Empaglif-M 25/1000 XR Tablet
Rx25 mg • Xr Tablet
Indications & Uses
Empaglif-M 25/1000 XR Tablet is indicated for:
Pharmacology
Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the main transporter that takes glucose from the kidney back into the circulation. When Empagliflozin blocks SGLT2, the kidney reabsorbs less of the glucose it has filtered, and the renal threshold for glucose falls. As a result, more glucose leaves the body in the urine.
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, and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production and decreases intestinal absorption of glucose. It also improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The dose of this Empagliflozin and Metformin Hydrochloride combination should be set for each patient, based on how well it works and how well it is tolerated. Take it twice daily with meals. Raise the dose gradually, so the gastrointestinal side effects caused by Metformin Hydrochloride are reduced. The maximum recommended daily dose is 2000 mg for Metformin Hydrochloride and 25 mg for Empagliflozin.
For the starting dose, the choice depends on what the patient already takes. A patient on Metformin Hydrochloride switches to the combination containing Empagliflozin 5 mg, with a similar total daily dose of Metformin Hydrochloride. A patient on Empagliflozin switches to the combination containing Metformin Hydrochloride 500 mg, with a similar total daily dose of Empagliflozin. A patient already treated with Empagliflozin and Metformin Hydrochloride as separate medicines switches to the combination with the same total daily dose of each. If a patient has volume depletion and hasn't been treated with Empagliflozin before, correct this before starting the combination.
For extended-release formulations, the starting dose depends on the patient's current drug regimen. The film coated tablet is taken twice daily with a meal. The extended-release formulation is taken once daily with a meal. In both cases the dose goes up gradually, to reduce the GI adverse effects of Metformin. Adjust the dose according to effectiveness and tolerability, and don't go above the maximum recommended daily dose of Metformin Hydrochloride 2000 mg and Empagliflozin 25 mg.
In patients with impaired kidney function, assess renal function before starting the combination. It is contraindicated in patients with an eGFR below 45 mL/min/1.73 m2.
For pediatric patients under 18 years of age, safety and effectiveness have not been established.
Side Effects
With Empagliflozin + Metformin Hydrochloride, the most common side effects of Empagliflozin (5% or greater incidence) are urinary tract infection and genital mycotic (fungal) infections in women. For Metformin (>5%), the most common ones are diarrhea, nausea or vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache. The other important side effects are grouped below by how often they occur. Very common are hypoglycemia (when used with a sulphonylurea or insulin) and gastrointestinal symptoms. Common are vaginal moniliasis, vulvovaginitis, balanitis and other genital infection, and also urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, generalised pruritus, rash, increased urination and increased serum lipids. Uncommon are volume depletion, urticaria, dysuria, increased blood creatinine or decreased glomerular filtration rate, and increased haematocrit. Rare is diabetic ketoacidosis.
Cautions & Contraindications
Warnings & Precautions
Lactic acidosis: Cases of lactic acidosis linked to Metformin Hydrochloride have been reported after the medicine came on the market. If lactic acidosis is suspected, stop Empagliflozin + Metformin Hydrochloride immediately and start general supportive measures promptly in a hospital. Hypotension: Before starting this medicine, assess and correct the volume status of patients with renal impairment, the elderly, patients with low systolic blood pressure and patients on diuretics. After starting, watch for signs and symptoms of hypotension, and monitor more closely in situations where volume contraction is expected. Ketoacidosis: Before starting treatment, assess any patient who shows signs and symptoms of metabolic acidosis for ketoacidosis, whatever the blood glucose level. If ketoacidosis is suspected, stop the medicine, then evaluate and treat promptly. Acute kidney injury and impairment in renal function: Consider stopping the medicine temporarily when oral intake is reduced or fluid is being lost. If acute kidney injury occurs, stop it promptly and start treatment. Urosepsis, Pyelonephritis, Fournier's gangrene and Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk of urinary tract infections. Check patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. Hypoglycemia: When starting this medicine, consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Vitamin B12 deficiency: Metformin Hydrochloride may lower vitamin B12 levels, so monitor hematologic parameters annually. Increased LDL-C: Monitor and treat as appropriate. Macrovascular outcomes: No clinical studies have established conclusive evidence that Empagliflozin + Metformin Hydrochloride reduces macrovascular risk.
Contraindications
Empagliflozin + Metformin Hydrochloride should not be used in people who are hypersensitive to empagliflozin or metformin. It is also not for anyone with any type of acute metabolic acidosis (such as lactic acidosis or diabetic ketoacidosis), or with diabetic pre-coma. Severe renal failure (GFR <30 ml/min) is another contraindication. So are acute conditions that could alter renal function, such as dehydration, severe infection and shock. The same applies to disease that may cause tissue hypoxia, especially acute disease or a worsening of chronic disease. Examples are decompensated heart failure, respiratory failure, recent myocardial infarction and shock. Hepatic impairment, acute alcohol intoxication and alcoholism are also contraindications.
Pregnancy & Breastfeeding
Women should be told that Empagliflozin + Metformin Hydrochloride may carry a risk to the baby in the womb, especially in the second and third trimesters. It is not recommended while breastfeeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
In controlled clinical studies, healthy volunteers took single doses of Empagliflozin up to 800 mg (equal to 32 times the highest recommended daily dose), and patients with type 2 diabetes took multiple daily doses up to 100 mg (equal to 4 times the highest recommended daily dose). Neither showed any toxicity. With Metformin, hypoglycaemia has not been seen at doses up to 85 g, but lactic acidosis has occurred in such cases. Lactic acidosis is a medical emergency and must be treated in hospital.
If an overdose happens, treatment should be started according to the patient's clinical status. Haemodialysis is the most effective way to remove lactate and Metformin. Whether haemodialysis removes Empagliflozin has not been studied.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Empagliflozin + Metformin Hydrochloride below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Empaglif-M 25/1000 XR Tablet 25 mg
What is Empaglif-M 25/1000 XR Tablet 25 mg Xr Tablet?
Empaglif-M 25/1000 XR Tablet 25 mg Xr Tablet is a medicine that contains Empagliflozin + Metformin Hydrochloride. It is made by Aristopharma Limited. It belongs to the Combination Oral hypoglycemic preparations group of medicines.
What is Empaglif-M 25/1000 XR Tablet used for?
Empaglif-M 25/1000 XR Tablet is used for: Type 2 Diabetes Mellitus, Diabetes Mellitus.
What are the side effects of Empaglif-M 25/1000 XR Tablet?
With Empagliflozin + Metformin Hydrochloride, the most common side effects of Empagliflozin (5% or greater incidence) are urinary tract infection and genital mycotic (fungal) infections in women. For Metformin (>5%), the most common ones are diarrhea, nausea or vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache.
Can I take Empaglif-M 25/1000 XR Tablet during pregnancy or while breastfeeding?
Women should be told that Empagliflozin + Metformin Hydrochloride may carry a risk to the baby in the womb, especially in the second and third trimesters. It is not recommended while breastfeeding. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Empaglif-M 25/1000 XR Tablet?
In controlled clinical studies, healthy volunteers took single doses of Empagliflozin up to 800 mg (equal to 32 times the highest recommended daily dose), and patients with type 2 diabetes took multiple daily doses up to 100 mg (equal to 4 times the highest recommended daily dose). Neither showed any toxicity. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Empaglif-M 25/1000 XR Tablet?
Store Empagliflozin + Metformin Hydrochloride below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Empaglif-M 25/1000 XR Tablet?
Some medicines can interact with Empagliflozin + Metformin Hydrochloride, for example: Isoniazid, Cimetidine, Ranolazine, Empagliflozin, Vandetanib, Phenytoin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Empaglif-M 25/1000 XR Tablet?
Empaglif-M 25/1000 XR Tablet is a prescription (Rx) medicine. Take it as your doctor advises.