Company: Eli Lilly and Co (Ireland) Ltd.
Legal category: Prescription. GMS reimbursable. Sport prohibited.
Active ingredient: Insulin glargine 100 units/ml.
Description: Solution for injection.
Presentation: 5 x 3ml cartridges, €45.80; 5 x 3ml KwikPen, €45.80.
Indications: Treatment of diabetes mellitus.
Pharmacology: Insulin glargine is a human insulin analogue with low solubility at neutral pH. After injection into subcutaneous tissue, acidic solution is neutralised leading to formation of microprecipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Dosage: Adult: Administer subcutaneously once daily at the same time each day. Adjust dose individually. Can be given with orally active antidiabetics in type 2 patients. Units are not interchangeable with IU or other insulin analogue units. Elderly: As per adults. Children: 2 years and older, as per adults. Under 2 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special precautions: Not for diabetic ketoacidosis. Do not administer by intravenous injection. Caution: Significant stenoses of coronary arteries or of blood vessels supplying the brain, proliferative retinopathy. Hepatic/ renal impairment, insufficient glucose control, tendency to hyper- or hypoglycaemic episodes. Transition from other insulins requires strict medical supervision (may require dose adjustment). Closely monitor where warnings signs of hypoglycaemia are reduced, e.g. markedly improved glycaemic control, gradual development of hypoglycaemia, elderly, transfer from animal insulin to human insulin, autonomic neuropathy, long history of diabetes, psychiatric illness. Closely monitor factors increasing susceptibility to hypoglycaemia (may require dose adjustment), e.g. change in injection area, improved insulin sensitivity, unaccustomed/ increased/ prolonged physical activity, intercurrent illness (requires intensified metabolic monitoring), inadequate food intake, missed meals, certain uncompensated endocrine disorders. Normal or decreased values for glycated haemoglobin (consider possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia). Driving/using machines (avoid hypoglycaemia). Pregnancy.
Drug interactions: Caution: Pioglitazone (patients with cardiac heart failure risk factors). Substances that may enhance the blood-glucose-lowering effect include oral antidiabetics, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin anologues, sulphonamides. Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogen, progestogen, phenothiazine derivatives, somatropin, sympathomimetics, thyroid hormones, atypical antipsychotics, protease inhibitors, beta-blockers, clonidine, lithium salts, alcohol, pentamidine, guanethidine, reserpine.
Adverse drug reactions: Hypoglycaemia, lipohypertrophy, injection site reactions.
Full prescribing information and references available from Eli Lilly and Co (Ireland) Ltd. Telephone: +353 1 664 0446.
E-mail: ukmedinfo@lilly.com.