Emjard-M XR
Generic Name
Empagliflozin and Metformin Hydrochloride Extended-Release Tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| emjard m xr 5 mg tablet | ৳ 25.00 | ৳ 100.00 |
Description
Overview of the medicine
Emjard-M XR 5 mg tablet is a combination medication containing Empagliflozin and Metformin Hydrochloride (extended-release) used to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin works by increasing glucose excretion in the urine, while Metformin decreases glucose production by the liver and improves insulin sensitivity.
Uses & Indications
Dosage
Adults
Initial dose is individualized based on patient's current treatment and tolerance, usually starting with lower doses of both components once daily with a meal. Maximum recommended daily dose for empagliflozin is 25 mg and for metformin is 2000 mg.
Elderly
Careful dose titration, consider age-related renal function decline. Avoid in severe renal impairment.
Renal_impairment
Not recommended for patients with eGFR <30 mL/min/1.73 m². Dose adjustment may be required for eGFR between 30 and 45 mL/min/1.73 m².
How to Take
Take orally once daily with a meal to reduce gastrointestinal side effects associated with metformin. Swallow the tablet whole; do not crush, cut, or chew.
Mechanism of Action
Empagliflozin is a selective SGLT2 inhibitor that reduces renal glucose reabsorption, leading to increased urinary glucose excretion and reduced blood glucose levels. Metformin, a biguanide, primarily reduces hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis. It also improves insulin sensitivity in peripheral tissues and delays intestinal glucose absorption.
Pharmacokinetics
Onset
Within hours for blood glucose lowering.
Excretion
Empagliflozin: Approximately 50% renally excreted, 50% via feces. Metformin: Primarily excreted unchanged in urine.
Half life
Empagliflozin: Approximately 12.4 hours. Metformin XR: Approximately 7-17 hours (plasma elimination).
Absorption
Empagliflozin: Rapidly absorbed, Cmax reached within 1.5 hours. Metformin XR: Extended absorption, Cmax reached within 7 hours, bioavailability ~50-60%.
Metabolism
Empagliflozin: Primarily metabolized via glucuronidation by UGT1A8, UGT1A3, UGT1A9, UGT2B7, UGT2B4. Metformin: Not metabolized in the liver.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Diabetic ketoacidosis
- Hypersensitivity to empagliflozin or metformin
- Metabolic acidosis, including lactic acidosis
Drug Interactions
Alcohol
Increases risk of lactic acidosis (with metformin). Avoid excessive alcohol intake.
Diuretics
May increase risk of dehydration and hypotension, especially with empagliflozin. Monitor fluid status and blood pressure.
Iodinated Contrast Agents
Temporarily discontinue metformin at the time of or prior to an iodinated contrast imaging procedure in patients with eGFR between 30 and 60 mL/min/1.73 m².
Carbonic Anhydrase Inhibitors
May increase risk of lactic acidosis (with metformin).
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia when used with empagliflozin. Dose adjustment may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, seek immediate medical attention. Management is symptomatic and supportive. Hemodialysis can remove metformin.
Pregnancy & Lactation
Empagliflozin: Not recommended during the second and third trimesters due to potential adverse effects on renal development. Metformin: Limited data, generally considered safe but consult a doctor. Lactation: Not recommended as both drugs are excreted in milk.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Diabetic ketoacidosis
- Hypersensitivity to empagliflozin or metformin
- Metabolic acidosis, including lactic acidosis
Drug Interactions
Alcohol
Increases risk of lactic acidosis (with metformin). Avoid excessive alcohol intake.
Diuretics
May increase risk of dehydration and hypotension, especially with empagliflozin. Monitor fluid status and blood pressure.
Iodinated Contrast Agents
Temporarily discontinue metformin at the time of or prior to an iodinated contrast imaging procedure in patients with eGFR between 30 and 60 mL/min/1.73 m².
Carbonic Anhydrase Inhibitors
May increase risk of lactic acidosis (with metformin).
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia when used with empagliflozin. Dose adjustment may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, seek immediate medical attention. Management is symptomatic and supportive. Hemodialysis can remove metformin.
Pregnancy & Lactation
Empagliflozin: Not recommended during the second and third trimesters due to potential adverse effects on renal development. Metformin: Limited data, generally considered safe but consult a doctor. 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
FDA Approved, DGDA Approved (Bangladesh)
Patent Status
Patented (Empagliflozin component), Metformin is off-patent
Clinical Trials
Clinical trials such as EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved demonstrated cardiovascular and renal benefits of empagliflozin. Metformin's efficacy is well-established through numerous trials. Combination trials confirm efficacy and safety of co-administration.
Lab Monitoring
- Renal function (eGFR) prior to initiation and periodically thereafter
- Glycemic control (HbA1c, fasting plasma glucose)
- Vitamin B12 levels (long-term metformin use)
- Electrolytes (if dehydration suspected)
Doctor Notes
- Counsel patients on the symptoms of lactic acidosis and ketoacidosis.
- Monitor renal function before initiating and annually thereafter.
- Advise patients on adequate hydration and sick-day management.
- Consider vitamin B12 monitoring in patients on long-term metformin therapy.
Patient Guidelines
- Take this medicine regularly as prescribed by your doctor.
- Swallow the extended-release tablet whole; do not crush, cut, or chew.
- Monitor your blood sugar levels regularly.
- Maintain a healthy diet and exercise regimen.
- Stay well-hydrated to reduce the risk of dehydration, especially during illness or hot weather.
- Report any unusual symptoms like severe abdominal pain, difficulty breathing, or unusual muscle pain immediately.
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 continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or low blood sugar (hypoglycemia), especially if used with insulin or sulfonylureas. Exercise caution when driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Follow a balanced diet low in refined sugars and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Avoid excessive alcohol consumption.
- Quit smoking to improve overall cardiovascular health.
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