Ansulin N 100 IU/ml

Description

Indications:

Ansulin N Injection is indicated for:

• 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
• Initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome, and during periods of stress such as severe infections and major surgeries in diabetic patients
• Treatment of gestational diabetes

Use as per the advice of a registered medical practitioner.

Composition:

• Insulin Human R (40 IU/ml): Each ml of solution contains 40 IU (equivalent to 1.388 mg) of Insulin Human (rDNA) USP as Soluble Insulin Human (Regular).
• Insulin Human R (100 IU/ml): Each ml of solution contains 100 IU (equivalent to 3.47 mg) of Insulin Human (rDNA) USP as Soluble Insulin Human (Regular).
• Insulin Human N (40 IU/ml): Each ml of suspension contains 40 IU (equivalent to 1.388 mg) of Insulin Human (rDNA) USP as Isophane Insulin Human.
• Insulin Human N (100 IU/ml): Each ml of suspension contains 100 IU (equivalent to 3.47 mg) of Insulin Human (rDNA) USP as Isophane Insulin Human.

Pharmacology:

Ansulin N is a sterile, clear, colorless solution of Insulin Human. It is a fast-acting insulin with a relatively short duration of action compared to other insulins. The blood glucose-lowering effect occurs due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells, along with the inhibition of glucose output from the liver.

Insulin has a half-life of only a few minutes in the bloodstream and does not have significant binding to plasma proteins. The typical action profile after subcutaneous injection includes:

• Onset of action: Within 30 minutes
• Peak plasma levels: Between 1-3 hours
• Duration of action: Approximately 4-6 hours

Dosage:

Dosage is individualized and determined by the prescribing physician according to the patient’s needs.

• For type 1 diabetes, the average range of total daily insulin requirements is between 0.5 and 1.0 IU/Kg. In pre-pubertal children, it generally 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 or due to obesity) and lower in patients with endogenous insulin production or during partial remission.
• For type 2 diabetes, initial dosages are typically between 0.3 to 0.6 IU/Kg/Day.

An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.

Use as per the advice of a registered medical practitioner.

Administration:

Ansulin N is typically administered subcutaneously into the abdominal wall, although the thigh, gluteal region, or deltoid region may also be used. Subcutaneous injection into the abdominal wall ensures faster absorption compared to other sites. Injection sites should be rotated within the same anatomical region to avoid lipodystrophy.

Intramuscular administration is possible under a physician’s guidance, while intravenous administration should only be performed by a healthcare professional.

Dosage Adjustment:

• Concomitant illness, especially infections and fever, usually increases the insulin requirement.
• Renal or hepatic impairment may decrease insulin requirements.
• Dosage adjustments may be necessary if the patient changes physical activity or diet.
• If transferring patients to another insulin preparation, dosage adjustment may be required.

Use as per the advice of a registered medical practitioner.

Interaction:

Certain substances may influence insulin requirements:

• Substances that may reduce insulin requirements: Oral hypoglycemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, and alcohol.
• Substances that may increase insulin requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, and danazol.

Beta-blockers may mask symptoms of hypoglycemia and delay recovery. Octreotide/lanreotide may both increase and decrease insulin requirements. Alcohol may intensify and prolong the hypoglycemic effect.

Contraindications:

Ansulin N should never be administered to patients with:

• Hypoglycemia
• Hypersensitivity to human insulin or any of the excipients

Side Effects:

Adverse reactions with human insulin are primarily dose-dependent and related to its pharmacologic effects. The most common undesirable effect is hypoglycemia, which can occur if the insulin dose is too high relative to the patient’s insulin requirements.

Other side effects include:

• Lipodystrophy: Can occur at the injection site if injection sites are not rotated.
• Generalized hypersensitivity: Symptoms may include skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, breathing difficulties, palpitation, and a drop in blood pressure. These reactions are potentially life-threatening.
• Edema: May occur during the initiation of insulin therapy and is usually transient.

Pregnancy & Lactation:

• Pregnancy: There are no restrictions on the use of insulin during pregnancy as it does not pass the placental barrier. However, uncontrolled diabetes (hypoglycemia or hyperglycemia) can increase the risk of malformations and fetal death.
• Lactation: Insulin therapy during lactation poses no risk to the infant, although insulin dosage may need adjustment.

Precautions & Warnings:

• Inadequate dosing or discontinuation of insulin therapy, particularly in type 1 diabetes, may lead to hyperglycemia, which can progress to diabetic ketoacidosis (potentially fatal).
• Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement.
• Patients transferring to a new type or brand of insulin should do so under strict medical supervision.
• Changes in insulin dosage may be required due to variations in insulin strength, brand, or manufacturing process.
• Before traveling to different time zones, consult a doctor, as this may necessitate changes in insulin timing.

Overdose Effects:

• Insulin overdose does not have specific definitions but can lead to hypoglycemia in stages.
• Mild hypoglycemia can be treated with oral glucose or sugary products.
• Severe hypoglycemia (unconsciousness) can be treated with glucagon (0.5 to 1 mg) or intravenous glucose by a trained professional. If the patient does not respond to glucagon within 10 to 15 minutes, intravenous glucose should be administered.

Upon regaining consciousness, oral carbohydrate intake is recommended to prevent relapse.

Therapeutic Class:

Medium Acting Insulin

Storage Conditions:

• Store Ansulin N between 2°C and 8°C (in a refrigerator).
• Do not use if the preparation has been frozen.
• Keep in the outer carton to protect from light.
• Protect from excessive heat and sunlight.
• The solution should be clear and colorless. Do not use if it appears cloudy or contains particles.
• Once in use, the vial may be used for up to 6 weeks when stored below 25°C or for 4 weeks when stored below 30°C.