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

Indications

Insulin Lispro (25%/50%) + Insulin Lispro Protamine (75%/50%) mix is used for: Diabetes mellitus

Adult Dose

Subcutaneous Diabetes Mellitus 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 wkly basis according to blood glucose levels. Dose should not be increased if there is hypoglycaemic episode (<70 mg/dl) during a 3-day period.

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment: Dose adjustments may be required.

Administration

Administer SC BID (ie, before breakfast and evening meal); each dose intended to cover 2 meals or a meal and snack Inject SC into abdominal wall, thigh, or upper arm

Contra Indications

Hypoglycaemia. Hypersensitivity to any of the components.

Precautions

Renal or hepatic impairment; pregnancy, lactation; transferring from other insulin. Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile. Concomitant illness esp infections. Lactation: Unknown whether distributed in breast milk; compatible with breast feeding, but lactating women may require dosage adjustment; caution advised

Pregnancy-Lactation

Pregnancy The limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes; published studies during pregnancy have not reported association between drug and induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications; also increases fetal risk for major birth defects, still birth, and macrosomia related morbidity Animal data Pregnant rats and rabbits exposed to drug during organogenesis showed no adverse effects on embryo/fetal viability or morphology in offsprings administered a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day; no adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.24 times the human subcutaneous dose of 1 unit/kg/day Lactation There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; one small published study reported exogenous insulin present in human milk; however, there is insufficient information to determine effects on breastfed infant and no available information on the effects on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for insulin, any potential adverse effects on breastfed child from drug or from underlying maternal condition

Interactions

Effects may be increased by: oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics. Effects may be decreased by: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, oral contraceptives, lithium. Signs of hypoglycaemia may be masked by beta-blockers, clonidine.

Adverse Effects

Side effects of Insulin Lispro (25%/50%) + Insulin Lispro Protamine (75%/50%) mix : Hypoglycaemia; hypokalemia, oedema; pruritus; pulpitation, nausea, rash; hypersensitivity reactions; lipoatropy or lipohypertrophy with SC Inj.

Mechanism of Action

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.