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 moreThis 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 In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.
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
Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia. Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin. Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia. Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.
Therapeutic
Combination Oral hypoglycemic preparations
Storage Conditions
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.
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