Generic

Insulin Human [Long-Acting]

Indications

Treat all patients with type 1 diabetes. Treat patients with type 2 diabetes who cannot be adequately controlled with diet and / or oral hypoglycemic agents. For patients with diabetic ketoacidosis, nonketotic hyperosmolar syndrome, and diabetic patients with severe infections and operations important for the initial stability of diabetes during stressful periods. Treatment of gestational diabetes.

Pharmacology

The hypoglycemic effect of insulin is due to the fact that insulin binds to muscle and fat cell receptors to promote glucose absorption and at the same time inhibit glucose produced by the liver. Insulatard is a long-acting insulin. It takes 1 and a half hours to take effect, and the maximum effect is reached in 412 hours. The total duration is about 24 hours.

The half-life of insulin in the blood is only a few minutes. Therefore, the time-effect curve of insulin preparations is only determined by their absorption characteristics. This process is affected by many factors (such as insulin dose, injection route and location, thickness of subcutaneous fat, type of diabetes). Therefore, the pharmacokinetics of insulin is affected by significant intra- and inter-individual differences.

Dosage

Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.

The physician determines one or several daily injections are necessary. Insulatard may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is recommended.

Administration

For subcutaneous use. Insulatard is usually administered subcutaneously in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.

Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin

Interaction

Several drugs are known to interact with glucose metabolism. Therefore, doctors must be aware of potential interactions and should always ask patients about any medications they take. The following substances may reduce insulin requirements: oral hypoglycemic agents (OHA), monoamine oxidase inhibitors (MAOIs), non-selective beta blockers, angiotensin converting enzyme (ACE) inhibitors, salicylate, and Alcohol.

The following substances may increase insulin requirements: thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetic drugs, growth hormones, and danazol. Beta blockers can mask the symptoms of hypoglycemia and delay the recovery of hypoglycemia. Octreotide / lanreotide can reduce and increase insulin needs. Alcohol can strengthen and prolong the hypoglycemic effect of insulin.

Contraindications

Hypoglycaemia, Hypersensitivity to human insulin or to any of the excipients

Side Effects

Hypoglycemia is the most common side effect during insulin treatment, and symptoms of hypoglycemia will appear suddenly. Few cases of allergic reactions have been reported, such as redness or itching. It usually disappears within a few days. In some cases, allergies may be caused by reasons other than insulin, such as disinfectants and poor injection techniques.

Pregnancy & Lactation

There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.

Precautions & Warnings

Therapeutic Class

Long Acting Insulin

Storage Conditions

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the container cartridge or vial in the outer carton in order to protect from light.

During use: do not refrigerate. Do not store vials above 25°C and cartridges above 30°C. Protect from excessive heat and sunlight.

Pharmaceutical Name

ACI Limited