Empazin-L
Generic Name
Empagliflozin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
empazin l 10 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Empagliflozin is an oral antidiabetic drug used to treat type 2 diabetes mellitus. It belongs to a class of drugs called SGLT2 inhibitors, which help the kidneys remove glucose from the bloodstream. It also reduces the risk of cardiovascular death, hospitalization for heart failure, and progression of kidney disease.
Uses & Indications
Dosage
Adults
The recommended starting dose is 10 mg once daily, taken in the morning, with or without food. The dose may be increased to 25 mg once daily based on glycemic control and tolerability.
Elderly
No dose adjustment is required based on age alone. However, renal function should be assessed before initiating and periodically during treatment.
Renal_impairment
For type 2 diabetes with eGFR ≥30 mL/min/1.73m², no dose adjustment is needed. Not recommended if eGFR <30 mL/min/1.73m² for glycemic control. For heart failure and CKD, initiation can be considered down to eGFR 20 mL/min/1.73m².
How to Take
Administer orally once daily in the morning, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Empagliflozin selectively inhibits sodium-glucose co-transporter 2 (SGLT2) in the renal proximal tubules, responsible for the majority of glucose reabsorption. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, leading to increased urinary glucose excretion (glucosuria), thereby lowering blood glucose levels.
Pharmacokinetics
Onset
Glucose lowering effects observed within 30-60 minutes.
Excretion
Approximately 50% excreted unchanged in urine, and approximately 50% excreted via feces.
Half life
Mean terminal elimination half-life is approximately 12-19 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) reached approximately 1.5 hours post-dose. Absolute bioavailability is approximately 78%.
Metabolism
Primarily metabolized via glucuronidation by uridine 5'-diphospho-glucuronosyltransferases (UGT1A3, UGT1A8, UGT1A9, UGT2B7, UGT2B10).
Side Effects
Contraindications
- Hypersensitivity to empagliflozin or any excipients.
- Severe renal impairment (eGFR <30 mL/min/1.73m²) for glycemic control indications.
- Dialysis patients (limited data, generally not recommended).
Drug Interactions
Diuretics
Co-administration with diuretics may increase the risk of dehydration and hypotension.
ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)
Potential for increased 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 the event of an overdose, symptomatic and supportive treatment should be initiated. Empagliflozin is not expected to be dialyzable.
Pregnancy & Lactation
Pregnancy Category C. Not recommended for use during the second and third trimesters of pregnancy due to potential adverse effects on kidney development. Avoid during lactation as it is unknown if empagliflozin is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, refer to package for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved, DGDA Approved
Patent Status
Patented by original innovator (Boehringer Ingelheim/Lilly)
WHO Essential Medicine
YesClinical Trials
Empagliflozin has been evaluated in several large-scale clinical trials including EMPA-REG OUTCOME (cardiovascular outcomes in T2DM), EMPEROR-Reduced and EMPEROR-Preserved (heart failure outcomes), and EMPA-KIDNEY (chronic kidney disease outcomes), demonstrating its benefits in these conditions.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiation and periodically during treatment.
- Glycemic control (HbA1c, fasting blood glucose).
- Lipid profile (though less direct impact, good practice in diabetes).
Doctor Notes
- Educate patients on symptoms of DKA, especially for those on insulin, and advise temporary discontinuation during prolonged fasting or surgery.
- Monitor renal function before and during treatment, particularly in elderly patients or those with pre-existing renal impairment.
- Advise patients about maintaining adequate hydration to prevent volume depletion.
Patient Guidelines
- Take empagliflozin once daily in the morning, with or without food.
- Stay well-hydrated, especially in hot weather or during illness, to reduce the risk of dehydration.
- Be aware of symptoms of urinary tract infections (UTIs) and genital mycotic infections (e.g., burning, itching, discharge) and report them to your doctor.
- Seek immediate medical attention if you experience symptoms of diabetic ketoacidosis (e.g., nausea, vomiting, abdominal pain, excessive thirst, rapid breathing).
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Empagliflozin generally does not affect the ability to drive or operate machinery. However, if symptoms like dizziness or lightheadedness occur, especially due to dehydration or hypoglycemia (if taken with insulin/sulfonylurea), caution is advised.
Lifestyle Advice
- Maintain a balanced diet and engage in regular physical activity as part of your diabetes management plan.
- Ensure adequate fluid intake to help prevent dehydration and kidney-related issues.
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Global Brand Names
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