Empaglif-M
Generic Name
Empagliflozin and Metformin Hydrochloride
Manufacturer
Boehringer Ingelheim & Eli Lilly
Country
Germany/USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empaglif m 125 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Empaglif-M is a combination oral antidiabetic drug containing empagliflozin (an SGLT2 inhibitor) and metformin hydrochloride (a biguanide). It is used to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of cardiovascular death, heart failure hospitalization, and kidney disease progression in specific patient populations.
Uses & Indications
Dosage
Adults
The usual starting dose is Empagliflozin 5 mg / Metformin 500 mg once daily, adjusted based on efficacy and tolerability. For this strength (Empagliflozin 12.5 mg / Metformin 1000 mg), it is typically taken orally twice daily with meals. Max daily dose: Empagliflozin 25 mg / Metformin 2000 mg.
Elderly
Dose adjustments may be needed based on renal function. Caution is advised due to potential for decreased renal function and increased risk of lactic acidosis. Renal function should be monitored frequently.
Renal_impairment
Contraindicated in severe renal impairment (eGFR < 30 mL/min/1.73m²). Dose adjustments are needed for eGFR 30-60 mL/min/1.73m² (Metformin dosage limitation). Empagliflozin is not recommended to initiate if eGFR < 20 mL/min/1.73m² for glycemic control. If eGFR falls below 30 mL/min/1.73m² during treatment, discontinue.
How to Take
Take orally twice daily with meals to reduce the gastrointestinal side effects associated with metformin.
Mechanism of Action
Empagliflozin selectively inhibits the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Empagliflozin: Glycosuric effect observed within 30 minutes. Metformin: Glucose lowering effect within hours, maximal effect after several days of continuous administration.
Excretion
Empagliflozin: Approximately 50% renally excreted and 50% fecally excreted. Metformin: Excreted predominantly unchanged in the urine. Renal clearance is 3.5 times higher than creatinine clearance, indicating tubular secretion.
Half life
Empagliflozin: Terminal elimination half-life is approximately 13.2 hours. Metformin: Plasma elimination half-life is approximately 4-9 hours.
Absorption
Empagliflozin: Rapidly absorbed, peak plasma concentration (Cmax) within 1.5 hours. Metformin: Slowly and incompletely absorbed, Tmax 2-3 hours (immediate release) or 4-8 hours (extended release). Bioavailability of Metformin is 50-60%.
Metabolism
Empagliflozin: Primarily metabolized by glucuronidation via uridine 5'-diphospho-glucuronosyltransferases (UGT) UGT1A3, UGT1A8, UGT1A9, and UGT2B7. Metformin: Excreted unchanged in the urine; no hepatic metabolism has been observed.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis (DKA)
- History of serious hypersensitivity reaction to empagliflozin or metformin
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in fasting or malnourished patients.
Diuretics (e.g., thiazides, loop diuretics)
May increase the risk of dehydration and hypotension with empagliflozin. May also impair renal function, increasing risk of lactic acidosis with metformin.
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or sulfonylurea may be required.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis with metformin.
Drugs that affect renal tubular transport of metformin (e.g., cimetidine, ranolazine, dolutegravir)
May increase systemic exposure to metformin, increasing the risk of lactic acidosis.
Storage
Store below 30°C (86°F) in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Empagliflozin overdose leads to increased urinary glucose excretion. Metformin overdose can lead to lactic acidosis. Management is symptomatic and supportive. Hemodialysis can remove metformin, but empagliflozin is unlikely to be removed by dialysis.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Metformin is considered Category B, Empagliflozin is Category C. Lactation: Not recommended. Both empagliflozin and metformin are excreted in breast milk.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis (DKA)
- History of serious hypersensitivity reaction to empagliflozin or metformin
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in fasting or malnourished patients.
Diuretics (e.g., thiazides, loop diuretics)
May increase the risk of dehydration and hypotension with empagliflozin. May also impair renal function, increasing risk of lactic acidosis with metformin.
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or sulfonylurea may be required.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis with metformin.
Drugs that affect renal tubular transport of metformin (e.g., cimetidine, ranolazine, dolutegravir)
May increase systemic exposure to metformin, increasing the risk of lactic acidosis.
Storage
Store below 30°C (86°F) in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Empagliflozin overdose leads to increased urinary glucose excretion. Metformin overdose can lead to lactic acidosis. Management is symptomatic and supportive. Hemodialysis can remove metformin, but empagliflozin is unlikely to be removed by dialysis.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Metformin is considered Category B, Empagliflozin is Category C. Lactation: Not recommended. Both empagliflozin and metformin are excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
FDA/DGDA Approved
Patent Status
Under patent protection (original formulation), generics available in some markets
Clinical Trials
Empagliflozin has been extensively studied in large clinical trials such as EMPA-REG OUTCOME, EMPEROR-Reduced, and EMPEROR-Preserved, demonstrating significant cardiovascular and renal benefits. Metformin has a long history of clinical evidence for glycemic control.
Lab Monitoring
- Renal function (eGFR) before initiation and at least annually thereafter (more frequently in elderly or impaired renal function).
- HbA1c and blood glucose levels regularly.
- Liver function tests periodically.
- Vitamin B12 levels periodically, especially in patients on long-term metformin therapy or with risk factors for deficiency.
Doctor Notes
- Counsel patients on the symptoms of lactic acidosis and DKA; emphasize seeking immediate medical attention if these symptoms occur.
- Monitor renal function closely, especially before initiation and during concurrent use with agents that may impair renal function.
- Advise patients on adequate hydration, particularly during illness or before surgical procedures.
- Consider vitamin B12 supplementation for patients on long-term metformin therapy, especially those with anemia or peripheral neuropathy.
Patient Guidelines
- Take Empaglif-M exactly as prescribed by your doctor, usually twice daily with meals.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
- Maintain a balanced diet and regular exercise as advised by your healthcare provider.
- Monitor your blood glucose levels regularly as instructed.
- Report any unusual symptoms such as extreme tiredness, severe stomach pain, unusual muscle pain, or difficulty breathing, as these could be signs of serious side effects like lactic acidosis or DKA.
- Stay well-hydrated to reduce the risk of dehydration and kidney problems.
Missed Dose Advice
If a dose is missed, take it as soon as you remember with food. If it is almost time for your next dose, 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
This medicine may cause dizziness or hypoglycemia (especially when used with insulin or sulfonylureas), which could impair your ability to drive or operate machinery. Exercise caution until you know how it affects you.
Lifestyle Advice
- Adhere to a diabetes management plan that includes diet and exercise.
- Limit or avoid alcohol consumption, as it can increase the risk of lactic acidosis.
- Ensure adequate fluid intake to prevent dehydration, especially during illness or in hot weather.
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