause hypoglycemia and, particularly when given intravenously, hypokalemia; mild episodes treated with oral glucose; adjustments in drug dosage, meal patterns, or exercise may be needed; hypokalemia must be corrected appropriately.