Generic
Empagliflozin + Metformin Hydrochloride
Indications
This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise: In patients insufficiently controlled on their maximally tolerated dose of Metformin alone In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products ... Read more
Pharmacology
Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion. Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Dosage Administration
The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg. Recommended individualized starting dose: In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride. In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin. In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component. In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination. Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m2 is contraindicated. Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Contraindications
Hypersensitivity to Empagliflozin and Metformin Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR <30 ml/min) Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock Hepatic impairment, acute alcohol intoxication, alcoholism
Side Effects
Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below: Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased Rare: Diabetic ketoacidosis.
Pregnancy And Lactation
Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.
Therapeutic
Combination Oral hypoglycemic preparations
Storage Conditions
Keep below 30�C temperature, protected from light & moisture. Keep out of the reach of children.
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