Apidra

Apidra

insulin glulisine

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Insulin glulisine
Indications/Uses
DM, where treatment w/ insulin is required, in adults, adolescents & childn ≥6 yr.
Dosage/Direction for Use
Individualized dose. Administer by IV inj, SC inj shortly (0-15 min) before or soon after meals, or continuous SC pump infusion. Administer in the abdominal wall, thigh or deltoid.
Administration
Should be taken with food.
Contraindications
Special Precautions
Caution when transferring to another type or brand of insulin. Perform continuous rotation of inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Monitor blood glucose after change in inj site & consider dose adjustment of antidiabetics. Inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia & diabetic ketoacidosis, which are potentially lethal. Risk of hypoglycaemia. Contains metacresol which may cause allergic reactions. Observe for signs & symptoms of heart failure, wt gain & oedema when used in combination w/ pioglitazone; discontinue pioglitazone if any deterioration in cardiac symptoms occurs. Always check insulin label before each inj to avoid medication errors between insulin glulisine & other insulins. Do not mix w/ glucose or Ringer's soln or w/ any other insulin when given by IV inj; w/ other medicinal products except NPH human insulin when given by SC inj; w/ diluents or any other insulin when used w/ an SC insulin infusion pump. Insulin requirements may be reduced in patients w/ renal or hepatic impairment. May impair ability to concentrate & react as a result of hypoglycaemia, hyperglycaemia, or visual impairment which may constitute risk when driving a car or operating machines. Careful monitoring of glucose control in pregnant women. Maintain good metabolic control throughout pregnancy in patients w/ pre-existing or gestational diabetes. Breast-feeding mothers may require adjustments in insulin dose & diet. Insufficient clinical information in childn <6 yr. Limited pharmacokinetic data in elderly patients w/ DM.
Adverse Reactions
Hypoglycaemia. Inj site & local hypersensitivity reactions.
Drug Interactions
Blood glucose-lowering activity may be enhanced & susceptibility to hypoglycaemia increased w/ oral antidiabetics, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulphonamide antibiotics. Blood glucose-lowering activity may be reduced w/ corticosteroids, danazol, diazoxide, diuretics, glucagon, INH, phenothiazine derivatives, somatropin, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, oestrogens, progestins (eg, in OCs), PIs & atypical antipsychotics (eg, olanzapine & clozapine). Blood glucose-lowering activity may either be potentiated or weakened w/ β-blockers, clonidine, lithium salts or alcohol. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. Signs of adrenergic counter-regulation may be reduced or absent w/ sympatholytics eg, β-blockers, clonidine, guanethidine & reserpine.
MIMS Class
Insulin Preparations
ATC Classification
A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Form
Apidra soln for inj 3.49 mg/mL (100 u/mL)
Packing/Price
10 mL x 1's (P1,240/box)