Insulin Human [rDNA]

Insulin Human (rDNA) is a sterile, clear, colorless solution produced by recombinant DNA technology. It is a fast-acting insulin with a relatively short duration of action compared with other insulins. It lowers blood glucose by binding to insulin receptors, facilitating glucose uptake in muscle and fat cells, and inhibiting glucose output from the liver.

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus (not adequately controlled by diet and/or oral hypoglycemic agents)
• Diabetic ketoacidosis
• Hyperosmolar non-ketotic syndrome
• Gestational diabetes

Adult Dose (Subcutaneous):

• Type 1 Diabetes: 0.5-1.0 units/kg/day; prepubertal children: 0.7-1.0 units/kg/day
• Type 2 Diabetes: 0.3-0.6 units/kg/day (initial)
• Higher doses may be required in insulin-resistant patients (puberty or obesity)
• Meal or snack containing carbohydrates should follow within 30 minutes of injection

Renal and Hepatic Impairment: Insulin requirements may be reduced

Side Effects:

• Hypoglycemia
• Lipodystrophy (due to failure to rotate injection sites)
• Generalized hypersensitivity (skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, breathing difficulties, palpitation, reduced blood pressure) - potentially life-threatening
• Edema (upon initiation of insulin therapy, usually transient)

Precautions:

• Inadequate dosing or discontinuation of treatment (especially type 1) may lead to hyperglycemia; untreated hyperglycemia may lead to diabetic ketoacidosis (potentially lethal)
• Hypoglycemia may occur if insulin dose is too high in relation to insulin requirement
• Transferring to another type or brand of insulin should be done under strict medical supervision
• Changes in strength, brand, type, species and/or method of manufacture may result in need for dosage change
• Consult doctor before traveling between different time zones

Contraindications:

• Hypoglycemia
• Hypersensitivity to human insulin or any excipients

Drug Interactions:

• Oral hypoglycemic agents (OHA), MAOIs, nonselective beta-blockers, ACE inhibitors, salicylates, alcohol reduce insulin requirements
• Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, danazol increase insulin requirements
• Beta-blockers may mask symptoms of hypoglycemia and delay recovery
• Octreotide/lanreotide may both increase and decrease insulin requirement
• Alcohol may intensify and prolong hypoglycemic effect of insulin

Use in Pregnancy: Insulin does not cross placental barrier; insulin requirements fall in 1st trimester, increase in 2nd and 3rd; return to pre-pregnancy values after delivery; both hypoglycemia and hyperglycemia increase risk of fetal malformations and death.

Use in Lactation: Insulin treatment of nursing mother involves no risk to baby; however insulin dosage, diet or both may need adjustment.

Renal Impairment: Renal impairment may reduce insulin requirements; dose adjustment may be needed.

Hepatic Impairment: Hepatic impairment may reduce insulin requirements; dose adjustment may be needed.

Overdose: No specific overdose definition for insulin; hypoglycemia may develop; mild episodes treated with oral glucose or sugary products; severe episodes with glucagon (0.5-1 mg) IM/SC or IV glucose; oral carbohydrate recommended after regaining consciousness.