Empatab M ER 25/1000mg Tablet 1 Strip

✔️ Dosage & Administration of Empatab M ER 25/1000mg Tablet

Dosing should be tailored to individual needs based on effectiveness and tolerance.

• Frequency: Take this combination twice daily with meals. To minimize gastrointestinal side effects from Metformin, dose escalation should be gradual.
• Maximum Recommended Dose: Metformin Hydrochloride 2000 mg/day, Empagliflozin 25 mg/day.

✔️ Side Effects of Empatab M ER 25/1000mg Tablet

Common adverse effects (≥5% incidence):

• Empagliflozin-related: Urinary tract infections, genital mycotic infections.
• Metformin-related: Diarrhea, nausea, vomiting, bloating, abdominal discomfort, indigestion, weakness, and headache.

Additional adverse reactions:

• Very Common: Hypoglycemia (when combined with sulfonylureas or insulin), gastrointestinal disturbances.
• Common: Genital infections (e.g., vaginal yeast infections, balanitis), increased urination, thirst, altered taste, itching, rash, elevated serum lipids.
• Uncommon: Volume depletion, urticaria, pain or discomfort during urination, increased blood creatinine, reduced glomerular filtration rate, increased hematocrit.
• Rare: Diabetic ketoacidosis.

✔️ Starting Dose Recommendations:

• For patients on Metformin alone: Switch to a combination containing Empagliflozin 5 mg with a similar daily dose of Metformin.
• For patients on Empagliflozin alone: Switch to a combination containing Metformin 500 mg with a similar daily dose of Empagliflozin.
• For patients already on both separately: Switch to the combination tablet containing the same daily doses of each component.
• For volume-depleted patients not previously on Empagliflozin: Correct the condition before starting treatment.

✔️ Extended-Release Formulations:

• Take film-coated tablets twice daily with meals, and extended-release tablets once daily with meals.
• Dose should be gradually increased to minimize the gastrointestinal side effects of Metformin.

✔️ Special Populations:

• Patients with Renal Impairment: Before initiating treatment, assess kidney function. Contraindicated in patients with an eGFR below 45 mL/min/1.73 m².
• Pediatric Patients (<18 years): Safety and effectiveness have not been established.

✔️ Drug Interactions

• Diuretics: May increase urine output and frequency, potentially leading to dehydration.
• Insulin/Insulin Secretagogues: May elevate the risk of hypoglycemia.
• Urine Glucose Tests: SGLT2 inhibitors can cause false-positive urine glucose tests; alternative monitoring methods should be used.
• Drugs Reducing Metformin Clearance: Ranolazine, vandetanib, dolutegravir, and cimetidine may lead to Metformin accumulation.
• Carbonic Anhydrase Inhibitors: May elevate the risk of lactic acidosis.
• Drugs Affecting Glycemic Control: Diuretics, corticosteroids, phenothiazines, thyroid medications, estrogens, contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid may cause hyperglycemia. Patients should be monitored for glycemic fluctuations when starting or stopping these medications.
• Alcohol: Excessive alcohol intake can intensify Metformin’s effects on lactate metabolism, increasing the risk of lactic acidosis.

✔️ Do not use Empatab M ER in patients with:

• Hypersensitivity to Empagliflozin or Metformin.
• Acute metabolic acidosis (e.g., lactic acidosis, diabetic ketoacidosis).
• Diabetic pre-coma.
• Severe kidney disease (GFR <30 mL/min).
• Acute conditions affecting kidney function (e.g., dehydration, severe infections, shock).
• Conditions causing tissue hypoxia (e.g., decompensated heart failure, respiratory failure, recent myocardial infarction, shock).
• Hepatic impairment, acute alcohol intoxication, or chronic alcoholism.

✔️ Overdose Management

• Empagliflozin Overdose: Doses up to 800 mg in clinical trials showed no toxicity.
• Metformin Overdose: While doses up to 85 g have not led to severe hypoglycemia, lactic acidosis has occurred.
• Treatment: If lactic acidosis is suspected, immediate hospitalization is required. Hemodialysis is the most effective method for removing lactate and Metformin. The clearance of Empagliflozin via hemodialysis has not been studied.

✔️ Use in Pregnancy & Lactation

• Pregnancy: Potential risks to the fetus, particularly during the second and third trimesters. Use only if necessary.
• Breastfeeding: Not recommended due to insufficient safety data.

✔️ Warnings & Precautions

• Lactic Acidosis: If suspected, discontinue treatment immediately and initiate supportive care in a hospital.
• Hypotension: Monitor blood pressure, especially in patients with renal impairment, the elderly, those with low systolic blood pressure, or those on diuretics.
• Ketoacidosis: Assess for metabolic acidosis in symptomatic patients, regardless of blood glucose levels. Discontinue if suspected and treat accordingly.
• Acute Kidney Injury: Consider temporarily discontinuing during conditions of reduced oral intake or fluid loss. Discontinue promptly if kidney injury occurs.
• Urinary Tract Infections: Increased risk of infections such as urosepsis, pyelonephritis, Fournier’s gangrene, and genital mycotic infections. Monitor and treat as necessary.
• Hypoglycemia Risk: Consider reducing insulin or sulfonylurea dosage when starting Empatab M ER.
• Vitamin B12 Deficiency: Periodic monitoring of hematologic parameters is advised.
• Elevated LDL-C: Monitor lipid levels and manage as needed.
• Macrovascular Complications: No conclusive evidence of reduced cardiovascular risk with this combination.

✔️ Storage Conditions

• Store below 30°C, protected from light and moisture.
• Keep out of reach of children.