Empalina
Generic Name
Empalina 25 mg tablet
Manufacturer
Innovate Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empalina 25 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Empalina 25 mg tablet is an oral medication used to lower blood glucose levels in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in certain adult patients.
Uses & Indications
Dosage
Adults
The recommended starting dose is 10 mg once daily, taken in the morning, with or without food. If additional glycemic control is needed and the 10 mg dose is well-tolerated, the dose may be increased to 25 mg once daily.
Elderly
No dose adjustment is recommended based on age alone. However, renal function should be assessed before initiating and periodically during treatment.
Renal_impairment
Not recommended for initiation in patients with eGFR < 20 mL/min/1.73m². In patients with eGFR ≥ 20 mL/min/1.73m², the dose does not need to be adjusted, but monitoring is recommended.
How to Take
Take orally once daily in the morning, with or without food. Swallow the tablet whole with water; do not crush, split, or chew.
Mechanism of Action
Empalina selectively inhibits the sodium-glucose co-transporter 2 (SGLT2) in the renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. This leads to a reduction in blood glucose levels independently of insulin. It also has diuretic and natriuretic effects.
Pharmacokinetics
Onset
Within 30 minutes of administration (glucosuric effect).
Excretion
Approximately 50% renally excreted and 50% fecally excreted, mainly as inactive metabolites.
Half life
Approximately 12 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1-2 hours.
Metabolism
Primarily metabolized in the liver via glucuronidation (UGT1A3, UGT1A8, UGT1A9, UGT2B7).
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Severe renal impairment (eGFR < 20 mL/min/1.73m²), end-stage renal disease, or patients on dialysis.
Drug Interactions
Diuretics
May increase the risk of dehydration and hypotension.
Insulin and Sulfonylureas
May increase the risk of hypoglycemia. A lower dose of insulin or sulfonylurea may be required.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to dehydration, electrolyte imbalances, and severe hypoglycemia (if taken with insulin/sulfonylureas). Management includes symptomatic and supportive measures. Hemodialysis is not expected to be effective.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Avoid during lactation as it is unknown if it is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Severe renal impairment (eGFR < 20 mL/min/1.73m²), end-stage renal disease, or patients on dialysis.
Drug Interactions
Diuretics
May increase the risk of dehydration and hypotension.
Insulin and Sulfonylureas
May increase the risk of hypoglycemia. A lower dose of insulin or sulfonylurea may be required.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to dehydration, electrolyte imbalances, and severe hypoglycemia (if taken with insulin/sulfonylureas). Management includes symptomatic and supportive measures. Hemodialysis is not expected to be effective.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Avoid during lactation as it is unknown if it is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by regulatory authorities for use in Type 2 Diabetes Mellitus and Heart Failure
Patent Status
Under patent protection
Clinical Trials
Extensive phase III clinical trials (EMPOWER-CV, EMPOWER-RENAL) demonstrated efficacy in glycemic control and cardiovascular/renal outcomes. Post-marketing surveillance is ongoing.
Lab Monitoring
- Renal function (eGFR) should be assessed prior to initiation and periodically thereafter.
- Glycemic control (HbA1c, fasting plasma glucose) to monitor effectiveness.
Doctor Notes
- Counsel patients on proper hydration to mitigate risk of volume depletion.
- Educate on symptoms of DKA and Fournier's gangrene; emphasize immediate medical attention if these occur.
- Regularly monitor eGFR and adjust concomitant therapies (e.g., diuretics, insulin).
Patient Guidelines
- Take Empalina exactly as prescribed by your doctor.
- Stay well-hydrated by drinking adequate fluids.
- Be aware of symptoms of urinary tract infections or genital yeast infections and report them to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once.
Driving Precautions
Empalina has no or negligible influence on the ability to drive and use machines. However, patients should be advised to take precautions to avoid hypoglycemia, especially if used in combination with insulin or sulfonylureas.
Lifestyle Advice
- Maintain a healthy diet and regular exercise routine as advised by your healthcare provider.
- Monitor blood glucose levels regularly.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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