📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus as monotherapy (if metformin inappropriate), or in combination with insulin or other antidiabetic drugs (if existing treatment fails to achieve adequate glycaemic control):*
Adult: 5 mg once daily; increased to 15 mg once daily if necessary and if tolerated, dose to be taken in the morning.
Dose of concomitant sulfonylurea or insulin may need to be reduced.
⛔ Contraindications
Diabetic ketoacidosis, severe heart failure, severe hepatic impairment.
⚠️ Precautions & Warnings
Heart failure, dehydration, elderly, history of hypotension, volume depletion; correct hypovolaemia before starting treatment; consider interrupting treatment if volume depletion occurs. Cardiac disorders, renal impairment, hepatic impairment, monitor liver function before
treatment and every 3 months for first year and periodically thereafter, elderly, pituitary/adrenal insufficiency.
⚠️ Adverse Reactions / Side Effects
Hypoglycaemia, hypovolaemia, increased risk of infection, polydipsia, thirst, urinary disorders, vulvovaginal pruritus. Rare: Diabetic ketoacidosis (discontinue), Fourniers gangrene (discontinue). lower limb amputations, phimosis
🤰 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.