Empaglif-M
Generic Name
Empagliflozin and Metformin Hydrochloride Tablet
Manufacturer
Boehringer Ingelheim / Eli Lilly and Company
Country
Germany / USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empaglif m 5 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Empagliflozin and Metformin Hydrochloride is a combination oral antidiabetic medication used to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Metformin is a biguanide.
Uses & Indications
Dosage
Adults
Initial dose is Empagliflozin 5 mg and Metformin 500 mg orally twice daily with meals. Dosage may be titrated based on efficacy and tolerability, up to a maximum of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (depending on available strengths).
Elderly
No specific dose adjustment based solely on age, but renal function should be assessed before initiation and monitored regularly.
Renal_impairment
Not recommended for patients with eGFR < 30 mL/min/1.73 m². Dose adjustment required for eGFR 30-60 mL/min/1.73 m² (Metformin contraindicated below 30 mL/min/1.73 m²; Empagliflozin may have reduced efficacy).
How to Take
Take orally, twice daily with meals to reduce gastrointestinal side effects associated with metformin.
Mechanism of Action
Empagliflozin inhibits SGLT2 in the renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin primarily reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Glucose-lowering effects observed within hours of administration.
Excretion
Empagliflozin: Renal and fecal. Metformin: Primarily renal, unchanged.
Half life
Empagliflozin: approx. 12.4 hours. Metformin: approx. 6.2 hours (plasma).
Absorption
Empagliflozin: Rapidly absorbed, Cmax within 1.5 hours. Metformin: Slowly absorbed, Cmax within 2-3 hours.
Metabolism
Empagliflozin: Primarily by glucuronidation. Metformin: Negligibly metabolized.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- History of lactic acidosis with metformin.
- Liver impairment.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin.
Loop Diuretics
May increase risk of dehydration and hypotension, and potentially impair renal function, especially with empagliflozin.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis (with metformin).
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia, may require dose adjustment.
Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim, isavuconazole, vandetanib)
May increase metformin levels and risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin could lead to hypoglycemia (especially with concomitant insulin/sulfonylurea), dehydration, and electrolyte imbalances. Metformin overdose can lead to lactic acidosis, which is a medical emergency. Treatment includes supportive measures, symptomatic treatment, and possibly hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the fetus from empagliflozin. Metformin data are conflicting; generally, insulin is preferred for glycemic control during pregnancy. Avoid use during lactation as it is unknown if empagliflozin or metformin passes into breast milk.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- History of lactic acidosis with metformin.
- Liver impairment.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin.
Loop Diuretics
May increase risk of dehydration and hypotension, and potentially impair renal function, especially with empagliflozin.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis (with metformin).
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia, may require dose adjustment.
Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim, isavuconazole, vandetanib)
May increase metformin levels and risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin could lead to hypoglycemia (especially with concomitant insulin/sulfonylurea), dehydration, and electrolyte imbalances. Metformin overdose can lead to lactic acidosis, which is a medical emergency. Treatment includes supportive measures, symptomatic treatment, and possibly hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the fetus from empagliflozin. Metformin data are conflicting; generally, insulin is preferred for glycemic control during pregnancy. Avoid use during lactation as it is unknown if empagliflozin or metformin passes into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date
Availability
Available in pharmacies and hospitals worldwide
Approval Status
Approved by FDA and other regulatory bodies worldwide
Patent Status
Under patent protection (Empagliflozin component); Metformin is off-patent
Clinical Trials
Multiple pivotal clinical trials (e.g., EMPA-REG OUTCOME) have demonstrated the efficacy and cardiovascular benefits of empagliflozin, both alone and in combination with metformin. These trials led to its approval for reducing cardiovascular risk.
Lab Monitoring
- Renal function (eGFR) prior to initiation and annually (more frequently in elderly or those with impaired renal function)
- HbA1c levels
- Blood glucose levels
- Lipid profile
- Electrolytes (e.g., serum bicarbonate in patients at risk for lactic acidosis)
Doctor Notes
- Counsel patients on the symptoms of lactic acidosis and ketoacidosis.
- Emphasize adequate hydration.
- Monitor renal function regularly, especially in vulnerable populations.
- Consider temporary discontinuation in cases of acute illness, surgery, or procedures requiring contrast agents.
Patient Guidelines
- Take medicine exactly as prescribed by your doctor.
- Take with meals to minimize gastrointestinal upset.
- Maintain adequate hydration by drinking plenty of fluids.
- Report any signs of lactic acidosis (e.g., unusual muscle pain, difficulty breathing, unusual stomach discomfort, dizziness, feeling cold) or ketoacidosis (e.g., nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing) immediately to your doctor.
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one. Continue with your regular dosing schedule.
Driving Precautions
This medicine usually does not impair the ability to drive or operate machinery. However, if hypoglycemia occurs (especially when used with insulin or sulfonylureas), vision or concentration may be affected. Patients should be aware of their response before driving or operating machinery.
Lifestyle Advice
- Maintain a balanced diet and regular exercise regimen.
- Monitor blood glucose levels regularly as advised by your doctor.
- Limit alcohol consumption.
- Stay well-hydrated, especially during illness, strenuous exercise, or in hot weather.
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