Empalina
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 |
|---|---|---|
| empalina 10 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Empalina 10 mg Tablet contains Empagliflozin, an SGLT2 inhibitor. It is used to lower blood sugar in adults with type 2 diabetes mellitus, reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and treat heart failure (HFrEF and HFpEF) and chronic kidney disease.
Uses & Indications
Dosage
Adults
Initial dose is 10 mg once daily, preferably in the morning. May be increased to 25 mg once daily based on glycemic control and tolerability.
Elderly
No dose adjustment based solely on age. Monitor renal function prior to initiation and periodically thereafter.
Renal_impairment
Initial dose 10 mg once daily. Not recommended for initiation in patients with eGFR <20 mL/min/1.73m². If eGFR falls below 20, continue existing dose under strict medical supervision.
How to Take
Take orally once daily, in the morning, with or without food.
Mechanism of Action
Empagliflozin inhibits sodium-glucose co-transporter 2 (SGLT2) in the renal tubules, reducing glucose reabsorption from the glomerular filtrate and increasing urinary glucose excretion. This leads to a reduction in blood glucose levels, blood pressure, and body weight.
Pharmacokinetics
Onset
Glucose-lowering effects typically observed within hours of administration.
Excretion
Approximately 50% renally excreted (as unchanged drug and metabolites) and approximately 50% fecally excreted.
Half life
Approximately 12.4 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached approximately 1.5 hours post-dose.
Metabolism
Extensively metabolized, primarily via glucuronidation by UGT1A8, UGT1A9, and UGT2B7.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin or any component of the formulation.
- Patients with severe renal impairment (eGFR <20 mL/min/1.73m²), end-stage renal disease, or on dialysis.
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension.
ACE Inhibitors/Angiotensin Receptor Blockers (ARBs)
Potential for additive hypotensive effects.
Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia when co-administered. 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
In case of an overdose, symptomatic and supportive treatment should be initiated. Empagliflozin is not removed by dialysis.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on fetal renal development. Not recommended during lactation as empagliflozin is excreted in milk in rats and potential risks to breastfed infants are unknown.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin or any component of the formulation.
- Patients with severe renal impairment (eGFR <20 mL/min/1.73m²), end-stage renal disease, or on dialysis.
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension.
ACE Inhibitors/Angiotensin Receptor Blockers (ARBs)
Potential for additive hypotensive effects.
Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia when co-administered. 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
In case of an overdose, symptomatic and supportive treatment should be initiated. Empagliflozin is not removed by dialysis.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on fetal renal development. Not recommended during lactation as empagliflozin is excreted in milk in rats and potential risks to breastfed infants are unknown.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Generics available
Clinical Trials
Key clinical trials for Empagliflozin include EMPA-REG OUTCOME (cardiovascular outcomes in T2DM), EMPEROR-Reduced and EMPEROR-Preserved (heart failure), and EMPA-KIDNEY (chronic kidney disease).
Lab Monitoring
- Renal function (eGFR) should be assessed before initiating treatment and periodically thereafter.
- Blood glucose levels should be monitored regularly.
- Electrolyte levels should be monitored, especially in patients at risk of dehydration.
Doctor Notes
- Educate patients on symptoms of genitourinary infections and ketoacidosis.
- Monitor renal function (eGFR) at baseline and periodically, especially in elderly and those with renal impairment.
- Advise patients to maintain adequate hydration to minimize risk of dehydration and hypotension.
- Caution when co-prescribing with diuretics, ACE inhibitors/ARBs, or insulin/sulfonylureas due to potential for additive effects.
Patient Guidelines
- Stay well-hydrated throughout the day.
- Monitor your blood glucose levels regularly as advised by your doctor.
- Report any symptoms of urinary tract infection (e.g., burning sensation during urination, frequent urination) or genital yeast infection to your doctor.
- Be aware of symptoms of ketoacidosis (e.g., nausea, vomiting, abdominal pain, fruity-smelling breath, difficulty breathing) and seek immediate medical attention if they occur.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If you miss a dose, 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 take a double dose to make up for a missed one.
Driving Precautions
Empalina may cause dizziness. If you experience dizziness, avoid driving or operating machinery. Exercise caution, especially when combined with other medications that can lower blood sugar.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity as advised by your healthcare provider.
- Ensure adequate fluid intake to prevent dehydration, especially in hot weather or during illness.
- Limit alcohol consumption, as it can affect blood sugar levels.
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