Generic

Insulin Human [rDNA] + Isophane Insulin Human

Indications

Treat all patients with type 1 diabetes Treat patients with type 2 diabetes who are not adequately controlled by diet and/or oral hypoglycemic drugs is used for diabetic initial stabilization in patients with diabetic ketoacidosis and non-ketotic hyperosmolar syndrome, as well as during stressful periods such as severe infections and major operations in diabetic patients. Treatment of gestational diabetes.

Pharmacology

Human insulin (rDNA) is human insulin made using recombinant DNA technology. It has the same structure and function as natural insulin. Insulin regulates glucose metabolism and stimulates glucose uptake and utilization by the liver, muscles, and adipose tissue. It also lowers blood sugar by speeding up sugar production and inhibiting gluconeogenesis.

Insulin Human (rDNA) 30/70 and Insulin Human (rDNA) 50/50 start to work within 30 minutes after injection, peak in 28 hours, and last approximately 24 hours.

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.

Administration

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) 30/70 & Insulin Human (rDNA) 50/50 are 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.

Interaction

When using oral contraceptives, adrenal cortex hormones, thyroid hormones and other drugs that can increase blood sugar; it may be necessary to increase the amount of insulin. When using antidepressants such as salicylate, sulfa, etc., which have the effect of lowering blood sugar, it will cause the blood sugar to drop, so the insulin dose should be reduced.

Contraindications

Hypoglycemia is the most common adverse reaction during insulin treatment, and symptoms of hypoglycemia can appear suddenly. There are few reports of allergic reactions such as redness and itching. It usually disappears after a few days. In some cases, allergies may be due to reasons other than insulin, such as disinfectants and poor injection techniques.

Side Effects

There are no restrictions on the use of insulin to treat diabetes during pregnancy because insulin cannot cross the placental barrier. Insulin therapy for breastfeeding mothers does not pose any risk to the baby.

Pregnancy & Lactation

There are no restrictions on the use of insulin to treat diabetes during pregnancy because insulin cannot cross the placental barrier. Insulin therapy for breastfeeding mothers does not pose any risk to the baby.

Precautions & Warnings

Therapeutic Class

Medium Acting Insulin

Storage Conditions

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.

Pharmaceutical Name

ACI Limited