Indications

Treatment of all patients with Type 1 Diabetes
Treatment of Type 2 Diabetes patients not adequately controlled by diet and/or oral hypoglycemic agents
Initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non‑ketotic syndrome, or during stress (infection, surgery)
Treatment of gestational diabetes

Composition

Strength	Contents per ml	Ratio
30/70	Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) — 30% Regular Insulin Human + 70% Isophane Insulin Human	30 : 70
50/50	Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) — 50% Regular Insulin Human + 50% Isophane Insulin Human	50 : 50

Pharmacology

Insulin lowers blood glucose by promoting cellular uptake of glucose and inhibiting hepatic glucose output.

Onset of action: within 30 minutes
Peak plasma level: 1 – 3 hours
Duration of action: approximately 10 – 24 hours

Dosage

Individualized by the physician according to patient needs.

Type 1 Diabetes: 0.5 – 1.0 IU/kg/day (maintenance therapy)
Type 2 Diabetes: usually lower, e.g. 0.3 – 0.6 IU/kg/day Injection should be followed within 30 minutes by a meal containing carbohydrates.

Administration

Administer subcutaneously in the abdominal wall, thigh, gluteal region, or deltoid. Rotate injection sites within the same region to avoid lipodystrophy. Avoid use if the cartridge is damaged, frozen, or not uniformly white and cloudy after mixing. Before use, roll the cartridge gently until the suspension appears uniformly white and cloudy.

Interactions

May reduce insulin requirement: oral hypoglycemics, MAO inhibitors, ACE inhibitors, salicylates, alcohol
May increase insulin requirement: thiazides, corticosteroids, thyroid hormones, β‑sympathomimetics, growth hormone
β‑blockers may mask hypoglycemia symptoms

Contraindications

Hypoglycemia
Hypersensitivity to human insulin or any excipient

Side Effects

Hypoglycemia — most common
Lipodystrophy at injection site
Allergic reactions: rash, itching, swelling, or rarely generalized hypersensitivity
Edema may occur transiently at therapy initiation

Pregnancy & Lactation

Insulin does not cross the placenta. It is safe during pregnancy and lactation. Insulin requirements may vary: lower in the first trimester, higher in the second and third, and return to baseline postpartum.

Precautions & Warnings

Inadequate dosing or discontinuation may lead to hyperglycemia or diabetic ketoacidosis. Dose adjustment may be required during illness, stress, or changes in diet or activity. Switching insulin type or brand should be done under medical supervision. Avoid use if clumps or solid particles are visible after mixing.

Overdose Effects

Mild hypoglycemia: treat with oral glucose or sugar
Severe hypoglycemia: treat with Glucagon 0.5–1 mg IM/SC or IV glucose by a healthcare professional After recovery, administer oral carbohydrates to prevent recurrence