Insulin Lispro (25%/50%) + Insulin Lispro Protamine (75%/50%) mix

Insulin Lispro Protamine & Insulin Lispro mix is a combination containing 75% insulin lispro protamine suspension and 25% insulin lispro injection (or 50/50 formulation). Insulin lispro is a short-acting biosynthetic human insulin analogue. Insulin lispro protamine is an intermediate-acting glucose-lowering agent; it is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation. They are used together for the regulation of glucose metabolism.

• Control of hyperglycemia in patients with diabetes mellitus

Adult Dose (Subcutaneous):

• Combination rapid-onset (faster than regular insulin) and intermediate-acting insulins in fixed dose
• Dose regimen varies among patients depending on metabolic needs; typical daily insulin requirements range between 0.5-1 unit/kg
• Initially, 10 units with the largest meal of the day; dose adjustments may be made on a weekly basis according to blood glucose levels
• Dose should not be increased if there is hypoglycemic episode during a 3-day period

Child Dose: Safety and efficacy not established

Side Effects:

• Hypoglycemia
• Hypokalemia
• Edema
• Pruritus
• Palpitations
• Nausea
• Rash
• Hypersensitivity reactions
• Lipoatrophy or lipohypertrophy (with SC injection)

Precautions:

• Caution in renal or hepatic impairment
• Caution in pregnancy and lactation
• Caution when transferring from other insulin
• Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile
• Caution in concomitant illness, especially infections
• Lactation: Unknown whether distributed in breast milk; caution advised

Contraindications:

• Hypoglycemia
• Hypersensitivity to insulin lispro or any excipients

Drug Interactions:

• Oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, salicylates, somatostatin analog, sulfonamide antibiotics increase effect
• Corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, oral contraceptives, lithium decrease effect
• Beta-blockers, clonidine may mask signs of hypoglycemia

Use in Pregnancy: Category B; animal studies have failed to demonstrate risk to fetus; no adequate and well-controlled studies in pregnant women.

Use in Lactation: Unknown whether distributed in breast milk; compatible with breast feeding, but lactating women may require dosage adjustment; caution advised.

Renal Impairment: Dose adjustments may be required; regular blood glucose monitoring recommended.

Hepatic Impairment: Dose adjustments may be required; regular blood glucose monitoring recommended.

Overdose: Excess insulin may cause hypoglycemia and hypokalemia; mild episodes treated with oral glucose; severe episodes (coma, seizure, neurologic impairment) treated with IM/SC glucagon or IV glucose; hypokalemia must be corrected appropriately.