📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus as monotherapy or in combination with metformin or pioglitazone (dual therapy) or in combination with both metformin and a sulfonylurea (triple therapy) or in combination with insulin (with or without metformin) to achieve adequate glycaemic control:*
Adult: 50 mg twice daily
*Type 2 diabetes mellitus in combination with sulfonylurea (if metformin inappropriate):*
Adult: 50 mg daily, dose to be taken in the morning
Dose of concomitant sulfonylurea or insulin may need to be reduced.
Children: Not recommended.
⛔ Contraindications
Ketoacidosis, severe heart failure, severe hepatic impairment.
⚠️ Precautions & Warnings
Renal impairment, reduce dose to 50mg once daily if eGFR less than 50 ml/minute/1.73m2, elderly, monitor liver function before treatment and every 3 months for first year and periodically thereafter.
⚠️ Adverse Reactions / Side Effects
Peripheraloedema, lactic acidosis (discontinue), asthenia, dizziness, headache, tremor, arthralgia, constipation, hypoglycaemia, Rare: Hepatic dysfunction, upper respiratory tract infection, nasopharyngitis, exfoliativeskin reactions and pancreatitis (discontinue).
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Contraindicated or not recommended.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.