📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus not controlled by metformin alone or in combination with either a sulfonylurea or pioglitazone or insulin:*
Adult: Initially 1 tablet50mg/500 mg or 50 mg/1000 mg twice daily. Doses of sulfonylurea or insulin may need to be reduced. Max daily dose of sitagliptin 100 mg.
Children: Not recommended.
⛔ Contraindications
Renal or hepatic impairment, diabetic ketoacidosis or pre-coma, cardiac or respiratory failure, recent MI, acute alcohol intoxication, alcoholism.
⚠️ Precautions & Warnings
Assess risk factors for lactic acidosis. Monitor renal function at least annually. Discontinue for 48 hours before and after surgery and measure renal function before resuming therapy, Elderly.
🔄 Drug Interactions
Alcohol, cimetidine, iodinated contrast agents,
glucocorticoids, ACE inhibitors, potent CYP3A4 inhibitors, digoxin, insulin, sulfonylureas, diuretics, beta2-agonists.
⚠️ Adverse Reactions / Side Effects
Serious hyper sensitivity reactions including anaphylaxis and Stevens-Johnson syndrome (discontinue),nausea, lactic acidosis (discontinue), hypoglycaemia, constipation, headache, diarrhoea, vomiting.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
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.