Empatab M(Empagliflozin 5 mg & Metformin HCl 500 mg)
Therapeutic Group: Sodium-glucose Co-transporter 2 inhibitor
Presentation
EmpatabTM M 5/500: Each tablet contains Empagliflozin INN 5 mg and Metformin Hydrochloride BP 500 mg.
Description
Empagliflozin (Sodium-glucose co-transporter-2 inhibitor) and Metformin (biguanide) is a combination of two oral antihyperglycemic drugs with complimentary mechanism of action to improve glycemic control in patients with type-2 diabetes mellitus. Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion and Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Indications
Combination of Empagliflozin and Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Metformin is appropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
Dosage & Administration
The starting dose of Empagliflozin and Metformin formulation is individualized based on the patients current Regimen. The maximum recommended total daily dose is 25 mg Empagliflozin and 2000 mg Metformin Hydrochloride. It should take twice daily with a meal, dose should be increase gradually to reduce the gastrointestinal side effects due to metformin.
Empagliflozin and Metformin should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.
Side Effects
Urinary tract infection and female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache etc.
Precautions
• Lactic acidosis: This can occur due to Metformin accumulation during treatment with Empagliflozin & Metformin.
• Before initiating Empagliflozin & Metformin combination, volume status should be assessed and correction on hypovolemia should be made in the elderly, in patients with renal impairment, in patients with low systolic blood pressure and in patients on diuretics since Empagliflozin causes intravascular volume contraction.
• Empagliflozin increases serum creatinine and decreases eGFR so before initiation of therapy with Empagliflozin and Metformin and during therapy renal function need to monitor routinely.
• In patients taking insulin or an insulin secretagogue with Empagliflozin and Metformin, a lower dose of insulin or the insulin secretagogue is considered to reduce the risk of hypoglycemia.
• Genital mycotic infections: Monitoring and treatment should be done if indicated.
• Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Monitor hematologic parameters annually may required.
• Increased LDL-C: Monitor and treat as appropriate.
Use in Pregnancy & Lactation
Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters.
Lactation: Empagliflozin and Metformin is not recommended when breastfeeding.
Drug Interaction
• Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring.
• Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use.
• Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake.
Over Dose
In the event of an overdose with Empagliflozin and Metformin contact the Doctor. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of empagliflozin by hemodialysis has not been studied. However, metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful partly for removal of accumulated metformin from patients in whom Empagliflozin and Metformin overdosage is suspected.
Storage
Do not store above 30 C. Keep out of the reach of children.
Commercial Pack
EmpatabTM M 5/500: Each box contains 3 blister strips of 10 tablets.
