Ansulin R 100 IU/ml

Description

Indications
Ansulin R Injection is recommended for the following conditions:

• Treatment of type 1 diabetes in all patients.
• Treatment of type 2 diabetes in patients who are not adequately controlled by diet and/or oral hypoglycemic medications.
• Initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome, or during periods of significant stress, such as severe infections or major surgeries in diabetic patients.
• Management of gestational diabetes.

Please follow the guidance of a registered healthcare provider while using this medication.

Composition
Each formulation of Ansulin R contains the following active ingredients:

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

Pharmacology
Ansulin R is a sterile, clear, colorless solution containing Insulin Human, which acts rapidly with a relatively short duration of action compared to other insulin types. It may be used in combination with long-acting insulins for optimal glucose control.
Insulin lowers blood glucose levels by promoting glucose uptake into muscle and fat cells while inhibiting glucose production in the liver.

Pharmacokinetic details after subcutaneous injection:

• Onset of action: Within 30 minutes
• Peak plasma concentration: 1-3 hours
• Duration of action: Approximately 4-6 hours
• Half-life: Brief, with minimal binding to plasma proteins.

Dosage
The insulin dosage should be individualized based on the patient’s needs and determined by a healthcare provider.

• Type 1 diabetes: The typical daily insulin requirement is between 0.5 and 1.0 IU/kg. For pre-pubertal children, this generally ranges from 0.7 to 1.0 IU/kg.
• Type 2 diabetes: Initial doses are often lower, typically ranging from 0.3 to 0.6 IU/kg/day.
• Special considerations: Insulin needs may be higher in patients with insulin resistance (e.g., during puberty or in obese individuals) or lower in those with partial insulin production.

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

Please consult with a registered healthcare provider before using this medication.

Administration
Ansulin R is generally administered subcutaneously, with the most common injection site being the abdominal wall. The thigh, gluteal region, or deltoid area can also be used.

• Subcutaneous injection in the abdominal area ensures faster absorption compared to other sites.
• To avoid lipodystrophy, it is important to rotate injection sites within the same region.
• Intramuscular injections are possible under medical supervision.
• Intravenous administration should only be performed by a healthcare professional.

Dosage Adjustment
Insulin requirements may increase due to infections or fever, and may decrease in cases of renal or hepatic impairment. Additionally, changes in physical activity or diet may require dosage adjustments.
When switching between different insulin formulations, dosage adjustments may be necessary.

Interactions
Certain medications may affect insulin requirements. These include:

• Decreased insulin requirement: Oral hypoglycemic agents (OHA), monoamine oxidase inhibitors (MAOIs), non-selective beta-blockers, ACE inhibitors, salicylates, and alcohol.
• Increased insulin requirement: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, and danazol.

It is important to note that beta-blockers may mask symptoms of hypoglycemia and delay recovery. Alcohol may intensify the hypoglycemic effect of insulin.

Contraindications
Ansulin R should not be used in patients who:

• Are experiencing hypoglycemia.
• Have a hypersensitivity to human insulin or any of the excipients in the product.

Side Effects
Common adverse effects associated with human insulin are generally dose-dependent. The most common undesirable effect is hypoglycemia, which can occur if the insulin dose is too high relative to the patient’s needs.

• Lipodystrophy: Can develop at injection sites if rotation of injection sites is not practiced.
• Hypersensitivity reactions: Symptoms may include generalized skin rash, itching, gastrointestinal upset, angioneurotic edema, breathing difficulties, palpitations, and reduced blood pressure. Severe reactions can be life-threatening.
• Edema: May occur upon initiation of insulin therapy but is typically temporary.

Pregnancy and Lactation
Insulin therapy during pregnancy does not pose a risk to the fetus, as insulin does not cross the placental barrier. However, poorly controlled diabetes, resulting in either hypoglycemia or hyperglycemia, increases the risk of malformations and fetal death. Insulin requirements generally decrease during the first trimester and increase during the second and third trimesters. Post-delivery, insulin requirements quickly return to pre-pregnancy levels. Insulin treatment for nursing mothers does not pose a risk to the infant, although insulin dosage may need adjustment.

Precautions & Warnings

• Hyperglycemia: Inadequate insulin dosing, especially in type 1 diabetes, can lead to hyperglycemia and eventually diabetic ketoacidosis, which is a life-threatening condition.
• Hypoglycemia: If the insulin dose is too high, hypoglycemia may occur.
• When switching between insulin preparations, patients should do so under strict medical supervision, as changes in dosage may be necessary.
• Time zone changes: Patients traveling across time zones should consult with their healthcare provider for guidance on adjusting insulin and meal times.

Overdose Effects
Ansulin R does not have a defined overdose threshold, but excess insulin may cause hypoglycemia.

• Mild hypoglycemia can be treated with oral glucose or sugary foods.
• Severe hypoglycemia, where the patient loses consciousness, can be treated with glucagon (0.5-1 mg) injected intramuscularly or subcutaneously by a trained person or by intravenous glucose administered by a healthcare professional.
• After regaining consciousness, oral carbohydrate should be administered to prevent relapse.

Therapeutic Class
Medium-Acting Insulin

Storage Conditions
Ansulin R should be stored between 2°C and 8°C (in a refrigerator). It should not be used if it has been frozen. The vial should be kept in its outer carton to protect it from light and should be stored away from excessive heat or sunlight. Once in use, the vial should be kept at temperatures below 25°C and can be used for up to 6 weeks. If stored at temperatures above 30°C, it should be used within 4 weeks.