Empatab M ER 10/1000mg Tablet 1 Strip

✔️ Side Effects of Empatab M ER 10/1000mg Tablet

Empagliflozin-related (≥5% incidence):

• Urinary tract infections
• Female genital fungal infections

Metformin-related (>5% incidence):

• Diarrhea, nausea, vomiting
• Bloating, stomach discomfort, indigestion
• Weakness, headache

Other adverse effects:

• Very common: Hypoglycemia (when used with insulin or sulfonylureas), digestive issues
• Common: Genital infections (e.g., vaginal yeast infections, balanitis), increased thirst, altered taste, itching, rash, frequent urination, elevated blood lipids
• Uncommon: Dehydration, hives, painful urination, increased blood creatinine levels, decreased kidney function, elevated hematocrit
• Rare: Diabetic ketoacidosis

✔️ Dosage & Administration

The dosage should be tailored to individual patient needs, considering efficacy and tolerance. This medication should be taken twice daily with meals. To minimize gastrointestinal side effects from Metformin, dose escalation should be gradual.

Maximum daily doses:

• Metformin Hydrochloride: 2000 mg
• Empagliflozin: 25 mg

Starting dose recommendations:

• Patients previously taking Metformin should switch to a combination with 5 mg of Empagliflozin while maintaining a similar total daily Metformin dosage.
• Patients previously on Empagliflozin should switch to a combination that includes 500 mg of Metformin, ensuring the same total daily dose of Empagliflozin.
• Those already using both drugs separately should switch to an equivalent combination dose.
• If a patient has volume depletion and has not taken Empagliflozin before, this condition should be corrected before starting the medication.

Extended-release formulation:

• Should be taken once daily with meals.
• Gradually increase the dose to reduce gastrointestinal side effects from Metformin.
• Do not exceed the maximum recommended daily doses.

Renal Impairment:

• Kidney function should be evaluated before starting treatment.
• This medication is contraindicated in patients with an eGFR below 45 mL/min/1.73 m².

Pediatric Use:

• Safety and effectiveness in individuals under 18 years of age have not been established.

✔️ Drug Interactions

• Diuretics: Combined use may increase urine output and frequency, potentially causing dehydration.
• Insulin & Insulin Secretagogues: Co-administration raises the risk of hypoglycemia.
• Urine Glucose Tests: Patients on SGLT2 inhibitors should use alternative methods to monitor blood sugar levels.
• Drugs Reducing Metformin Clearance: Medicines like ranolazine, vandetanib, dolutegravir, and cimetidine may lead to Metformin accumulation.
• Carbonic Anhydrase Inhibitors: Increase the risk of lactic acidosis.
• Drugs Affecting Blood Sugar: Some diuretics, corticosteroids, estrogen-based therapies, phenytoin, and others may cause hyperglycemia or hypoglycemia. Close monitoring is necessary when these drugs are added or withdrawn.
• Alcohol: May amplify Metformin’s effects on lactate metabolism, increasing the risk of lactic acidosis. Excessive alcohol consumption should be avoided.

✔️ Contraindications

• Allergic reaction to Empagliflozin or Metformin
• Acute metabolic acidosis (including lactic acidosis or diabetic ketoacidosis)
• Diabetic pre-coma
• Severe kidney failure (GFR <30 ml/min)
• Acute conditions that may impair kidney function (e.g., dehydration, severe infections, shock)
• Diseases causing oxygen deficiency in tissues (e.g., decompensated heart failure, respiratory failure, recent heart attack, or shock)
• Liver disease, alcoholism, or acute alcohol intoxication

✔️ Pregnancy & Breastfeeding

• Women should be advised about potential risks to the fetus, particularly during the second and third trimesters.
• The medication is not recommended while breastfeeding.

✔️ Overdose of Empatab M ER 10/1000mg Tablet 1 Strip

• Empagliflozin: Clinical studies have shown that doses up to 800 mg (32 times the highest recommended dose) did not cause toxicity.
• Metformin: Extremely high doses (up to 85 g) have not caused hypoglycemia but have led to lactic acidosis.
• Emergency Treatment: If lactic acidosis occurs, immediate hospitalization is required. Hemodialysis is the most effective method for removing excess Metformin and lactate from the bloodstream. The ability of hemodialysis to remove Empagliflozin has not been studied.

✔️ Precautions & Warnings

• Lactic Acidosis: Metformin use has been linked to rare but serious lactic acidosis cases. If suspected, the medication should be discontinued, and urgent medical care should be sought.
• Low Blood Pressure: Patients with renal impairment, elderly individuals, those with low blood pressure, or those taking diuretics should have their volume status corrected before starting treatment. Blood pressure should be closely monitored.
• Ketoacidosis: Patients presenting with symptoms of metabolic acidosis should be evaluated for ketoacidosis. If diagnosed, treatment should be stopped immediately.
• Kidney Function: If kidney injury occurs, the medication should be discontinued and appropriate treatment initiated.
• Infections: SGLT2 inhibitors can increase the risk of urinary tract infections, including serious conditions like pyelonephritis and Fournier’s gangrene. Any signs of infection should be addressed promptly.
• Hypoglycemia: If combined with insulin or insulin secretagogues, their dosage may need to be reduced to prevent hypoglycemia.
• Vitamin B12 Deficiency: Long-term Metformin use may lead to vitamin B12 deficiency. Regular blood monitoring is advised.
• Increased LDL Cholesterol: Cholesterol levels should be monitored and treated if necessary.
• Cardiovascular Outcomes: There is no definitive evidence that this medication reduces the risk of cardiovascular diseases.

✔️ Storage Instructions

• Store below 30°C in a dry place, away from direct light and moisture.
• Keep out of reach of children.