Empadus-M
Generic Name
Empagliflozin 5 mg and Metformin Hydrochloride
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empadus m 5 mg tablet | ৳ 22.00 | ৳ 132.00 |
Description
Overview of the medicine
Empadus-M 5 mg Tablet is a combination medication containing Empagliflozin and Metformin, used to improve glycemic control in adults with type 2 diabetes mellitus. It also offers cardiovascular and renal benefits.
Uses & Indications
Dosage
Adults
Individualized. Typically, Empagliflozin 5 mg/Metformin (e.g., 500 mg or 1000 mg) once or twice daily, depending on prior therapy and tolerability. Max Empagliflozin 25 mg/day, Max Metformin 2000 mg/day.
Elderly
Dose adjustment based on renal function. Caution advised due to increased risk of lactic acidosis with Metformin.
Renal_impairment
Contraindicated if eGFR <30 mL/min/1.73m². Dose adjustment required for eGFR 30-60 mL/min/1.73m².
How to Take
Take orally with meals to reduce gastrointestinal side effects of Metformin. Swallow whole, do not crush or chew.
Mechanism of Action
Empagliflozin inhibits SGLT2 in the kidneys, reducing glucose reabsorption and increasing glucose excretion in urine. Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity.
Pharmacokinetics
Onset
Glucose lowering effect within hours.
Excretion
Empagliflozin: Primarily via urine (approx. 50%) and feces (approx. 50%). Metformin: Primarily via urine.
Half life
Empagliflozin: Approximately 12.4 hours. Metformin: Approximately 4-9 hours.
Absorption
Empagliflozin: Rapidly absorbed, peak plasma concentration (Cmax) reached within 1.5 hours. Metformin: Slowly and incompletely absorbed, Tmax 2-3 hours for immediate-release and 4-8 hours for extended-release.
Metabolism
Empagliflozin: Primarily metabolized by glucuronidation. Metformin: Not metabolized, excreted unchanged.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis
- Known hypersensitivity to empagliflozin or metformin
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- History of serious hypersensitivity reaction to empagliflozin or metformin hydrochloride or any excipients in the formulation.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis associated with metformin.
Diuretics
May increase risk of dehydration and hypotension, especially with empagliflozin.
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia. Dose adjustment may be necessary.
Cationic drugs (e.g., Cimetidine, Ranolazine, Dofetilide)
May increase Metformin systemic exposure by competing for renal tubular transport.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Management includes supportive measures. Hemodialysis can remove Metformin. Empagliflozin is not dialyzable.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the second and third trimesters. Caution during lactation; Metformin passes into breast milk, and empagliflozin's effects on the breastfed infant are unknown.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis
- Known hypersensitivity to empagliflozin or metformin
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- History of serious hypersensitivity reaction to empagliflozin or metformin hydrochloride or any excipients in the formulation.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis associated with metformin.
Diuretics
May increase risk of dehydration and hypotension, especially with empagliflozin.
Insulin and Insulin Secretagogues (e.g., sulfonylureas)
Increased risk of hypoglycemia. Dose adjustment may be necessary.
Cationic drugs (e.g., Cimetidine, Ranolazine, Dofetilide)
May increase Metformin systemic exposure by competing for renal tubular transport.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Management includes supportive measures. Hemodialysis can remove Metformin. Empagliflozin is not dialyzable.
Pregnancy & Lactation
Not recommended during pregnancy, especially in the second and third trimesters. Caution during lactation; Metformin passes into breast milk, and empagliflozin's effects on the breastfed infant are unknown.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Under patent
Clinical Trials
Extensive clinical trials (e.g., EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved) have demonstrated efficacy in glycemic control and cardiovascular/renal benefits for empagliflozin, often in combination with metformin.
Lab Monitoring
- Renal function (eGFR) before initiation and periodically thereafter.
- Glycemic control (HbA1c, fasting plasma glucose).
- Vitamin B12 levels periodically (Metformin can cause deficiency).
- Liver function tests (baseline).
- Electrolytes if lactic acidosis is suspected.
Doctor Notes
- Counsel patients on signs of ketoacidosis (nausea, vomiting, abdominal pain, breath odor, rapid breathing).
- Temporarily discontinue before imaging procedures requiring iodinated contrast media and for surgical procedures.
- Monitor renal function regularly. Consider vitamin B12 supplementation if deficiency is suspected with long-term Metformin use.
Patient Guidelines
- Take exactly as prescribed.
- Maintain a balanced diet and regular exercise.
- Stay well-hydrated.
- Report any signs of serious side effects (e.g., severe abdominal pain, unusual muscle pain, difficulty breathing).
- Inform your doctor if you need surgery or any diagnostic procedure involving iodinated contrast dyes (Metformin needs to be temporarily stopped).
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or low blood sugar (especially if used with other antidiabetics), which can affect ability to drive or operate machinery. Exercise caution.
Lifestyle Advice
- Adopt a healthy diet low in sugar and refined carbohydrates.
- Engage in regular physical activity.
- Monitor blood glucose levels regularly.
- Limit alcohol intake.
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Global Brand Names
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