sanofi-aventis

[Natrapharm]

Regulatory Class: Rx

C: Insulin glargine

I: DM where treatment w/ insulin is required in adult, adolescent & childn ≥2 yr.

D: 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.

CI: Hypersensitivity.

SP: 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.

AR: Hypoglycemia, temporary visual impairment, lipodystrophy, inj site & allergic reactions (eg, redness, pain, itching, hives, swelling & inflammation).

INT: 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.

P/P: Soln for inj (pre-filled pen w/ cartridge) 100 u/mL x 3 mL x 5's.

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