Empazin-M
Generic Name
Empagliflozin + Metformin Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empazin m 5 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Empazin-M is an oral antidiabetic medication combining empagliflozin, an SGLT2 inhibitor, and metformin, a biguanide, used to improve glycemic control in adults with type 2 diabetes mellitus. It helps to lower blood glucose by increasing glucose excretion in the urine and by reducing hepatic glucose production and improving insulin sensitivity.
Uses & Indications
Dosage
Adults
Initial dose typically Empagliflozin 5 mg / Metformin 500 mg once or twice daily, adjusted based on efficacy and tolerability, up to a maximum of Empagliflozin 25 mg / Metformin 2000 mg daily. To be taken with meals.
Elderly
Caution advised, renal function should be monitored. Lower starting doses might be considered.
Renal_impairment
Not recommended if eGFR is below 30 mL/min/1.73m². Dosage adjustments required for eGFR between 30 and 60 mL/min/1.73m². Metformin is contraindicated below certain eGFR thresholds.
How to Take
Orally, with meals, to reduce gastrointestinal side effects associated with metformin.
Mechanism of Action
Empagliflozin: Selectively inhibits SGLT2 in the renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin: Decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Empagliflozin: Glycosuric effect seen within hours. Metformin: Glycemic effects usually seen within days.
Excretion
Empagliflozin: Primarily renal (approx. 50% unchanged), some fecal. Metformin: Primarily renal (approx. 90% unchanged).
Half life
Empagliflozin: Approx. 12.4 hours. Metformin: Approx. 4-9 hours.
Absorption
Empagliflozin: Rapid absorption, Tmax 1.5 hours. Metformin: Slow and incomplete absorption, Tmax 2-3 hours.
Metabolism
Empagliflozin: Primarily glucuronidation. Metformin: Not metabolized; excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR <30 mL/min/1.73m²) or end-stage renal disease, or dialysis.
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute or chronic metabolic acidosis (e.g., lactic acidosis).
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension (with empagliflozin).
ACE Inhibitors/ARBs
May increase risk of renal dysfunction.
Insulin/Sulfonylureas
Increased risk of hypoglycemia (dose adjustment may be needed).
Cationic drugs (e.g., Cimetidine, Ranitidine)
May increase metformin levels.
Storage
Store below 30°C, in a dry place, away from light. Keep out of reach of children.
Overdose
Empagliflozin: Symptoms primarily relate to volume depletion. Treatment is symptomatic. Metformin: Lactic acidosis is the most serious consequence. Treatment involves supportive measures, hemodialysis may be effective.
Pregnancy & Lactation
Pregnancy: Category B (Metformin), Category C (Empagliflozin). Not recommended during the second and third trimesters due to potential renal effects on the fetus. Lactation: Not recommended, as both drugs are excreted in milk.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR <30 mL/min/1.73m²) or end-stage renal disease, or dialysis.
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute or chronic metabolic acidosis (e.g., lactic acidosis).
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension (with empagliflozin).
ACE Inhibitors/ARBs
May increase risk of renal dysfunction.
Insulin/Sulfonylureas
Increased risk of hypoglycemia (dose adjustment may be needed).
Cationic drugs (e.g., Cimetidine, Ranitidine)
May increase metformin levels.
Storage
Store below 30°C, in a dry place, away from light. Keep out of reach of children.
Overdose
Empagliflozin: Symptoms primarily relate to volume depletion. Treatment is symptomatic. Metformin: Lactic acidosis is the most serious consequence. Treatment involves supportive measures, hemodialysis may be effective.
Pregnancy & Lactation
Pregnancy: Category B (Metformin), Category C (Empagliflozin). Not recommended during the second and third trimesters due to potential renal effects on the fetus. Lactation: Not recommended, as both drugs are excreted in milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
DGDA Approved
Patent Status
Patent Expired for active ingredients, product patent may vary
Clinical Trials
Ongoing and completed trials for glycemic control, cardiovascular outcomes, and renal outcomes in type 2 diabetes and heart failure, demonstrating significant benefits.
Lab Monitoring
- Renal function (eGFR)
- HbA1c
- Blood glucose
- Electrolytes
- Vitamin B12 levels (long-term metformin use)
Doctor Notes
- Important to counsel patients on hydration and symptoms of ketoacidosis/UTIs. Monitor renal function periodically, especially in elderly patients. Advise on dietary adherence and potential for B12 deficiency with long-term metformin use.
Patient Guidelines
- Take exactly as prescribed, with meals.
- Maintain adequate hydration by drinking enough fluids.
- Be aware of symptoms of hypoglycemia, urinary tract infections, and ketoacidosis and report them to your doctor.
- Report any unusual symptoms or signs of infection immediately.
Missed Dose Advice
If a dose is missed, take it as soon as remembered unless it's almost time for the next dose. Do not double the dose.
Driving Precautions
May cause dizziness or hypoglycemia, which can affect the ability to drive or operate machinery. Patients should be aware of how they react to the medication before driving.
Lifestyle Advice
- Adhere to diet and exercise recommendations for diabetes management.
- Avoid excessive alcohol consumption due to increased risk of lactic acidosis.
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