Acilog Mix 30%+70%

INDICATIONS

Biphasic Insulin Aspart (rDNA) injection is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

PHARMACOLOGY

30% Insulin Aspart and 70% Insulin Aspart Protamine (rDNA) is a human insulin analog suspension containing 30 % soluble Insulin Aspart and 70% Insulin Aspart Protamine crystals. This is a blood glucose lowering agent with an earlier onset and an intermediate duration of action. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast).Primary function of insulin, including Insulin Aspart, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

DOSAGE

The dosage of insulin aspart must be individualized.Subcutaneous injection: insulin aspart should generally be given immediately (within 5-10 minutes) prior to the start of a meal.Use in pumps: Change the insulin aspart in the reservoir at least every 6 days, change the infusion set, and the infusion set insertion site at least every 3 days. insulin aspart should not be mixed with other insulins or with a diluent when it is used in the pump.Intravenous use: insulin aspart should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. insulin aspart has been shown to be stable in infusion fluids such as 0.9% sodiumchloride.

INTERACTION

A number of substances affect glucose metabolism and may require dose adjustment and particularly close monitoring.The following are examples that may increase the blood glucose lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide and angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, salicylates and sulfonamide antibiotics.The following substances are examples that may reduce the blood glucose lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, estrogens, progestogens, atypical antipsychotics and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

SIDE EFFECTS

Side effects of Insulin Aspart are hypoglycemia, lipodystrophy, weight gain, peripheral edema.

PREGNANCY & LACTATION

Pregnancy category B. Careful monitoring of glucose control is essential in such patients because insulin requirements change during different stages of pregnancy. Therefore female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking insulin aspartLactation: It is unknown whether Insulin Aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of insulin aspart in lactating women. Lactating Women may require adjustments of their insulin doses.

PRECAUTIONS & WARNINGS

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Renal or hepatic impairment: Reduction in the Insulin Aspart dose may require in these cases.

USE IN SPECIAL POPULATIONS

Pediatric: Has not been studied in children with type 2 diabetes. Has not been studied in children with type 1 diabetes <2 years of age

THERAPEUTIC CLASS

Combination Insulin

STORAGE CONDITIONS

Store at 2°C to 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.