Emfogen-M XR
Generic Name
Empagliflozin and Metformin Hydrochloride Extended-Release Tablet
Manufacturer
Hypothetical Pharmaceutical Co. Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| emfogen m xr 25 mg tablet | ৳ 45.00 | ৳ 270.00 |
Description
Overview of the medicine
Emfogen-M XR 25 mg Tablet is a combination medication containing Empagliflozin and Metformin Hydrochloride extended-release. It is used to improve glycemic control in adults with type 2 diabetes mellitus when diet and exercise alone do not provide adequate control. Empagliflozin works by increasing glucose excretion in the urine, while Metformin decreases glucose production in the liver and improves insulin sensitivity.
Uses & Indications
Dosage
Adults
Recommended starting dose is based on current Metformin therapy and renal function. Typically, one tablet once daily in the morning with food. The dose should be individualized based on effectiveness and tolerability, not exceeding 25 mg empagliflozin and 2000 mg metformin daily.
Elderly
Close monitoring of renal function is recommended. Dose adjustment may be necessary based on renal function.
Renal_impairment
Initiation not recommended if eGFR is below 30 mL/min/1.73 m². Dose adjustment or discontinuation may be required based on eGFR levels. Avoid if eGFR < 30 mL/min/1.73 m².
How to Take
Take orally once daily with a meal, preferably in the morning. Swallow the tablet whole; do not crush, cut, or chew.
Mechanism of Action
Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. Metformin is a biguanide that reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Glucose lowering effect typically observed within hours of first dose.
Excretion
Empagliflozin: Approximately 50% renally, 50% fecally. Metformin: Primarily excreted unchanged via the kidneys.
Half life
Empagliflozin: Approximately 12.4 hours. Metformin: Approximately 4-9 hours (plasma), but longer in the gastrointestinal tract due to XR formulation.
Absorption
Empagliflozin: Rapidly absorbed, Cmax reached 1.5 hours. Metformin XR: Slowly and incompletely absorbed, Cmax 4-8 hours. Food may increase Empagliflozin exposure and affect Metformin XR absorption.
Metabolism
Empagliflozin: Primarily metabolized by glucuronidation. Metformin: Not metabolized in the liver; excreted unchanged.
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.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin.
Loop Diuretics
May increase the risk of dehydration and hypotension with empagliflozin.
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia, dose adjustment may be required.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis with metformin.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include lactic acidosis (metformin) or symptoms related to volume depletion and hypoglycemia (empagliflozin). Treatment is symptomatic and supportive. Hemodialysis can remove metformin.
Pregnancy & Lactation
Pregnancy: Not recommended during the second and third trimesters due to potential adverse effects on renal development. Lactation: Not recommended. Metformin is excreted into human milk, and it is unknown if empagliflozin is excreted. Weigh benefits against risks.
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.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin.
Loop Diuretics
May increase the risk of dehydration and hypotension with empagliflozin.
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia, dose adjustment may be required.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis with metformin.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include lactic acidosis (metformin) or symptoms related to volume depletion and hypoglycemia (empagliflozin). Treatment is symptomatic and supportive. Hemodialysis can remove metformin.
Pregnancy & Lactation
Pregnancy: Not recommended during the second and third trimesters due to potential adverse effects on renal development. Lactation: Not recommended. Metformin is excreted into human milk, and it is unknown if empagliflozin is excreted. Weigh benefits against risks.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture
Availability
Pharmacies, hospitals, and clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Under patent protection (for innovator molecule), generics may exist in some regions
Clinical Trials
Extensive clinical trials (e.g., EMPA-REG OUTCOME) have demonstrated the efficacy and safety of empagliflozin in reducing HbA1c, cardiovascular events, and renal outcomes in patients with type 2 diabetes. Metformin has been a cornerstone of T2DM treatment for decades with proven efficacy.
Lab Monitoring
- Renal function (eGFR) at baseline and periodically thereafter.
- HbA1c levels regularly to assess glycemic control.
- Vitamin B12 levels (for metformin long-term use).
- Electrolytes if lactic acidosis is suspected.
Doctor Notes
- Assess renal function before initiation and periodically thereafter.
- Educate patients on symptoms of dehydration, ketoacidosis, and lactic acidosis.
- Consider temporary discontinuation in cases of acute illness or dehydration.
- Monitor for signs of genital mycotic infections and UTIs.
Patient Guidelines
- Take as directed by your doctor, usually once daily with food.
- Do not crush, cut, or chew the extended-release tablet.
- Stay well-hydrated to reduce the risk of dehydration.
- Monitor blood glucose regularly and report any unusual symptoms.
- Be aware of symptoms of lactic acidosis (unusual muscle pain, trouble breathing, stomach pain, dizziness, irregular heart rate) and seek immediate medical attention if they occur.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
This medication may cause dizziness or blurred vision. If you experience these symptoms, avoid driving or operating machinery. Hypoglycemia can impair your ability to drive.
Lifestyle Advice
- Maintain a healthy diet and regular exercise routine as advised by your healthcare provider.
- Limit alcohol intake, as it can increase the risk of lactic acidosis.
- Stay hydrated, especially during illness or strenuous activity.
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