Empadus
Generic Name
Empagliflozin 10 mg Tablet
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
empadus 10 mg tablet | ৳ 25.00 | ৳ 350.00 |
Description
Overview of the medicine
Empadus 10 mg Tablet contains Empagliflozin, an SGLT2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus. It also reduces the risk of cardiovascular death, heart failure hospitalization, and progression of kidney disease in specific patient populations.
Uses & Indications
Dosage
Adults
Initial dose is 10 mg once daily in the morning, with or without food. May be increased to 25 mg once daily if additional glycemic control is needed and 10 mg is well tolerated. For cardiovascular/renal indications, 10 mg once daily is the recommended dose.
Elderly
No dose adjustment is required based on age alone. Caution is advised due to potential for volume depletion.
Renal_impairment
Initiation not recommended if eGFR < 20 mL/min/1.73m². If eGFR falls below 20 mL/min/1.73m² during treatment, continue 10 mg dose. No dose adjustment needed for mild to moderate impairment. For severe impairment (eGFR < 30 mL/min/1.73m²), consider specific guidelines; it is effective down to eGFR of 20 mL/min/1.73m² for heart failure and kidney disease indications.
How to Take
Take orally once daily in the morning, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Empagliflozin selectively inhibits the sodium-glucose co-transporter 2 (SGLT2) in the renal proximal tubules, reducing glucose reabsorption and increasing urinary glucose excretion, thereby lowering blood glucose levels. It also leads to mild osmotic diuresis and natriuresis.
Pharmacokinetics
Onset
Glycemic effect within hours, full therapeutic effect within days/weeks.
Excretion
Approximately 41% excreted in feces and 54% in urine, mainly as inactive metabolites. Renal clearance of unchanged drug is low.
Half life
Approximately 12.4 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations (Cmax) reached within 1.5 hours.
Metabolism
Primarily metabolized by glucuronidation via UGT enzymes (UGT1A3, UGT1A8, UGT1A9, UGT2B7, UGT2B15).
Side Effects
Contraindications
- History of serious hypersensitivity reaction to empagliflozin or any excipients
- Patients on dialysis
Drug Interactions
Lithium
SGLT2 inhibitors may decrease serum lithium concentrations. Monitor serum lithium levels more frequently.
Diuretics
Co-administration with diuretics may increase the risk of dehydration and hypotension.
Insulin or Insulin Secretagogues
May increase the risk of hypoglycemia. A lower dose of insulin or secretagogue may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. If overdose occurs, supportive treatment should be initiated as dictated by the patient’s clinical status. Empagliflozin is not expected to be dialyzable.
Pregnancy & Lactation
Pregnancy: Use is not recommended during the second and third trimesters. Lactation: Not recommended. Discontinue the drug or discontinue nursing, considering the importance of the drug to the mother.
Side Effects
Contraindications
- History of serious hypersensitivity reaction to empagliflozin or any excipients
- Patients on dialysis
Drug Interactions
Lithium
SGLT2 inhibitors may decrease serum lithium concentrations. Monitor serum lithium levels more frequently.
Diuretics
Co-administration with diuretics may increase the risk of dehydration and hypotension.
Insulin or Insulin Secretagogues
May increase the risk of hypoglycemia. A lower dose of insulin or secretagogue may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. If overdose occurs, supportive treatment should be initiated as dictated by the patient’s clinical status. Empagliflozin is not expected to be dialyzable.
Pregnancy & Lactation
Pregnancy: Use is not recommended during the second and third trimesters. Lactation: Not recommended. Discontinue the drug or discontinue nursing, considering the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by FDA, DGDA
Patent Status
Patent held by original innovator, generics available post-expiry or through licensing in some regions
Clinical Trials
Key trials include EMPA-REG OUTCOME (cardiovascular outcomes), EMPEROR-Reduced and EMPEROR-Preserved (heart failure), and EMPA-KIDNEY (chronic kidney disease).
Lab Monitoring
- Renal function (eGFR) before initiation and periodically thereafter
- Glycemic control (HbA1c)
- Lipid profile (baseline and as needed)
- Electrolytes (if volume depletion is a concern)
Doctor Notes
- Emphasize patient education on hydration and signs of UTIs/genital infections.
- Monitor renal function before and during therapy, especially in susceptible populations.
- Consider dose adjustment of concomitant insulin/sulfonylureas to mitigate hypoglycemia risk.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Stay well-hydrated, especially during illness or hot weather.
- Be aware of symptoms of urinary tract infections or genital yeast infections and report them to your doctor.
- Monitor your blood glucose regularly as advised by your doctor.
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 take your next dose at the regular time. Do not take a double dose to make up for a missed dose.
Driving Precautions
Empagliflozin generally has no or negligible influence on the ability to drive and use machines. However, patients should be advised of the risk of hypoglycemia when used in combination with insulin or sulfonylureas, and of symptoms of volume depletion like dizziness.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity.
- Avoid excessive alcohol consumption.
- Regularly monitor blood sugar and follow up with your doctor.
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