Empatab M

Indications

Empatab M is prescribed for the management of type 2 diabetes mellitus in adults, as an adjunct to a balanced diet and exercise program. It is specifically indicated for:

• Patients inadequately controlled on their maximum dose of Metformin alone.
• Combination therapy with other antidiabetic medications for individuals insufficiently controlled with Metformin and other drugs.
• Patients currently using Empagliflozin and Metformin as separate tablets, who may benefit from a combined formulation.

Note: Always consult a registered healthcare provider before using this medication.

Pharmacology

Empagliflozin is a potent Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitor. By blocking the SGLT2 protein, it prevents the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion. This helps lower blood glucose levels in patients with type 2 diabetes.

Metformin is a biguanide antihyperglycemic agent that improves insulin sensitivity, reduces glucose production in the liver, and decreases glucose absorption from the intestines. It helps control both fasting and postprandial blood glucose levels without causing hypoglycemia.

Dosage & Administration

The dosage of Empatab M should be tailored to each individual based on their response and tolerance to treatment:

• For patients already on Metformin, switch to this combination tablet with Empagliflozin 5 mg and the same total daily dose of Metformin.
• For those on Empagliflozin, start with Metformin 500 mg and maintain the same total daily dose of Empagliflozin.
• For individuals currently using Empagliflozin and Metformin separately, combine the total daily doses into one tablet.

Renal Impairment: Before initiating treatment, assess renal function. Empatab M is contraindicated in patients with an eGFR below 45 mL/min/1.73 m².

Pediatric Use: Safety and efficacy in patients under 18 have not been established.

Interactions

• Diuretics: May increase urine volume and the risk of volume depletion.
• Insulin/Insulin Secretagogues: Risk of hypoglycemia may be increased when used with insulin or insulin secretagogues.
• Drugs Affecting Metformin Clearance: Medications such as ranolazine or cimetidine can reduce Metformin clearance, potentially increasing its levels in the bloodstream.
• Alcohol: Excessive alcohol intake can increase the risk of lactic acidosis when using Metformin.

Contraindications

• Hypersensitivity to Empagliflozin or Metformin.
• Acute metabolic acidosis (including lactic acidosis and diabetic ketoacidosis).
• Severe renal impairment (eGFR < 30 mL/min).
• Acute conditions such as dehydration, severe infections, or shock that can worsen kidney function.

Side Effects

Common side effects may include:

• Empagliflozin: Urinary tract infections, genital mycotic infections (vaginal or balanitis), increased urination, thirst, and taste disturbances.
• Metformin: Gastrointestinal symptoms like diarrhea, nausea, vomiting, abdominal discomfort, and flatulence.

Serious side effects may include:

• Lactic acidosis, a rare but severe condition.
• Ketoacidosis or worsening kidney function.

If any serious reactions occur, consult your healthcare provider immediately.

Pregnancy & Lactation

• Pregnancy: Empatab M is not recommended during pregnancy, especially in the second and third trimesters.
• Lactation: It is advised not to breastfeed while using this medication, as both Empagliflozin and Metformin can be passed through breast milk.

Precautions & Warnings

• Lactic Acidosis: Risk of lactic acidosis in patients with certain conditions. Immediate medical attention is required if symptoms occur.
• Hypotension: Correct volume status before starting treatment, especially in elderly patients or those with kidney impairment.
• Ketoacidosis: Monitor for signs of metabolic acidosis. Discontinue treatment if symptoms are suspected.
• Genital Infections: Increased risk of urinary tract infections and genital mycotic infections with SGLT2 inhibitors.

Overdose Effects

In clinical trials, Empatab M has shown a high safety margin. Overdose may lead to mild gastrointestinal symptoms or lactic acidosis. In case of overdose, haemodialysis is the most effective treatment.

Therapeutic Class

Combination oral antihyperglycemic drugs for managing type 2 diabetes mellitus.

Storage Conditions

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