Company: Sanofi.
Legal category: Prescription. GMS reimbursable. Sport prohibited.
Active ingredient: Insulin glargine 300 units/ml.
Description: Solution for injection in SoloStar pre-filled pen.
Presentation: 5 x 1.5ml, €61.61.
Indication: Treatment of diabetes mellitus in adults.
Pharmacology: Insulin glargine is a human insulin analogue with a low solubility at neutral pH. After injection into subcutaneous tissue, acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released. Insulin lowers blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Dosage: Adult: Administer by once-daily subcutaneous injection in abdominal wall, the deltoid or thigh preferably at same time each day. 1-80 units per injection, in 1 unit steps. Adjust dose individually. Rotate injection sites. Units are not interchangeable with IU or other insulin analogue units. Type 1 diabetes: Must combine with short-/rapid-acting insulin to cover mealtime insulin requirements. Type 2 diabetes: Can take with other anti-hyperglycaemics. Starting dose, 0.2 units/kg. Elderly: As per adults. Children: Under 18 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 or infusion pumps. 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), see SPC. Closely monitor where warning 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 increase insulin requirements: Oral contraceptives, thyroid hormones, sympathomimetics, danazol, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, atypical antipsychotics, protease inhibitors. Substances that may decrease insulin requirements: Oral anti-diabetics, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, salicylates, sulphonamides, disopyramide, fibrates, fluoxetine, pentoxifylline, propoxyphene. Beta-blockers, clonidine, lithium salts, alcohol, pentamidine, sympatholytics.
Adverse drug reactions: Hypoglycaemia, lipohypertrophy, injection site reactions.
Full prescribing information and references available from Sanofi. Telephone: 01 4035600.
E-mail: iemedinfo@sanofi.com