Company: Boehringer Ingelheim Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Empagliflozin 10mg, 25mg.
Description: Round or oval, pale yellow, biconvex, film-coated tablets marked S10 or S25 on one side and Boehringer Ingelheim logo on reverse, respectively.
Presentation: 28, €38.89.
Indications: Treatment of type 2 diabetes mellitus. As monotherapy when diet and exercise alone do not provide adequate glycaemic control (when metformin is considered inappropriate) or as an add-on combination therapy in combination with other glucose–lowering agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Pharmacology: Empagliflozin is a reversible, highly potent and selective sodium-glucose co-transporter 2 inhibitor. It improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. The mechanism of action is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Dosage: Adult: Swallow whole with water. 10mg once daily, may increase to maximum 25mg daily. In combination with a sulphonylurea (SU) or insulin, consider a lower dose of SU or insulin. Renal impairment: 10mg once daily. Elderly: 85 years and older, not recommended. Children: Safety and efficacy not established.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Pregnancy, lactation.
Special precautions: Do not use for type 1 diabetes, diabetic ketoacidosis, end stage renal disease, patients on dialysis or initiate if cc<60 ml/min. Not recommended: Severe hepatic impairment. Caution: Cardiovascular disease, history of hypotension (and concomitant anti‑hypertensives), elderly (≥75 years). Monitor renal function prior to initiation of treatment (and at least yearly thereafter) or concomitant drugs reducing renal function; discontinue if cc<45 ml/min. Conditions leading to fluid loss; monitor volume status and electrolytes. Consider temporary interruption until fluid loss corrected or if complicated urinary tract infections occur. Cardiac failure NYHA class I-II (limited experience); NYHA class III-IV (no experience). Hepatic injury reported. Contains lactose. Driving/using machines (avoid hypoglycaemia).
Drug interactions: Avoid: UGT enzymes inducers. Thiazide and loop diuretics. Positive urine test for glucose.
Adverse drug reactions: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection, urinary tract infection, hypoglycaemia (when used with SU or insulin), pruritus, increased urination.
Full prescribing information and references available from Boehringer Ingelheim Ltd. Telephone: (01) 2959620. E-mail: medinfo.bra@boehringer-ingelheim.com
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