Insulatard Novolet

Uses

Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents.

For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.

Insulatard Novolet is also used to associated treatment for these conditions: Diabetes Mellitus, Type 1 Diabetes Mellitus

How Insulatard Novolet works

The primary activity of insulin is the regulation of glucose metabolism. Insulin promotes glucose and amino acid uptake into muscle and adipose tissues, and other tissues except brain and liver. It also has an anabolic role in stimulating glycogen, fatty acid, and protein synthesis. Insulin inhibits gluconeogenesis in the liver. Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism and catabolism.

Dosage

Insulatard Novolet dosage

The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, whereas in insulin resistant cases, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.

The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction.

An injection should be followed by a meal or snack containing carbohydrates within 30 minutes. Injection is administered subcutaneously in the upper arm, thigh, buttock or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites. Insulin Human (rDNA) R can be given intravenously only by the physician in emergency situations. However, Insulin Human (rDNA) N, is never to be administered intravenously.Preparation before use:

• Clean your hands.
• Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
• In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab.
• Draw air into your syringe equal to the amount of insulin needed.
• Puncture the needle into the vial and inject the air.
• Turn the bottle and syringe upside down and withdraw correct dose of insulin into the syringe.
• Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles.

Injection site:

• Choose the area where skin is less tight, such as the upper arm, thigh, buttock or abdomen.
• To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.

Injection method:

• Cleanse the skin with alcohol where the injection is to be made.
• Put the needle in such a position as to form 45° angle with the skin.
• Puncture the needle into skin and inject insulin.
• Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected.
• Pull the needle out and apply gentle pressure over the injected site for several seconds.
• Do not rub the injection site.

Side Effects

Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.

Precaution

Inadequate dosing or discontinuation especially in type 1 diabetes, may lead to hyperglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia.

Interaction

When using oral contraceptive drug, adrenal cortical hormone, thyroid hormone, etc., the drugs that can result in the rise of blood glucose; you might need to increase the amount of Insulin. When using drugs with hypoglycemic activities, salicylate, sulfanilamide and other anti-depressants, which will result in the decrease of blood glucose, the dosage of insulin should be reduced.

Food Interaction

• Avoid alcohol. Alcohol may impair blood glucose control.

Elimination Route

When injected subcutaneously, the glucose-lowering effect of human insulin begins approximately 30 minutes post-dose. After a single subcutaneous administration of 0.1 unit/kg of human insulin to healthy subjects, peak insulin concentrations occurred between 1.5 to 2.5 hours post-dose.

When administered in an inhaled form (as the product Afrezza), the time to maximum serum insulin concentration ranges from 10-20 minutes after oral inhalation of 4 to 48 units of human insulin. Serum insulin concentrations declined to baseline by approximately 60-240 minutes for these dose levels. Intrapatient variability in insulin exposure measured by AUC and Cmax is approximately 16% (95% CI 12-23%) and 21% (95% CI 16-30%), respectively.

Half Life

Systemic insulin disposition (apparent terminal half-life) following oral inhalation of 4 to 48 units of human insulin was 120-206 minutes.

Elimination Route

Following oral inhalation of human insulin, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces.

Pregnancy & Breastfeeding use

There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Insulin treatment of the nursing mother presents no risk to the baby.

Contraindication

Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.

Acute Overdose

Excessive use of insulin may lead to hypoglycemia during the treatment. Slight to moderate hypoglycemia may suddenly occur. It is important to get immediate treatment when hypoglycemia occurs. If you have frequent hypoglycemia, you should consult your doctor to discuss possible changes in therapy, diet plans, and/or exercise programs to help you avoid hypoglycemia.

Storage Condition

Store at 2°C - 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.

Innovators Monograph

You find simplified version here Insulatard Novolet