Emparol-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 |
|---|---|---|
| emparol m 5 mg tablet | ৳ 15.00 | ৳ 105.00 |
Description
Overview of the medicine
Emparol-M is a combination oral anti-diabetic medication containing Empagliflozin and Metformin Hydrochloride. It is used to improve glycemic control in adults with type 2 diabetes mellitus.
Uses & Indications
Dosage
Adults
Initial dose based on current metformin/empagliflozin regimen. Typically, one tablet twice daily. Maximum daily dose for Empagliflozin is 25 mg, and for Metformin is 2000 mg.
Elderly
Dose adjustment may be needed based on renal function. Close monitoring recommended.
Renal_impairment
Not recommended for severe renal impairment (eGFR <30 mL/min/1.73m²). Dose adjustment may be necessary for moderate impairment.
How to Take
Take orally, with meals to reduce gastrointestinal side effects of Metformin.
Mechanism of Action
Empagliflozin selectively inhibits sodium-glucose co-transporter 2 (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.
Pharmacokinetics
Onset
Not immediately, but glycemic control improves over days/weeks.
Excretion
Empagliflozin: primarily via urine (50%) and feces (50%). Metformin: primarily via urine (renal excretion).
Half life
Empagliflozin: ~12.4 hours; Metformin: ~6.5 hours.
Absorption
Empagliflozin is rapidly absorbed with peak plasma concentrations reached in 1.5 hours. Metformin's absolute bioavailability is 50-60%.
Metabolism
Empagliflozin is primarily metabolized via glucuronidation. Metformin is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin or metformin.
- Severe renal impairment (eGFR <30 mL/min/1.73m²).
- Metabolic acidosis, including diabetic ketoacidosis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension.
Insulin or insulin secretagogues
Increased risk of hypoglycemia.
Cationic drugs (e.g., cimetidine)
May increase metformin accumulation.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to lactic acidosis (metformin) or hypoglycemia (if combined with insulin/sulfonylurea). Management involves supportive measures, discontinuation of the drug, and hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters. Caution should be exercised if used during lactation; risks versus benefits should be assessed.
Side Effects
Contraindications
- Hypersensitivity to empagliflozin or metformin.
- Severe renal impairment (eGFR <30 mL/min/1.73m²).
- Metabolic acidosis, including diabetic ketoacidosis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Drug Interactions
Diuretics
Increased risk of dehydration and hypotension.
Insulin or insulin secretagogues
Increased risk of hypoglycemia.
Cationic drugs (e.g., cimetidine)
May increase metformin accumulation.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to lactic acidosis (metformin) or hypoglycemia (if combined with insulin/sulfonylurea). Management involves supportive measures, discontinuation of the drug, and hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters. Caution should be exercised if used during lactation; risks versus benefits should be assessed.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA (USA), DGDA (Bangladesh)
Patent Status
Patented (original molecules), various generic versions available in Bangladesh
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., EMPA-REG OUTCOME) have demonstrated the efficacy and cardiovascular benefits of empagliflozin, often in combination with metformin.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiation and annually thereafter.
- Blood glucose levels (HbA1c).
- Vitamin B12 levels (for long-term metformin use).
Doctor Notes
- Assess renal function prior to initiation and periodically thereafter.
- Educate patients on symptoms of lactic acidosis and diabetic ketoacidosis.
Patient Guidelines
- Take with food to minimize stomach upset.
- Stay hydrated, especially during illness.
- Inform your doctor about any signs of lactic acidosis (e.g., unusual muscle pain, difficulty breathing).
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 double the dose.
Driving Precautions
Generally no direct impact. However, if hypoglycemia occurs (especially if combined with other anti-diabetics), it may impair driving ability.
Lifestyle Advice
- Maintain a balanced diet and regular exercise.
- Monitor blood glucose regularly as advised by your doctor.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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