📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus alone or combined with metformin or a sulfonylurea, or with both, or with insulin:*
Adult: Initially 15-30 mg once daily, adjusted according to response to 45 mg once daily, in elderly patients, initiate with lowest possible dose and increase gradually; review treatment after 3-6 months and regularly thereafter for risk-benefits assessment. Dosage of concomitant sulfonylurea or insulin may need to be reduced.
Children: Not recommended.
⛔ Contraindications
History of heart failure, previous or
active bladder cancer, uninvestigated macroscopic haematuria, dialysis, diabetic ketoacidosis, pregnancy and lactation.
⚠️ Precautions & Warnings
Porphyrias, Monitor for fluid retention or other signs of cardiac failure (discontinue if deteriorates). Monitor for signs of hepatic dysfunction and check liver enzymes prior to therapy and every 2 months thereafter, elderly, risk of bone fracture and bladder cancer particularly in women and elderly.
🔄 Drug Interactions
Insulin (contraindicated), NSAIDs, gemfibrozil, rifampicin.
⚠️ Adverse Reactions / Side Effects
GI disturbances, anaemia, arthralgia, dizziness, haematuria, headache, hypoaesthesia, impotence, oedema,
vertigo, visual disturbances, weight gain, altered blood lipids, bladder cancer, fatigue, hypoglycaemia, insomnia, proteinuria, sweating. Rare: Liver dysfunction.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated or not recommended
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.