Emaglin-M
Generic Name
Empagliflozin and Metformin Hydrochloride
Manufacturer
XYZ Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| emaglin m 5 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Emaglin-M 5 mg Tablet is a fixed-dose combination medication containing Empagliflozin and Metformin Hydrochloride. It is used to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin helps the kidneys remove glucose from the bloodstream, while Metformin reduces glucose production in the liver and improves insulin sensitivity.
Uses & Indications
Dosage
Adults
The dosage is individualized based on the patient's current regimen, efficacy, and tolerability, not exceeding the maximum recommended daily doses of empagliflozin (25 mg) and metformin (2000 mg). A common starting dose might be Empagliflozin 5 mg/Metformin 500 mg orally twice daily with meals.
Elderly
No specific dose adjustment is required based on age alone, but renal function should be monitored frequently, as elderly patients are more likely to have decreased renal function.
Renal_impairment
Dose adjustment is required based on estimated glomerular filtration rate (eGFR). Not recommended for patients with an eGFR less than 30 mL/min/1.73 m². Metformin is contraindicated if eGFR is below 30 mL/min/1.73 m².
How to Take
Take Emaglin-M orally, usually twice daily with meals to reduce gastrointestinal side effects associated with metformin. Swallow the tablet whole with water.
Mechanism of Action
Emaglin-M combines the complementary mechanisms of action of empagliflozin and metformin to improve glycemic control. Empagliflozin, a SGLT2 inhibitor, reduces renal reabsorption of glucose, leading to increased urinary glucose excretion. Metformin, a biguanide, primarily decreases hepatic glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Empagliflozin's glucose-lowering effect typically begins within 30 minutes to an hour. Metformin's full glucose-lowering effect may take several days.
Excretion
Approximately half of empagliflozin is renally excreted, and the other half is eliminated via feces. Metformin is primarily eliminated unchanged by the kidneys.
Half life
The terminal elimination half-life of empagliflozin is approximately 12.4 hours. The plasma elimination half-life of metformin is approximately 6.2 hours, and blood half-life is approximately 17.6 hours.
Absorption
Empagliflozin is rapidly absorbed with peak plasma concentrations (Cmax) reached approximately 1.5 hours post-oral administration. Bioavailability is approximately 78%. Metformin is slowly and incompletely absorbed, with an absolute bioavailability of 50-60%. Cmax for metformin occurs 2-3 hours after a dose.
Metabolism
Empagliflozin is primarily metabolized by glucuronidation. Metformin is not metabolized in humans; it is excreted unchanged.
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 patients on dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Conditions that increase the risk of lactic acidosis, such as acute myocardial infarction, acute congestive heart failure, severe infection (sepsis), or dehydration.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin, avoid excessive alcohol intake.
Lithium
SGLT2 inhibitors may decrease serum lithium concentrations.
Loop Diuretics
May increase the risk of dehydration and hypotension, especially with empagliflozin.
Insulin or Insulin Secretagogues
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Cationic drugs (e.g., Cimetidine, Trimethoprim, Ranolazine, Dolutegravir)
May increase metformin levels by competing for renal tubular transport.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin may lead to symptoms of dehydration (e.g., thirst, dizziness) and severe hypoglycemia (if co-administered with other antidiabetics). Metformin overdose can lead to severe lactic acidosis. Management includes supportive measures, correcting dehydration, and hemodialysis in severe cases of metformin overdose to rapidly remove metformin.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development in the fetus (empagliflozin) and limited data on metformin. Lactation: Not recommended during breastfeeding as both empagliflozin and metformin are excreted into breast milk.
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 patients on dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Conditions that increase the risk of lactic acidosis, such as acute myocardial infarction, acute congestive heart failure, severe infection (sepsis), or dehydration.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin, avoid excessive alcohol intake.
Lithium
SGLT2 inhibitors may decrease serum lithium concentrations.
Loop Diuretics
May increase the risk of dehydration and hypotension, especially with empagliflozin.
Insulin or Insulin Secretagogues
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Cationic drugs (e.g., Cimetidine, Trimethoprim, Ranolazine, Dolutegravir)
May increase metformin levels by competing for renal tubular transport.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose of empagliflozin may lead to symptoms of dehydration (e.g., thirst, dizziness) and severe hypoglycemia (if co-administered with other antidiabetics). Metformin overdose can lead to severe lactic acidosis. Management includes supportive measures, correcting dehydration, and hemodialysis in severe cases of metformin overdose to rapidly remove metformin.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development in the fetus (empagliflozin) and limited data on metformin. Lactation: Not recommended during breastfeeding as both empagliflozin and metformin are excreted into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the manufacturing date, consult the product packaging for exact details.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, EMA, DGDA)
Patent Status
Patented (Empagliflozin component and combination formulation)
WHO Essential Medicine
YesClinical Trials
Empagliflozin (a component of Emaglin-M) has been extensively studied in major clinical trials like EMPA-REG OUTCOME, EMPEROR-Reduced, and EMPEROR-Preserved, demonstrating its efficacy in glycemic control and significant cardiovascular and renal benefits. Metformin has a long history of clinical use and efficacy.
Lab Monitoring
- Assess renal function (eGFR) before initiation and at least annually thereafter.
- Monitor blood glucose levels (fasting plasma glucose, postprandial glucose) and HbA1c periodically.
- Monitor vitamin B12 levels periodically, especially with prolonged metformin therapy.
- Liver function tests and lipid profile may be monitored as clinically indicated.
Doctor Notes
- Before initiating Emaglin-M, assess patient's renal function (eGFR). Reassess eGFR at least annually.
- Counsel patients on the importance of hydration to minimize volume depletion and UTI risk.
- Educate patients on the signs and symptoms of lactic acidosis, ketoacidosis, and Fournier's gangrene and instruct them to seek immediate medical attention if these occur.
- Consider dose adjustment of concomitant insulin or insulin secretagogues upon initiation to reduce hypoglycemia risk.
Patient Guidelines
- Take Emaglin-M exactly as prescribed by your doctor, usually with meals.
- Maintain adequate hydration by drinking plenty of fluids to reduce the risk of dehydration.
- Monitor your blood glucose levels regularly as advised by your healthcare provider.
- Be aware of the symptoms of urinary tract infections, genital yeast infections, ketoacidosis, and lactic acidosis, and report them immediately to your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for a missed dose. Consult your doctor if you frequently miss doses.
Driving Precautions
Emaglin-M generally does not directly impair the ability to drive or operate machinery. However, if symptoms of hypoglycemia (e.g., dizziness, blurred vision, weakness) occur, especially when used with insulin or sulfonylureas, avoid driving or operating machinery.
Lifestyle Advice
- Follow a healthy diet plan and engage in regular physical activity as part of your diabetes management.
- Limit or avoid excessive alcohol intake, as it can increase the risk of lactic acidosis associated with metformin.
- Maintain good personal hygiene to reduce the risk of genital infections.
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