Empazin-M
Generic Name
empazin-m-125-mg-tablet
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| empazin m 125 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Empazin-M 12.5 mg/1000 mg tablet is a combination of Empagliflozin and Metformin Hydrochloride, used to improve glycemic control in adults with type 2 diabetes mellitus. It works by reducing blood glucose levels through different mechanisms.
Uses & Indications
Dosage
Adults
Initial dose is typically Empagliflozin 5 mg and Metformin 500 mg once or twice daily with meals, gradually titrated to a maximum of Empagliflozin 25 mg and Metformin 2000 mg daily based on individual needs. For this specific strength (12.5 mg/1000 mg), usually one tablet twice daily.
Elderly
No specific dose adjustment is generally required based on age alone, but renal function should be monitored.
Renal_impairment
Not recommended for patients with eGFR <30 mL/min/1.73 m². Dose adjustment may be needed for eGFR 30-60 mL/min/1.73 m² (e.g., maximum Metformin 1000 mg/day, Empagliflozin up to 10 mg/day).
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 urinary glucose excretion. 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 both components to start lowering glucose.
Excretion
Empagliflozin: Primarily renal (~50%) and fecal (~50%). Metformin: Primarily renal, excreted unchanged.
Half life
Empagliflozin: ~12.4 hours; Metformin: ~6.2 hours.
Absorption
Empagliflozin is rapidly absorbed with a peak plasma concentration (Tmax) of 1.5 hours. Metformin has an absolute oral bioavailability of 50-60%, with Tmax reached in 2.5 hours.
Metabolism
Empagliflozin is primarily metabolized by glucuronidation. Metformin is excreted unchanged in the urine; it is not metabolized in the liver.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- 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.
- History of lactic acidosis with metformin.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis (with Metformin).
Diuretics
May increase risk of dehydration and hypotension.
Contrast agents
Temporary discontinuation of Metformin before or at the time of iodinated contrast imaging procedures.
Insulin and insulin secretagogues
Increased risk of hypoglycemia (dose adjustment may be needed).
Cationic drugs (e.g., cimetidine, ranitidine)
May increase Metformin concentrations.
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 may lead to increased urinary glucose excretion and mild gastrointestinal symptoms. Metformin overdose can lead to lactic acidosis, which requires immediate medical attention. Treatment is supportive and symptomatic; hemodialysis can be effective for Metformin removal.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Avoid during breastfeeding; Metformin is excreted into breast milk.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin, metformin, or any component of the formulation.
- 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.
- History of lactic acidosis with metformin.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis (with Metformin).
Diuretics
May increase risk of dehydration and hypotension.
Contrast agents
Temporary discontinuation of Metformin before or at the time of iodinated contrast imaging procedures.
Insulin and insulin secretagogues
Increased risk of hypoglycemia (dose adjustment may be needed).
Cationic drugs (e.g., cimetidine, ranitidine)
May increase Metformin concentrations.
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 may lead to increased urinary glucose excretion and mild gastrointestinal symptoms. Metformin overdose can lead to lactic acidosis, which requires immediate medical attention. Treatment is supportive and symptomatic; hemodialysis can be effective for Metformin removal.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Avoid during breastfeeding; Metformin is excreted into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patent protected (for originator, generics available)
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of empagliflozin/metformin in type 2 diabetes, including trials showing cardiovascular benefits (e.g., EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved).
Lab Monitoring
- Renal function (eGFR) before initiation and periodically during treatment.
- Glycemic control (HbA1c, fasting plasma glucose).
- Vitamin B12 levels (for long-term Metformin use).
- Lipid profile (periodically).
Doctor Notes
- Emphasize patient education on hydration, symptoms of UTI/genital infections, and signs of lactic acidosis.
- Consider discontinuing metformin prior to iodinated contrast procedures and in patients undergoing surgical procedures associated with restricted food and fluid intake.
- Regularly assess renal function, especially in elderly patients.
Patient Guidelines
- Take this medicine regularly as directed by your doctor.
- Maintain a balanced diet and regular exercise routine.
- Monitor blood glucose levels regularly as advised.
- Report any signs of dehydration, unusual fatigue, or infections promptly.
- Avoid excessive alcohol consumption.
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 a double dose to make up for a forgotten dose.
Driving Precautions
This medicine may cause dizziness or hypoglycemia, which can affect your ability to drive or operate machinery, especially if used with insulin or sulfonylurea. Use caution.
Lifestyle Advice
- Adopt a healthy lifestyle including dietary modifications (e.g., low-carb diet) and regular physical activity.
- Stay well-hydrated, especially in hot weather or during illness.
- Regularly check feet for any cuts or sores, as diabetic neuropathy can reduce sensation.
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