Empamet XR
Generic Name
Empagliflozin and Metformin Hydrochloride Extended-Release Tablet
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empamet xr 5 mg tablet | ৳ 25.00 | ৳ 200.00 |
Description
Overview of the medicine
Empamet XR is a combination medicine containing Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Metformin Hydrochloride, a biguanide. It is used to improve glycemic control in adults with type 2 diabetes mellitus.
Uses & Indications
Dosage
Adults
The usual starting dose is one Empagliflozin 5 mg/Metformin XR 500 mg tablet orally once daily with a meal. Dosage may be increased gradually based on effectiveness and tolerability, up to a maximum of Empagliflozin 25 mg/Metformin XR 2000 mg daily.
Elderly
No specific dose adjustment is required based on age alone. However, renal function should be assessed before initiation and periodically thereafter due to increased risk of renal impairment in elderly patients.
Renal_impairment
Not recommended for use in patients with eGFR below 30 mL/min/1.73 m². Dose adjustments are required for Metformin component based on eGFR; consider discontinuing if eGFR falls below 30 mL/min/1.73 m².
How to Take
Take orally once daily with a meal, preferably in the morning. Swallow the tablet whole; do not crush, cut, or chew it. Taking with food helps to reduce gastrointestinal side effects associated with Metformin.
Mechanism of Action
Empagliflozin works by inhibiting SGLT2 in the kidneys, which reduces glucose reabsorption and increases urinary glucose excretion. Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Empagliflozin: Glycemic reduction observed within hours. Metformin: Full glycemic effect typically achieved within days to 2 weeks.
Excretion
Empagliflozin: Approximately 54.4% excreted in feces and 41.2% in urine. Metformin: Primarily excreted unchanged in urine.
Half life
Empagliflozin: Approximately 12.4 hours. Metformin: Approximately 4-9 hours.
Absorption
Empagliflozin is rapidly absorbed after oral administration, with peak plasma concentrations reached in 1.5 hours. Metformin XR is slowly absorbed, with peak plasma concentrations occurring 4-8 hours post-dose. Bioavailability of Empagliflozin is approximately 78%. Metformin bioavailability is 50-60%.
Metabolism
Empagliflozin is primarily metabolized by glucuronidation. Metformin is excreted unchanged in the urine; it is not metabolized in humans.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- Metabolic acidosis, including diabetic ketoacidosis (DKA), with or without coma
- Known hypersensitivity to empagliflozin or metformin or any other component of the tablet
- Acute or chronic metabolic acidosis
Drug Interactions
Alcohol
Potentiates the effect of Metformin on lactate metabolism, increasing the risk of lactic acidosis.
Iodinated Contrast Agents
Temporarily discontinue Metformin before or at the time of an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure and restart Metformin if renal function is stable.
Diuretics (e.g., Thiazides, Loop diuretics)
May increase the risk of volume depletion and hypotension.
Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Cationic drugs (e.g., Amiloride, Digoxin, Morphin, Procainamide)
May compete with Metformin for renal tubular transport, potentially increasing Metformin levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin may lead to increased urinary glucose excretion, diuresis, and potential volume depletion. Metformin overdose can lead to lactic acidosis, which is a medical emergency. Treatment is symptomatic and supportive; hemodialysis may be useful for Metformin removal.
Pregnancy & Lactation
Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the fetus. Not recommended during breastfeeding as both empagliflozin and metformin are excreted in human milk.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- Metabolic acidosis, including diabetic ketoacidosis (DKA), with or without coma
- Known hypersensitivity to empagliflozin or metformin or any other component of the tablet
- Acute or chronic metabolic acidosis
Drug Interactions
Alcohol
Potentiates the effect of Metformin on lactate metabolism, increasing the risk of lactic acidosis.
Iodinated Contrast Agents
Temporarily discontinue Metformin before or at the time of an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure and restart Metformin if renal function is stable.
Diuretics (e.g., Thiazides, Loop diuretics)
May increase the risk of volume depletion and hypotension.
Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Cationic drugs (e.g., Amiloride, Digoxin, Morphin, Procainamide)
May compete with Metformin for renal tubular transport, potentially increasing Metformin levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin may lead to increased urinary glucose excretion, diuresis, and potential volume depletion. Metformin overdose can lead to lactic acidosis, which is a medical emergency. Treatment is symptomatic and supportive; hemodialysis may be useful for Metformin removal.
Pregnancy & Lactation
Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the fetus. Not recommended during breastfeeding as both empagliflozin and metformin are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, check product label for exact expiry.
Availability
Available in pharmacies
Approval Status
Approved (e.g., FDA, DGDA)
Patent Status
Patented (Empagliflozin component), Generic (Metformin component)
Clinical Trials
Empagliflozin and Metformin combination has been extensively studied in various clinical trials, demonstrating efficacy in glycemic control and significant cardiovascular and renal benefits in patients with type 2 diabetes. Key trials include EMPA-REG OUTCOME and EMPEROR-Preserved/Reduced.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiating Empamet XR and periodically thereafter, especially in elderly patients and those with risk factors for renal impairment.
- Blood glucose and HbA1c levels should be monitored regularly to assess glycemic control.
- Vitamin B12 levels should be measured periodically in patients on long-term Metformin therapy, especially those with risk factors for deficiency.
Doctor Notes
- Prioritize patient education on symptoms of lactic acidosis and genitourinary infections.
- Emphasize the importance of hydration, especially during illness or before procedures involving iodinated contrast.
- Regularly monitor renal function (eGFR), HbA1c, and B12 levels.
- Consider de-escalation of concomitant insulin or sulfonylurea to mitigate hypoglycemia risk.
Patient Guidelines
- Take Empamet XR exactly as prescribed by your doctor.
- Swallow the tablet whole; do not crush, cut, or chew.
- Take with a meal, preferably in the morning, to minimize stomach upset.
- Stay well-hydrated, especially during illness or in hot weather, to reduce the risk of dehydration.
- Report any signs of lactic acidosis (e.g., unusual muscle pain, trouble breathing, stomach pain, dizziness, weakness) or genitourinary infections to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Empamet XR alone is not expected to cause hypoglycemia and therefore should not impair the ability to drive or operate machinery. However, if used in combination with other anti-diabetic agents that cause hypoglycemia (e.g., insulin, sulfonylureas), patients should be warned about the risk of hypoglycemia and advised to take precautions.
Lifestyle Advice
- Maintain a balanced diet that is appropriate for managing type 2 diabetes.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood glucose levels regularly as instructed.
- Limit or avoid alcohol consumption to reduce the risk of lactic acidosis.
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