Empamet
Generic Name
empamet-125-mg-tablet
Manufacturer
MediCorp Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empamet 125 mg tablet | ৳ 31.00 | ৳ 248.00 |
Description
Overview of the medicine
Empamet 125 mg Tablet is a combination medicine containing Empagliflozin and Metformin Hydrochloride, used to improve glycemic control in adults with type 2 diabetes mellitus. It works by reducing glucose reabsorption in the kidneys and decreasing hepatic glucose production while improving insulin sensitivity.
Uses & Indications
Dosage
Adults
The usual starting dose of Empagliflozin is 10 mg once daily. Metformin dosage is individualized based on efficacy and tolerability, typically starting at 500 mg once or twice daily, up to a maximum of 2000 mg/day. For Empamet 125 mg Tablet (Empagliflozin 10mg + Metformin 125mg), one tablet orally once or twice daily with meals, as directed by physician.
Elderly
No specific dose adjustment is recommended based on age; however, renal function should be assessed before initiation and monitored regularly.
Renal_impairment
Not recommended in patients with eGFR < 30 mL/min/1.73 m². Dose adjustment may be needed for eGFR 30-60 mL/min/1.73 m². Metformin is contraindicated in severe renal impairment.
How to Take
Take orally, with meals, to reduce gastrointestinal side effects associated with Metformin. Swallow the tablet whole; do not crush, cut, or chew.
Mechanism of Action
Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which reduces renal glucose reabsorption and increases urinary glucose excretion. Metformin is a biguanide that reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Within hours for blood glucose lowering effects.
Excretion
Empagliflozin: Approximately 50% renally, 50% fecally. Metformin: Primarily renally excreted as unchanged drug.
Half life
Empagliflozin: Approximately 12.4 hours. Metformin: Approximately 6.2 hours.
Absorption
Empagliflozin: Rapidly absorbed, peak plasma concentrations reached within 1.5 hours. Metformin: Slowly and incompletely absorbed, peak plasma concentrations reached within 2.5 hours (immediate release). Bioavailability of Metformin is 50-60%.
Metabolism
Empagliflozin: Extensively metabolized by glucuronidation. Metformin: Not metabolized; excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin, Metformin, or any excipients.
- 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.
- Known history of lactic acidosis.
- Severe dehydration, acute heart failure, acute myocardial infarction, severe infection, or conditions predisposing to lactic acidosis.
Drug Interactions
Alcohol
Increases risk of lactic acidosis with Metformin.
Diuretics
Increased risk of dehydration and hypotension, especially with loop diuretics.
Rifampicin
May decrease Empagliflozin exposure.
Carbonic Anhydrase Inhibitors
May increase risk of lactic acidosis with Metformin.
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia; dose adjustment may be required.
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 dehydration. Metformin overdose can lead to lactic acidosis, characterized by symptoms like malaise, myalgia, respiratory distress, and abdominal pain. Management involves supportive measures, correction of dehydration, and for severe lactic acidosis, hemodialysis may be necessary to remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the second and third trimesters. It is not known whether components are excreted in human milk; consider discontinuing nursing or the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin, Metformin, or any excipients.
- 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.
- Known history of lactic acidosis.
- Severe dehydration, acute heart failure, acute myocardial infarction, severe infection, or conditions predisposing to lactic acidosis.
Drug Interactions
Alcohol
Increases risk of lactic acidosis with Metformin.
Diuretics
Increased risk of dehydration and hypotension, especially with loop diuretics.
Rifampicin
May decrease Empagliflozin exposure.
Carbonic Anhydrase Inhibitors
May increase risk of lactic acidosis with Metformin.
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia; dose adjustment may be required.
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 dehydration. Metformin overdose can lead to lactic acidosis, characterized by symptoms like malaise, myalgia, respiratory distress, and abdominal pain. Management involves supportive measures, correction of dehydration, and for severe lactic acidosis, hemodialysis may be necessary to remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the second and third trimesters. It is not known whether components are excreted in human milk; consider discontinuing nursing or the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved (Hypothetical for this specific strength combination)
Patent Status
Patent protected (Brand name 'Empamet')
Clinical Trials
Clinical trials for Empagliflozin/Metformin combinations have shown significant reductions in HbA1c, body weight, and cardiovascular events in patients with type 2 diabetes. The EMPA-REG OUTCOME trial demonstrated cardiovascular benefits of Empagliflozin.
Lab Monitoring
- Renal function (eGFR) before initiation and periodically thereafter.
- HbA1c levels regularly.
- Fasting and postprandial glucose levels.
- Vitamin B12 levels periodically with long-term Metformin use.
Doctor Notes
- Emphasize the importance of diet and exercise alongside medication.
- Educate patients on symptoms of hypoglycemia, lactic acidosis, and urinary/genital infections.
- Monitor renal function periodically, especially in elderly patients.
- Advise patients to stay well-hydrated.
- Consider discontinuing Metformin in conditions predisposing to lactic acidosis (e.g., severe infection, dehydration).
Patient Guidelines
- Follow diet and exercise recommendations provided by your doctor.
- Drink adequate fluids to prevent dehydration, especially during illness or hot weather.
- Report any signs of serious side effects, such as unusual muscle pain, difficulty breathing, or severe stomach pain, to your doctor immediately.
- Monitor blood glucose regularly as advised.
Missed Dose Advice
If a dose is missed, 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 double the dose.
Driving Precautions
Empamet 125 mg Tablet itself is not expected to affect the ability to drive or operate machinery. However, if used in combination with insulin or sulfonylureas, the risk of hypoglycemia may increase, which can impair concentration and reaction time. Patients should be aware of hypoglycemia symptoms.
Lifestyle Advice
- Maintain a balanced diet low in refined carbohydrates and sugars.
- Engage in regular physical activity as tolerated.
- Avoid excessive alcohol consumption.
- Quit smoking if applicable.
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