📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus inadequately controlled by metformin alone or by metformin in combination with either a sulfonylurea or insulin:*
Adult: 1 tablet 50mg/850 mg or 50 mg/1000 mg twice daily, adjusted according to patients current metformin dose.
Children: Not recommended.
⛔ Contraindications
Renal or hepatic impairment, ketoacidosis or pre-coma, dehydration, severe infection, shock, cardiac or respiratory failure, recent MI, acute alcohol intoxication, alcoholism, patients above 75 years of age. Discontinue for 48hours before and after surgery.
⚠️ 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. Discontinue if patient develops jaundice or other signs of liver dysfunction.
🔄 Drug Interactions
Alcohol, cimetidine, iodinated contrast agents, corticosteroids, beta 2-agonists, diuretics, ACE inhibitors.
⚠️ Adverse Reactions / Side Effects
GI upset, lactic acidosis (discontinue), angioedema, reduced Vit. B12 absorption, peripheral oedema, asthenia, dizziness, headache, tremor, arthralgia, constipation, hypoglycaemia, Rare: Hepatic dysfunction, upper respiratory tract infection, nasopharyngitis, exfoliative skin 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.