Indications

This combination is a mixture of Insulin Aspart and Insulin Aspart Protamine indicated to improve glycemic control in patients with diabetes mellitus.

Composition

• Insulin Aspart (rDNA) BP 100 IU (equivalent to 3.5 mg) as 30% Soluble Insulin Aspart
• 70% Insulin Aspart Protamine

Pharmacology

Insulin Aspart & Insulin Aspart Protamine is a human insulin analog suspension containing 30% Insulin Aspart & 70% Insulin Aspart Protamine used to lower blood glucose. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the Amino Acid Proline by Aspartic Acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). The primary activity of insulin, including Insulin Aspart is the regulation of glucose metabolism. Insulin, and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Dosage & Administration

This insulin is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). Individualize and adjust the dosage based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function or during acute illness. Dosage adjustment may be needed when switching from another insulin to this insulin. Or, as directed by the registered physician. Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Renal and Hepatic Impairment: Reduction the dose may require in these cases.

Contraindications

Insulin Aspart is contraindicated during episodes of hypoglycemia, in patients with hypersensitivity to this drug or one of its excipients.

Side Effects

Most common side effects are hypoglycemia, hypersensitivity and allergic reactions, hypokalemia, injection site reaction, lipodystrophy, pruritus and rash.

Pregnancy & Lactation

Pregnancy category B. There are no available data in pregnant women to inform a drug-associated risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. There are no data on the presence of Insulin in human milk, the effect on breastfed infants, or the effect on milk production.

Precautions & Warnings

Therapeutic Class

Rapid Acting Insulin

Storage Conditions

Storage when not in use: Store in a refrigerator (2°C to 8°C). Do not freeze. After removing from the refrigerator, it is recommended to allow to reach room temperature before resuspending the insulin for the first time use. Storage during use: This is being used is not kept in the refrigerator. It can be kept at room temperature (below 30°C) for up to 4 weeks. Keep the cartridge in the outer carton in order to protect from light. This must be protected from excessive heat and light.