Insul N

Indication

• 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

Dosage & Administration

Dosage is individual and determined by the physician in accordance with the needs of the patient. 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. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty in the young or due to obesity) and lower in patients with endogenous insulin production or during the period of partial remission. Initial dosage for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/ Kg/ Day. The physician determines whether one or several daily injections are necessary. Isophane suspension 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.
Administration
It 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. In order to avoid lipodystrophy, injection sites for a given insulin preparation should be rotated within an anatomic region. Insulin suspensions are never to be administered intravenously. The bottle must be carefully shaken or rotated before each injection so that the contents are uniformly mixed. They should look uniformly cloudy or milky after mixing.
Dosage Adjustment
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement. Renal or hepatic impairment may reduce insulin requirement. Adjustment of the dosage may also be necessary if patients change physical activity or their usual diet. Dosage adjustment may be necessary when transferring patients from one insulin preparation to another.

Precautions

Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia. In type 1diabetes, untreated hyperglycemic events eventually leads to diabetic ketoacidosis which is potentially lethal. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (rapid acting insulin, dual acting insulin, intermediate and long acting insulin etc.), species (animal, human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.

Before travelling between different time zones, the patients should be advised to consult the doctor, since this may mean that the patients has to take insulin and meals at different time. It should not be used if there are clumps in the insulin after mixing and should not be used if solid white particles stick to the bottom or wall of the bottle, giving it a frosted appearance.

To Mix Isophane Suspension with Fast-Acting Insulin
1. Roll the vial of Isophane suspension between the hands. Do this until the liquid is uniformly white and cloudy
2. Draw as much air into the syringe as the dose of suspension needed. Inject the air into the suspension vial, then pull out the needle
3. Draw as much air into the syringe as the dose of fast-acting insulin needed. Inject the air into the fast-acting insulin vial. Then turn the vial and syringe upside down.
4. Draw the right dose of fast-acting insulin into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check the dose.
5. Now push the needle into the vial of suspension. Then turn the vial and syringe upside down.
6. Draw the right dose of suspension into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe, and check the dose.
7. Inject the mixture straight away.
Pregnancy and Lactation
There are no restrictions on the treatment of diabetes with insulin during pregnancy as insulin does not pass the placental barrier. Both hypoglycemia and hyperglycemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy values. Insulin treatment of the nursing mother involves no risk to the baby. However, the insulin dosage, diet or both may need to be adjusted.