Ansulin R 100 IU/ml

Description

Indications

Ansulin R Injection is indicated for:

• Treatment of all patients with Type 1 diabetes.
• Treatment of Type 2 diabetes patients 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 surgery in diabetic patients.
• Treatment of gestational diabetes.

Use as directed by a registered physician.

Composition

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

Pharmacology

Ansulin R is a sterile, clear, and colorless solution of Insulin Human. It is a fast-acting insulin with a relatively short duration of action compared to other insulins. It may be used in combination with long-acting insulins.

The blood glucose-lowering effect of insulin occurs through the facilitated uptake of glucose following its binding to receptors on muscle and fat cells, as well as inhibiting glucose production from the liver.

• Half-life: A few minutes in the bloodstream with no significant binding to plasma proteins.
• Action Profile:
  • Onset of action: Within 30 minutes.
  • Peak plasma levels: 1-3 hours.
  • Duration of action: Approximately 4-6 hours.

Dosage

Dosage should be individualized and determined by the physician based on the patient’s needs.

• Type 1 diabetes: The average daily insulin requirement is between 0.5 and 1.0 IU/kg, with pre-pubertal children requiring approximately 0.7 to 1.0 IU/kg.
• Type 2 diabetes: Initial dosages usually range from 0.3 to 0.6 IU/kg/day.
• Insulin Requirement Variations: Higher doses may be needed in cases of insulin resistance (e.g., during puberty or obesity) or lower in patients with endogenous insulin production.

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

Use as directed by a registered physician.

Administration

Ansulin R is typically administered subcutaneously in the abdominal wall, although other areas such as the thigh, gluteal region, or deltoid region can be used. Subcutaneous injections in the abdominal wall ensure faster absorption compared to other sites.

To avoid lipodystrophy, rotate injection sites within the same anatomical region. Intramuscular injections are possible under medical supervision, and intravenous injections should only be administered by a healthcare professional.

Dosage Adjustment

• Illnesses like infections and fever may increase insulin requirements.
• Renal or hepatic impairment may reduce insulin requirements.
• Physical activity or dietary changes may require dosage adjustments.
• Changes in insulin preparations may also necessitate a dosage adjustment.

Use as directed by a registered physician.

Interaction

Certain substances may affect insulin requirements:

• Decrease insulin requirements: Oral hypoglycemic agents, monoamine oxidase inhibitors, non-selective beta-blockers, ACE inhibitors, salicylates, and alcohol.
• Increase insulin requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, and danazol.

Beta-blockers may mask hypoglycemia symptoms and delay recovery. Octreotide/lanreotide may both increase and decrease insulin needs. Alcohol may intensify and prolong hypoglycemic effects.

Contraindications

Insulin should not be administered to patients with hypoglycemia or hypersensitivity to human insulin or any of its excipients.

Side Effects

• Hypoglycemia: Most common side effect, especially if the insulin dose is too high.
• Lipodystrophy: May occur due to failure to rotate injection sites.
• Hypersensitivity reactions: Symptoms may include skin rash, itching, gastrointestinal upset, angioedema, difficulty breathing, palpitation, and hypotension. These reactions are potentially life-threatening.
• Oedema: May occur at the beginning of insulin therapy but usually resolves over time.

Pregnancy & Lactation

Insulin treatment is safe during pregnancy, as it does not cross the placental barrier. Both hypoglycemia and hyperglycemia can increase the risk of malformations and fetal death. Insulin requirements generally decrease in the first trimester and increase during the second and third trimesters. After delivery, insulin needs return to pre-pregnancy levels. Insulin therapy in breastfeeding mothers is safe, though adjustments to dosage and diet may be necessary.

Precautions & Warnings

• Inadequate dosing or discontinuation, especially in Type 1 diabetes, can lead to hyperglycemia, which may result in diabetic ketoacidosis.
• Hypoglycemia can occur if the insulin dose exceeds the body’s requirement.
• Switching insulin types or brands should be done under strict medical supervision.
• Time zone changes may require adjustments to insulin and meal schedules.

Overdose Effects

Hypoglycemia can occur in stages due to overdose:

• Mild hypoglycemia: Can be treated with oral glucose or sugar.
• Severe hypoglycemia: Requires glucagon (0.5-1 mg) injected intramuscularly or subcutaneously by a trained individual, or intravenous glucose administered by a healthcare professional.

After regaining consciousness, oral carbohydrates should be given to prevent relapse.

Therapeutic Class

Medium-Acting Insulin

Storage Conditions

• Store Ansulin R between 2°C and 8°C in a refrigerator. Do not use if frozen.
• Protect from light and store in the outer carton.
• Once in use, the vial can be stored below 25°C for up to 6 weeks or below 30°C for up to 4 weeks.
• Do not refrigerate the vial once in use.