Emaglin-M
Generic Name
Empagliflozin + Metformin Hydrochloride
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| emaglin m 125 mg tablet | ৳ 28.00 | ৳ 280.00 |
Description
Overview of the medicine
Emaglin-M 12.5 mg/1000 mg Tablet is a combination medication used to treat type 2 diabetes mellitus in adults. It contains Empagliflozin, an SGLT2 inhibitor, and Metformin Hydrochloride, a biguanide, which work together to lower blood glucose levels.
Uses & Indications
Dosage
Adults
Individualized based on efficacy and tolerability, typically starting with Empagliflozin 5 mg/Metformin 500 mg once or twice daily, titrating up to a maximum of Empagliflozin 25 mg/Metformin 2000 mg daily. The 12.5 mg/1000 mg tablet is usually taken twice daily.
Elderly
Cautious dose titration; monitor renal function due to increased risk of renal impairment with age.
Renal_impairment
Not recommended for eGFR < 30 mL/min/1.73 m². Dose adjustment required for eGFR 30-60 mL/min/1.73 m².
How to Take
Take orally, with meals to reduce gastrointestinal side effects, typically twice daily.
Mechanism of Action
Empagliflozin inhibits SGLT2 in the kidneys, reducing glucose reabsorption and increasing glucose excretion in the urine. Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Within hours for blood glucose lowering.
Excretion
Empagliflozin is excreted via urine (approximately 50%) and feces (approximately 50%). Metformin is excreted unchanged via the kidneys.
Half life
Empagliflozin: ~13.1 hours; Metformin: ~6.2 hours (plasma elimination half-life).
Absorption
Empagliflozin is rapidly absorbed with peak plasma concentrations reached in 1.5 hours. Metformin has an absolute bioavailability of 50-60%, with peak plasma concentrations reached in 2.5 hours.
Metabolism
Empagliflozin is primarily metabolized by glucuronidation. Metformin is not metabolized.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin, Metformin, or any excipients.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Hepatic impairment.
Drug Interactions
Alcohol
Increases risk of lactic acidosis.
Cimetidine
May increase Metformin levels.
Loop Diuretics
May increase risk of dehydration and hypotension.
Insulin or Sulfonylureas
Increased risk of hypoglycemia.
Storage
Store below 30°C, in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of Empagliflozin can lead to symptoms of dehydration and electrolyte imbalance. Metformin overdose can lead to lactic acidosis. Treatment is symptomatic and supportive. Hemodialysis can remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy (Category B/C for Empagliflozin, B for Metformin). Metformin is excreted in breast milk; consult physician. Empagliflozin not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin, Metformin, or any excipients.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Hepatic impairment.
Drug Interactions
Alcohol
Increases risk of lactic acidosis.
Cimetidine
May increase Metformin levels.
Loop Diuretics
May increase risk of dehydration and hypotension.
Insulin or Sulfonylureas
Increased risk of hypoglycemia.
Storage
Store below 30°C, in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of Empagliflozin can lead to symptoms of dehydration and electrolyte imbalance. Metformin overdose can lead to lactic acidosis. Treatment is symptomatic and supportive. Hemodialysis can remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy (Category B/C for Empagliflozin, B for Metformin). Metformin is excreted in breast milk; consult physician. Empagliflozin not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent protected (Empagliflozin component), Metformin is off-patent
Clinical Trials
Extensive clinical trials (e.g., EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved, EMPA-KIDNEY) have demonstrated the efficacy and cardiovascular/renal benefits of Empagliflozin and safety of Metformin combinations.
Lab Monitoring
- Renal function (eGFR) periodically
- HbA1c regularly
- Blood glucose levels
- Vitamin B12 levels (long-term Metformin use)
Doctor Notes
- Emphasize patient education on hydration and signs of ketoacidosis/lactic acidosis.
- Monitor renal function before initiation and periodically thereafter.
- Consider discontinuing temporarily in cases of acute illness or surgery due to increased risk of renal impairment and lactic acidosis.
Patient Guidelines
- Follow diet and exercise recommendations.
- Monitor blood glucose regularly.
- Report any signs of dehydration, unusual fatigue, or severe stomach pain.
- Drink plenty of fluids to avoid dehydration.
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses at once.
Driving Precautions
No direct impact, but hypoglycemia (if co-administered with other antidiabetics) or symptoms like dizziness may affect ability to drive or operate machinery. Be cautious.
Lifestyle Advice
- Maintain a healthy diet low in sugar and refined carbohydrates.
- Engage in regular physical activity.
- Avoid excessive alcohol consumption.
- Quit smoking.
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