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Other brands with the same active ingredient
These brands contain the same active ingredient (Empagliflozin + Metformin Hydrochloride). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Emaglin - M 5/500
Rx5 mg • Tablet
Indications & Uses
Emaglin - M 5/500 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
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. Extended-release formulations: Individualize starting dose based on the patient’s current drug regimen. Take film coated tablet twice daily with meal and extended-release formulations should be taken once daily with meal, with gradual dose escalation to reduce the Gl adverse effects due to Metformin. Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of Metformin Hydrochloride 2000 mg and Empagliflozin 25 mg.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.
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.
Cautions & Contraindications
Warnings & Precautions
Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of Diampa M. Hypotension: Before initiating Diampa M assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected. Ketoacidosis: Before initiating Diampa M assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue Diampa M, evaluate and treat promptly. Acute kidney injury & impairment in renal function: Consider temporarily discontinuing Diampa M in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue Diampa M promptly and institute treatment. Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating Diampa M. Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually. Increased LDL-C: Monitor and treat as appropriate. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Diampa M.
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