Empatab M ER 5/1000mg Tablet 1 Strip

✔️ Dosage & Administration of Empatab M ER 5/1000

Dosage is individualized based on the patient’s response and tolerance. The medication should be taken twice daily with meals, with dose adjustments done gradually to minimize gastrointestinal side effects.

Maximum daily dosage:

• Metformin Hydrochloride: 2000 mg
• Empagliflozin: 25 mg

Recommended starting doses:

• Patients currently on Metformin: Switch to this combination containing Empagliflozin 5 mg with an equivalent daily dose of Metformin.
• Patients currently on Empagliflozin: Switch to this combination containing Metformin Hydrochloride 500 mg with an equivalent daily dose of Empagliflozin.
• Patients already taking both drugs separately: Transition to this combination while maintaining the same total daily dose.
• Patients with volume depletion (such as dehydration) should correct this condition before starting the medication.

Extended-release formulation:

• Taken once daily with meals to minimize gastrointestinal effects.
• Dose should be adjusted based on effectiveness and tolerability, without exceeding the maximum recommended daily dose.

Renal Impairment:

• Not recommended for patients with an eGFR below 45 mL/min/1.73 m² due to reduced kidney function.

Pediatric Use:

• Not recommended for individuals under 18 years due to a lack of safety and efficacy data.

✔️ Common Side Effects of Empatab M ER 5/1000

Empagliflozin-related:

• Urinary tract infections
• Genital yeast infections (in women)

Metformin-related:

• Diarrhea, nausea, vomiting, bloating, indigestion
• Fatigue, headache

✔️ Adverse Reactions: Empatab M ER 5/1000

Very Common:

• Hypoglycemia (if taken with insulin or sulfonylureas)
• Gastrointestinal discomfort

Common:

• Genital fungal infections (vaginal yeast infections, balanitis in men)
• Frequent urination, increased thirst, skin itching, rash
• Increased cholesterol levels

Uncommon:

• Dehydration (volume depletion), hives, pain during urination
• Increased creatinine levels (kidney function impairment)

Rare:

• Diabetic ketoacidosis (life-threatening)

✔️ Overdose Effects

• Empagliflozin Overdose: High doses (up to 800 mg) have not shown severe toxicity.
• Metformin Overdose: Extremely high doses may cause lactic acidosis, which requires immediate hospital treatment.
• Hemodialysis: Used for removing excess Metformin and lactate. The effect of dialysis on Empagliflozin clearance is unknown.

✔️ Drug Interactions

• Diuretics: Increased urination, potential risk of dehydration.
• Insulin or Insulin Secretagogues: Higher risk of hypoglycemia when used together.
• Urine Glucose Tests: Not reliable for monitoring glycemic control while on SGLT2 inhibitors.
• Drugs that Reduce Metformin Clearance: (e.g., ranolazine, cimetidine) may increase Metformin accumulation and the risk of lactic acidosis.
• Carbonic Anhydrase Inhibitors: May increase the risk of lactic acidosis.
• Drugs Affecting Blood Sugar Levels: (e.g., diuretics, corticosteroids, thyroid hormones, estrogen, oral contraceptives, phenytoin) may cause hyperglycemia or hypoglycemia when discontinued.
• Alcohol: Can enhance Metformin’s effects on lactate metabolism, increasing the risk of lactic acidosis.

✔️ Contraindications:

• Allergy to Empagliflozin or Metformin
• Metabolic acidosis (including lactic acidosis and diabetic ketoacidosis)
• Diabetic pre-coma
• Severe kidney disease (eGFR <30 ml/min)
• Acute illnesses affecting kidney function (e.g., dehydration, severe infections, shock)
• Conditions causing tissue hypoxia (e.g., heart failure, respiratory failure, recent heart attack, shock)
• Liver disease, alcohol intoxication, or alcoholism

✔️ Pregnancy & Breastfeeding

• The drug is not recommended during pregnancy, especially in the second and third trimesters due to potential risks to the fetus.
• Breastfeeding is not advised as the effects on infants are unknown.

✔️ Precautions & Warning

• Lactic Acidosis: Rare but life-threatening. If suspected, stop medication immediately and seek medical help.
• Hypotension (Low Blood Pressure): Patients with dehydration, kidney disease, or elderly patients should be monitored closely.
• Diabetic Ketoacidosis (DKA): Can occur even with normal blood sugar levels. Monitor for symptoms such as nausea, vomiting, abdominal pain, fatigue, or difficulty breathing.
• Kidney Impairment: Temporary discontinuation is advised during severe illness, dehydration, or surgery.
• Urinary Tract & Genital Infections: Increased risk of serious infections like pyelonephritis and Fournier’s gangrene (a rare but life-threatening genital infection). Seek medical attention if fever, pain, or swelling occur.
• Hypoglycemia Risk: If taken with insulin or other diabetes medications, a dose adjustment may be required to prevent dangerously low blood sugar.
• Vitamin B12 Deficiency: Long-term use may reduce vitamin B12 levels, requiring periodic blood tests.
• Increased LDL Cholesterol: Requires monitoring and treatment as necessary.

✔️ Storage Instructions

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