Evania M 5/500mg Tablet

✔️ Evania-M Tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise in the following situations:

1. Inadequate control on Metformin alone: For patients not sufficiently controlled on their maximally tolerated dose of Metformin.
2. Combination therapy: In combination with other antidiabetic medications in patients not controlled with Metformin and these medications.
3. Pre-existing combination therapy: For patients already on Empagliflozin and Metformin as separate tablets.

✔️ Side Effects

Empagliflozin:

• Common: Urinary tract infections, genital mycotic infections, thirst, increased urination.
• Rare: Diabetic ketoacidosis, Fournier’s gangrene.

Metformin:

• Very common: Gastrointestinal disturbances, hypoglycemia (with sulfonylureas or insulin).
• Rare: Lactic acidosis, vitamin B12 deficiency.

✔️ Dosage & Administration

• Individualized dosage: Based on patient response and tolerability.
• Administration: Take twice daily with meals. Gradual dose escalation is recommended to minimize gastrointestinal side effects.

Maximum daily doses:

• Metformin Hydrochloride: 2000 mg.
• Empagliflozin: 25 mg.

1. Switching from Metformin alone: Start with Empagliflozin 5 mg and a similar total daily dose of Metformin.
2. Switching from Empagliflozin alone: Start with Metformin Hydrochloride 500 mg and a similar total daily dose of Empagliflozin.
3. Current combination therapy: Use the same total daily doses of Empagliflozin and Metformin as in existing therapy.
4. Volume-depleted patients: Correct dehydration before initiating therapy.

• Renal impairment: Contraindicated in patients with an eGFR <45 mL/min/1.73 m².
• Pediatric patients: Not recommended for patients under 18 years.

✔️ Interaction

1. Diuretics: May increase volume depletion risks.
2. Insulin or insulin secretagogues: Increased risk of hypoglycemia.
3. Drugs reducing Metformin clearance (e.g., ranolazine, cimetidine): Increased risk of lactic acidosis.
4. Alcohol: Potentiates the effect of Metformin on lactate metabolism. Avoid excessive alcohol consumption.

✔️ Contraindications

• Hypersensitivity to Empagliflozin or Metformin.
• Acute metabolic acidosis (e.g., lactic acidosis, diabetic ketoacidosis).
• Severe renal failure (GFR <30 mL/min).
• Acute conditions affecting renal function (e.g., dehydration, severe infection, shock).
• Hepatic impairment or alcohol abuse.

✔️ Pregnancy & Lactation

• Pregnancy: Potential risks to the fetus during the second and third trimesters. Use only if benefits outweigh risks.
• Lactation: Not recommended as it is unclear if the components are excreted in breast milk.

✔️ Precautions & Warnings

1. Lactic acidosis: Rare but serious. Immediate discontinuation and hospital treatment are required if suspected.
2. Hypotension: Monitor for symptoms, especially in elderly or volume-depleted patients.
3. Ketoacidosis: Evaluate patients with metabolic acidosis symptoms promptly.
4. Renal function: Monitor regularly; discontinue if acute kidney injury occurs.
5. Infections: Increased risk of urinary and genital infections. Treat promptly if symptoms occur.
6. Vitamin B12 deficiency: Monitor annually.

✔️ Storage:

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