EMPAPHAGE-M
EMPAGLIFLOZIN AND METFORMIN HCL · by MARTIN DOW MARKER
Composition
Tab 5mg/1000mg: Empagliflozin 5mg and Metformin HCI 1000mg, Tab 12.5mg/500mg: Empagliflozin 12.5mg and Metformin HCI 500mg, Tab 12.5mg/1000mg: Empagliflozin 12.5mg and Metformin HCI 1000mg
Indications & Dosage
Type 2 diabetes mellitus not controlled by metformin and/or a sulfonylurea with either empagliflozin or linagliptin: Adult 18-74 years: 10/5 mg once daily, increased to 25/5 mg once daily if necessary and if tolerated Adult 75 years and over: Initiation not recommended. Concomitant insulin dose needs to be reduced.
Contraindications
Diabetic ketoacidosis, severe hepatic impairment, severe renal impairment, acute conditions predisposing to renal impairment, acute metabolic acidosis or pre-coma, cardiac or respiratory failure, recent MI, alcoholism, pregnancy, lactation, and elderly (above 75yrs)
Precautions
Congestive heart failure and cardiovascular disease, hepatic impairment, renal impairment, complicated urinary tract infections; consider temporarily interrupting treatment. Avoid initiation if eGFR below 60 ml/minute/1.73m2. Avoid if eGFR is persistently below 45 ml/minute/1.73m2. Monitor renal function before starting treatment and regularly during treatment. Monitor electrolyte balance and ensure adequate hydration. Correct hypovolaemia before starting treatment. Consider interrupting treatment if volume depletion occurs, concomitant antihypertensive therapy or use of diuretics. Dose of concomitant insulin may need to be reduced.Iodinated contrast materials, discontinue for 48 hrs before and after elective surgery, assess risk factors and discontinue immediately if metabolic acidosis suspected. Monitor renal function at least annually.
Interactions
Diuretics, antihypertensive, UGT enzyme inducers, agents affecting renal functions, Alcohol, iodinated contrast agents, diuretics, corticosteroids, ACE inhibitors, NSAIDs, inhibitors of OCT1 & OCT2.
Pregnancy
Advised to avoid
Lactation
Advised to avoid
Side Effects
Genital infection, hypoglycaemia (in combination with insulin or sulfonylurea), polyuria, pruritus, urinary tract infection, dysuria, volume depletion (rare). Reports of altered LFTs, hepatitis, GI upset, taste disturbance, skin reactions, reduced B12 absorptions, abnormal liver function tests, rarely lactic acidosis