EXEMPA-LIN MET XR

*Type 2 diabetes mellitus not controlled by either empagliflozin or linagliptin with metformin alone:* Adult 18-74 years: Tab 10/5/1000 mg once daily, increased to Tab 25/5 mg/1000 mg once daily if necessary and if tolerated. Alternatively Tab 12.5/2.5/1000 mg twice daily if tolerated. Maximum recommended daily dose is Empagliflozin 25 mg, Linagliptin 5 mg and Metformin HCl 2000 mg. Adult 75 years and over: Initiation not recommended. Concomitant insulin dose needs to be reduced.

Severe renal impairment, end-stage renal disease or dialysis, hypersensitivity to the drugs. Diabetic ketoacidosis, severe hepatic impairment, acute conditions predisposing to renal impairment, Metabolic acidosis, including diabetic ketoacidosis or Type 1 diabetes mellitus.

Renal impairment, hepatic impairment, elderly, congestive heart failure and cardiovascular disease, complicated urinary tract infections; consider temporarily interrupting treatment. 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.Iodinated contrast materials, discontinue for 48 hrs before and after elective surgery, assess risk factors and discontinue immediately if metabolic acidosis suspected. If a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. If metformin-associated lactic acidosis is suspected, immediately discontinue and start general supportive measures. Prompt hemodialysis is recommended.

Diuretics, antihypertensive, UGT enzyme inducers, agents affecting renal functions, potent CYP3A4 and P-gp inducer Alcohol, iodinated contrast agents, corticosteroids, ACE inhibitors, NSAIDs, inhibitors of OCT1 & OCT2.

Pancreatitis, heart failure, hypotension, ketoacidosis, acute kidney injury, urosepsis and pyelonephritis, hypoglycemia, pancreatitis, necrotizing fasciitis of the perineum (fourniers gangrene), genital mycotic infections, polyuria, pruritus, urinary tract infection, dysuria, reduced B12 absorptions, abnormal liver function tests. Metformin-associated lactic acidosis may result in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset is minute and with nonspecific symptoms e.g., malaise, myalgias, respiratory distress, somnolence, and abdominal pain.