Ansulin R

Approved Indications:

• Type 1 Diabetes Mellitus: For glycemic control in adults and children requiring exogenous insulin.
• Type 2 Diabetes Mellitus: For adults when oral antidiabetic agents are insufficient.
• Diabetic Ketoacidosis (DKA): As part of intensive insulin therapy in hospital settings.
• Hyperosmolar Hyperglycemic State (HHS): For acute management in hospitalized patients.

Clinically Accepted Off-Label Uses:

• Gestational Diabetes Mellitus (GDM): When lifestyle modification fails to achieve glycemic control.
• Parenteral Nutrition Support: To prevent hyperglycemia associated with total parenteral nutrition.
• Hyperkalemia Management: Used in combination with glucose to promote intracellular potassium shift.

• Routes: Subcutaneous (SC), Intravenous (IV), Intramuscular (rare, in emergencies only).
• Formulations:
• Regular Insulin: Short-acting, used pre-meal and in IV infusions.
• NPH Insulin: Intermediate-acting, for basal control.
• Adult & Pediatric Dosing: Individualized based on blood glucose, diet, and activity.
• Total Daily Dose (TDD): Typically 0.4–1.0 units/kg/day.
• Basal-Bolus Regimen: ~50% basal (NPH), ~50% bolus (Regular Insulin).
• Timing:
• Regular Insulin: Administer SC 30 minutes before meals.
• NPH: Once or twice daily for basal coverage.
• Continuous IV Infusion: For DKA or perioperative hyperglycemia; initial rate 0.1 units/kg/hr, adjust by glucose response.
• Special Populations:
• Renal/Hepatic Impairment: Dose reduction may be required due to reduced clearance.
• Elderly: Increased hypoglycemia risk; start low, titrate cautiously.

Insulin Human [rDNA] is a biosynthetic form of human insulin that mimics endogenous insulin action. It binds to insulin receptors on target cells (muscle, liver, adipose), activating receptor tyrosine kinase and initiating phosphorylation cascades. This enhances translocation of glucose transporter type 4 (GLUT4) to the cell surface, promoting glucose uptake. It also stimulates glycogen synthesis, inhibits hepatic gluconeogenesis, and reduces lipolysis and proteolysis, leading to decreased blood glucose and improved metabolic control.

• Absorption: Regular insulin: Onset 30–60 min after SC injection; NPH onset 1–2 hrs.
• Peak Action: Regular insulin: 2–4 hrs; NPH: 4–12 hrs.
• Duration: Regular insulin: 6–8 hrs; NPH: 12–18 hrs.
• Bioavailability: ~60–80% after SC injection.
• Distribution: Mainly in extracellular fluid; negligible protein binding.
• Metabolism: Primarily degraded by insulinases in the liver, kidneys, and muscle.
• Half-Life: Approximately 4–6 min in plasma, but biological effect longer due to receptor interaction.
• Elimination: Renal clearance of metabolites.

• Pregnancy: Classified as Category B (safe based on animal and human data). Commonly used to maintain maternal and fetal glycemic control.
• Lactation: Insulin appears in breast milk in small amounts but is not absorbed orally by the infant; considered safe.
• Caution: Frequent monitoring and dose adjustment required during pregnancy and postpartum.

• Primary Class: Antidiabetic agent.
• Subclass: Human Insulin (Short-acting or Intermediate-acting).

• Hypersensitivity to insulin human or formulation components.
• During episodes of hypoglycemia.
• Use in insulin pump for NPH formulation (risk of precipitation and clogging).

• Severe Hypoglycemia: Most common and dangerous adverse effect; monitor closely.
• Hypokalemia: Risk during IV infusion; monitor serum potassium.
• Illness or Stress: May require dose adjustment.
• Switching Insulin Types: Must be supervised to prevent glycemic instability.
• Injection Technique Errors: Risk of unpredictable absorption or lipodystrophy.

Common:

• Metabolic: Hypoglycemia (most frequent).
• Local: Injection site reactions (pain, erythema, lipohypertrophy).

Less Common:

• Weight gain.
• Peripheral edema.

Rare but Serious:

• Severe allergic reactions (generalized urticaria, anaphylaxis).
• Insulin resistance (rare, immune-mediated).

• Drugs Increasing Hypoglycemia Risk: Sulfonylureas, alcohol, salicylates, beta-blockers.
• Drugs Increasing Hyperglycemia Risk: Corticosteroids, diuretics, thyroid hormones, oral contraceptives.
• Beta-Blockers: May mask hypoglycemia symptoms.
• Alcohol: Can potentiate hypoglycemia.
• Enzyme Systems: Not metabolized by CYP450; interactions are pharmacodynamic.

• ADA Recommendations: Human insulin (Regular, NPH) still recommended for cost-sensitive patients or when analogs are not available.
• Shift Toward Analogs: Rapid-acting and long-acting analogs preferred for better glycemic control, but human insulin remains standard in many regions.
• Updates on Pump Use: Regular insulin allowed in some pump systems; NPH is not recommended for pumps.

• Unopened Vials/Pens: Store at 2°C to 8°C (refrigerated). Do not freeze.
• In-Use Vials: May be kept at room temperature (below 30°C) for up to 28 days.
• Protect from Light and Heat: Do not expose to direct sunlight.
• Do Not Shake: Roll gently to mix NPH suspension before injection.
• IV Solutions: Use promptly after preparation; discard unused solution.