Regulatory Class: ℞
Generic Name: Insulin glargine
Formulations: 100U/mL (3.64mg Insulin Glargine equivalent to 100U Human insulin)
Indications or Uses Diabetes Mellitus where treatment w/ insulin is required in adult, adolescent & childn ≥2 yr.
Dosage and Directions for Use: SC Individualized dosage. Administer once daily at the same time everyday. Dose & timing should be individually adjusted. Type 2 diabetes on oral antidiabetic agents Initially 10 IU once daily & subsequently adjusted individually.
Contraindication: Hypersensitivity.
Special Precaution: Not for the treatment of diabetic ketoacidosis. Hypoglycemia. Intercurrent illness. Renal & severe hepatic impairment. Monitor blood glucose regularly & require intensified metabolic monitoring. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn < 2 yr. Elderly.
Adverse Reaction: Hypoglycemia, temporary visual impairment, lipodystrophy, inj site & allergic reactions (eg, redness, pain, itching, hives, swelling & inflammation).
Interactions: May increase blood glucose lowering effect & susceptibility to hypoglycemia w/ oral antidiabetic products, ACE inhibitors, salicylates, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, sulfonamides. May reduce blood lowering effect w/ corticosteroids, danazol, diazoxide, diuretics, sympathomimetic agents (eg, epinephrine, salbutamol, terbutaline), glucagon, INH, phenothiazine derivates, somatropin, thyroid hormones, estrogens, progestogens (eg, OCs), PIs & atypical antipsychotic medications (eg, olanzapine & clozapine). Potentiated or weakened blood glucose lowering effect w/ β-blockers, clonidine, lithium salts & alcohol. Pentamidine may cause hypoglycemia, (sometimes) followed by hyperglycemia. Reduced or no signs of adrenergic counter regulation w/ β-blockers, clonidine, guanethidine & reserpine.
Presentation/Packaging: Solution for inj (pre-filled pen w/ cartridge) 100 u/mL x 3 mL x 5's .
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