Toujeo

Insulin glargine

DM in adults, adolescents & childn from 6 yr.

SC Individualized dose. Administer once daily, at any time during the day, preferably at the same time every day. Type 1 DM Once daily w/ meal-time insulin. Type 2 DM Initially 0.2 U/kg once daily followed by individual dose adjustments.

Hypersensitivity.

Discontinue pioglitazone if any deterioration in cardiac symptoms occurs. Not for treatment of diabetic ketoacidosis. Not to be inj into areas of lipodystrophy or localized cutaneous amyloidosis. Not to be mixed w/ any other insulin products. Not to be diluted. Not intended for IV & via insulin infusion pump. Never use syringe to remove drug from SoloStar pre-filled pen into syringe; not to re-use needles. Occurrence of hypoglycemia in patients w/ significant stenoses of coronary arteries or of blood vessels supplying brain & proliferative retinopathy, particularly if not treated w/ photocoagulation; sudden change in inj site to unaffected area. Possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycemia if normal or decreased values for glycated Hb occurs. Increased susceptibility to hypoglycemia in presence of factors eg, change in inj area; increased insulin sensitivity (eg, by removal of stress factors); unaccustomed, increased, or prolonged physical exercise; intercurrent illness (eg, vomiting, diarrhoea); inadequate food intake; alcohol consumption; certain uncompensated endocrine disorders; concomitant treatment w/ certain medications. Patients in whom glycemic control is markedly improved; hypoglycemia develops gradually; transferring from animal to human insulin; where an autonomic neuropathy is present; w/ long history of diabetes; suffering from psychiatric illness; receiving concurrent treatment w/ certain other drugs. Patients w/ risk factors for development of cardiac heart failure. May delay recovery from hypoglycemia due to prolonged effect of SC treatment. May cause insulin Abs. Instruct patients on appropriate diabetes self-management skills, including glucose monitoring, proper inj technique, & hypo-/hyperglycemia management; handling special situations eg, inadequate or skipped insulin dose, inadvertent administration of increased insulin dose, inadequate food intake or skipped meals; to perform continuous rotation of inj site. Patient should comply w/ dosage & dietary regimen, correct insulin administration & awareness of hypoglycemia symptoms. Correct hypoglycemia by immediate carbohydrate intake. Intensified metabolic monitoring in patients w/ intercurrent illness. Perform urine tests for ketones. Switching between treatment & insulin glargine 100 U/mL, & other insulins. May affect ability to drive & use machines. Renal & severe hepatic impairment. Maintain good metabolic control throughout pregnancy in patients w/ pre-existing or gestational diabetes. Adjust insulin dose & diet during lactation. Childn <6 yr. Progressive renal function may lead to steady decrease in insulin requirements in elderly.

Hypoglycemia; temporary visual impairment, diabetic retinopathy; lipohypertrophy; local allergy at inj site eg, redness, pain, itching, hives, swelling or inflammation. Generalised skin reactions, angioedema, bronchospasm, hypotension & anaphylactic shock.

Increased blood glucose lowering effect w/ antihyperglycemics, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics. Reduced blood glucose lowering effect w/ corticosteroids, danazol, diazoxide, diuretics, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens & progestogens (eg, OCs), PIs & atypical antipsychotics (eg, olanzapine & clozapine). Either potentiated or weakened blood glucose lowering effect w/ β-blockers, clonidine, lithium salts & alcohol. Concomitant use w/ pentamidine. Reduced or absence of adrenergic counterregulation signs w/ sympatholytics eg, β-blockers, clonidine, guanethidine & reserpine.

Insulin Preparations

A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.

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