Ansulin 30%+70% in 100 IU/ml

Description

Indications
Ansulin injection is indicated for the treatment of:

• All patients with Type 1 diabetes
• Patients with Type 2 diabetes who are not adequately controlled by diet and/or oral hypoglycemic agents
• 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
• Treatment of gestational diabetes

Take this medicine only as prescribed by a registered healthcare professional.

Composition

• 30/70: Each ml of the suspension contains 100 IU (equivalent to 3.47 mg) of Insulin Human (rDNA) USP, with 30% Regular Insulin Human and 70% Isophane Insulin Human.
• 50/50: Each ml of the suspension contains 100 IU (equivalent to 3.47 mg) of Insulin Human (rDNA) USP, with 50% Regular Insulin Human and 50% Isophane Insulin Human.

Pharmacology
The blood glucose-lowering effect of insulin occurs through the facilitated uptake of glucose after insulin binds to receptors on muscle and fat cells, while simultaneously inhibiting glucose production by the liver. Insulin has a short half-life in the bloodstream and does not bind profoundly to plasma proteins.

The average action profile after subcutaneous injection includes:

• Onset of action: within 30 minutes
• Peak plasma levels: between 1-3 hours
• Duration of action: approximately 18-24 hours

Dosage
The dosage of Ansulin is individualized and determined by the physician according to the patient’s needs.

• For Type 1 diabetic patients, the average total daily insulin requirement for maintenance therapy is between 0.5 and 1.0 IU/kg. In pre-pubertal children, this typically ranges from 0.7 to 1.0 IU/kg.
• The daily insulin requirement may be higher in patients with insulin resistance (e.g., puberty or obesity) and lower in patients with some level of endogenous insulin production or during partial remission.
• For Type 2 diabetic patients, the initial dosage is often lower, typically between 0.3 and 0.6 IU/kg/day.

Insulin should be administered within 30 minutes of a meal or snack containing carbohydrates.

Take this medicine only as prescribed by a registered healthcare professional.

Administration
Ansulin is generally administered subcutaneously, with the abdominal wall being the preferred site for faster absorption. The thigh, gluteal, or deltoid regions may also be used. To prevent lipodystrophy, injection sites within a given anatomical area should be rotated regularly.

Dosage Adjustment

• Illnesses, particularly infections and fever, may increase insulin requirements.
• Renal or hepatic impairment may reduce insulin requirements.
• Changes in physical activity or diet may necessitate dosage adjustments.
• Dosage adjustments may be required when transitioning from one insulin preparation to another.

Before Using Insulin 30/70

• Ensure that it is the correct type of insulin.
• Check the cartridge and ensure it is not damaged.
• Disinfect the rubber membrane with surgical spirit.
• Do not use insulin if the cartridge or device has been dropped or crushed, or if it has been improperly stored or frozen.
• Insulin should be uniformly white and cloudy when mixed.

Mixing the Insulin

• Before placing the cartridge into the insulin delivery system, gently move it up and down between positions A and B to mix it. Repeat this 20 times before the first use and at least 10 times before every subsequent injection.
• If the cartridge is already inside the delivery system, move it up and down at least 10 times before each injection.

How to Inject

• Inject insulin subcutaneously using the injection technique described in the delivery system manual.
• Keep the needle under the skin for at least 6 seconds to ensure full dose delivery.
• After injection, remove the needle immediately to avoid leakage and ensure consistent insulin strength.

Take this medicine only as prescribed by a registered healthcare professional.

Interaction
Other medications may influence insulin requirements. The following substances can reduce insulin requirements:

• Oral hypoglycemic agents (OHA)
• Monoamine oxidase inhibitors (MAOI)
• Non-selective beta-blockers
• Angiotensin-converting enzyme (ACE) inhibitors
• Salicylates and alcohol

Conversely, the following may increase insulin requirements:

• Thiazides
• Glucocorticoids
• Thyroid hormones
• Beta-sympathomimetics
• Growth hormone
• Danazol

Beta-blockers can mask hypoglycemia symptoms and delay recovery. Octreotide/Lanreotide may alter insulin requirements. Alcohol can intensify and prolong the hypoglycemic effect of insulin.

Contraindications
Do not use Ansulin if you:

• Are hypoglycemic
• Are hypersensitive to human insulin or any excipients

Side Effects
Common adverse reactions are dose-dependent and include:

• Hypoglycemia (most frequent side effect)
• Lipodystrophy (injection site reactions)
• Generalized hypersensitivity, including rash, itching, sweating, gastrointestinal upset, angioedema, breathing difficulties, palpitations, and low blood pressure. These reactions can be life-threatening.
• Edema, which is usually temporary at the initiation of insulin therapy.

Pregnancy & Lactation
Insulin use during pregnancy is not restricted, as it does not cross the placental barrier. Uncontrolled hypoglycemia or hyperglycemia can increase the risk of malformations and fetal death. Insulin needs may decrease during the first trimester and increase later in pregnancy, returning to pre-pregnancy levels after delivery. Insulin use during breastfeeding poses no risk to the baby, although dosage adjustments may be necessary.

Precautions & Warnings

• Inadequate dosing or discontinuation, especially in Type 1 diabetes, can lead to hyperglycemia, which may result in diabetic ketoacidosis, a potentially fatal condition.
• Hypoglycemia can occur if insulin dosage exceeds the requirement.
• Transitioning to another insulin type or brand should be done under medical supervision.
• Consult a doctor before traveling across time zones, as this may require insulin and meal adjustments.
• Do not use insulin if it is cloudy or has clumps, or if solid white particles adhere to the bottle, giving it a frosted appearance.

Overdose Effects
While no specific overdose guidelines exist for insulin, hypoglycemia may occur. Severe hypoglycemia can result in unconsciousness, requiring emergency treatment with glucagon (0.5-1 mg) or intravenous glucose. Once conscious, oral carbohydrates should be administered to prevent relapse.

Storage Conditions
Store insulin between 2°C and 8°C (in a refrigerator). Do not use insulin if it has been frozen. Keep it in its outer carton to protect from light. In use, the cartridge should be kept below 25°C for up to 6 weeks or below 30°C for up to 4 weeks. Always mix the insulin thoroughly before use.