Maxsulin R 100IU SC Injection 10ml

✔️ Composition of Maxsulin R Injection

Maxsulin R Injection contains human insulin produced through recombinant DNA technology (rDNA). The formulation is available in various strengths:

Insulin Human R (Regular Insulin) Solution:

• 40 IU/ml: Contains 40 IU (equivalent to 1.388 mg) of soluble human insulin per milliliter.
• 100 IU/ml: Contains 100 IU (equivalent to 3.47 mg) of soluble human insulin per milliliter.

Insulin Human N (Isophane Insulin) Suspension:

• 40 IU/ml: Contains 40 IU (1.388 mg) of isophane insulin per milliliter.
• 100 IU/ml: Contains 100 IU (3.47 mg) of isophane insulin per milliliter.

✔️ Side Effects

Side effects are typically dose-dependent and related to insulin’s pharmacological action:

• Hypoglycemia (low blood sugar): The most common adverse effect, especially when insulin doses exceed needs.
• Lipodystrophy: Changes in fat tissue at injection sites due to poor site rotation.
• Hypersensitivity Reactions: Symptoms may include rash, itching, sweating, gastrointestinal disturbances, angioedema, breathing difficulties, palpitations, and low blood pressure. Severe reactions can be life-threatening.
• Edema: May occur when insulin therapy is initiated but usually subsides.

✔️ Pharmacology

Maxsulin R is a sterile, clear, and colorless insulin solution. It is a fast-acting insulin with a relatively short duration of action compared to other insulin types. It can be used alone or in combination with long-acting insulins for better glucose control.

Mechanism of Action: Insulin lowers blood glucose by facilitating the uptake of glucose into muscle and fat cells while simultaneously inhibiting glucose production in the liver.

Pharmacokinetics:

• Half-life: Insulin has a short half-life of a few minutes in the bloodstream.
• Onset of Action: Approximately 30 minutes after subcutaneous injection.
• Peak Effect: Blood glucose levels reach their lowest point between 1 to 3 hours after injection.
• Duration of Action: Effects last for about 4 to 6 hours.

✔️ Dosage Guidelines of Maxsulin R 100IU SC Injection

Individualized Dosage:
The insulin dose is tailored to the individual by a physician based on the patient’s specific needs.

Type 1 Diabetes Maintenance Therapy:
The typical daily insulin requirement ranges between 0.5 to 1.0 IU per kg of body weight. For pre-pubertal children, the dose is usually between 0.7 to 1.0 IU per kg.

Type 2 Diabetes Initial Dosage:
Patients often start with lower doses, typically between 0.3 to 0.6 IU per kg per day.

Insulin Resistance:
Higher insulin doses may be needed during puberty or in cases of obesity. Conversely, doses may be lower if the body produces some insulin or during partial remission phases.

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

✔️ Overdose Management

No specific overdose definition exists, but hypoglycemia typically follows this progression:

Mild Hypoglycemia: Treated with oral glucose or sugary foods.

Severe Hypoglycemia (Unconsciousness):

• Administer glucagon (0.5 to 1 mg IM or SC) by a trained person.
• If no response, give intravenous glucose by a medical professional.
• After regaining consciousness, consume carbohydrates to prevent relapse.

✔️ Administration Instructions

Route of Administration:
Maxsulin R is typically administered subcutaneously, with the abdominal wall being the preferred site due to faster absorption. Alternative injection sites include the thigh, gluteal region, or deltoid muscle.

Injection Site Rotation:
To prevent lipodystrophy (fat tissue changes at injection sites), rotate injection sites within the same anatomical area regularly.

Intramuscular Injection:
May be administered intramuscularly under physician supervision.

Intravenous Injection:
Must only be carried out by a healthcare professional.

✔️ Dosage Adjustment Considerations

Illness & Infections:
Insulin requirements may increase during infections or febrile conditions.

Renal or Liver Impairment:
Patients with kidney or liver issues may need lower insulin doses.

Lifestyle Changes:
Adjustments are necessary if there are significant changes in physical activity or dietary habits.

Switching Insulin Types:
Dosage adjustments may be required when changing from one insulin preparation to another.

✔️ Drug Interactions

Certain medications can affect insulin requirements:

Medications that may decrease insulin needs:

• Oral hypoglycemic agents (OHA)
• Monoamine oxidase inhibitors (MAOI)
• Non-selective beta-blockers
• ACE inhibitors
• Salicylates
• Alcohol

Medications that may increase insulin needs:

• Thiazide diuretics
• Glucocorticoids
• Thyroid hormones
• Beta-sympathomimetics
• Growth hormone
• Danazol

Additional Considerations:

• Beta-blockers can mask hypoglycemia symptoms and delay recovery.
• Octreotide/Lanreotide may either increase or decrease insulin needs.
• Alcohol can intensify and prolong hypoglycemia.

✔️ Maxsulin R must not be used in patients who:

• Have hypoglycemia.
• Are hypersensitive to human insulin or any of the excipients?

✔️ Pregnancy and Lactation

• Pregnancy: Insulin is safe during pregnancy as it does not cross the placenta. Poor glucose control increases the risk of fetal malformations and intrauterine death. Insulin needs to decrease during the first trimester and increase in the second and third trimesters.
• Lactation: Insulin does not pose a risk to breastfeeding infants. Dosage adjustments may be needed for the mother.

✔️ Precautions and Warnings

• Inadequate dosing or stopping insulin, particularly in type 1 diabetes, may result in hyperglycemia and diabetic ketoacidosis, a potentially fatal condition.
• Hypoglycemia may occur if the dose is too high.
• Changing insulin type, brand, or manufacturing method requires careful dosage adjustments under medical supervision.
• Patients should consult their doctor before traveling across time zones due to possible adjustments in insulin and meal schedules.

✔️ Storage Conditions

• Store between 2°C to 8°C (refrigerated).
• Do not freeze. Frozen insulin is ineffective.
• Protect from light by keeping the vial in its outer carton.
• In-use vial: Store below 25°C (6 weeks) or 30°C (4 weeks).