📋 Indications & Clinical Dosage
*Therapyfor type 2 Diabetes mellitus:*
Adults: 250 mg/1.25 mg once daily. Patients with fasting glucose > 200 mg/dL; may start with 250 mg/1.25 mg twice daily. Dosage may be increased in increments of 250 mg/1.25 mg at intervals of not less than 2 wk; max daily dose 2000 mg/10 mg.
*Type 2 Diabetes previously treated with a sulphonylureas or metformin alone:*
Initial: 500 mg/2.5 mg or 500 mg/5 mg twice daily, can be increased in increments. Max daily dose 2000 mg/20 mg.
Children: Not recommended.
⛔ Contraindications
Renal dysfunction, congestive heart failure, acute diabetic ketoacidosis, metabolic acidosis, diabetic coma,
Suspend therapy during surgery & clinical investigations using IV-iodinated contrast media.
⚠️ Precautions & Warnings
Renal insufficiency, hepatic disease, concomitant medications that may affect renal function or result in significant haemodynamic change or may interfere with the disposition of metformin. Monitor haematologic parameters annually. Decreases vit 812 absorption, serum vit B12 measurements at 2 to 3 years interval is required.
🔄 Drug Interactions
Iodinated contrast media, alcohol, Thiazide & other diuretics, corti-costeroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers & INH may produce hyperglycaemia & lead to loss of glycaemic control. The hypoglycaemic action of sulfonylureas may be potentiated by NSAIDs &other highly protein-bound drugs, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOls, betablockers, ciprofloxacin, oral miconazole, furosemide, nifedipine & cationic drugs being eliminated by renal tubular secretion.
⚠️ Adverse Reactions / Side Effects
Nausea, vomiting, diarrhoea, abdominal pain, loss of appetite, crises of hepatic porphyria & porphyria cutanea, elevations of se-rum urea &creatinine conc. Transie,nt visual disturbances, Leukopenia, thrombocytopenia, pruritus urticaria, maculopapular rash. Rare: Agranulocytosis, haemolyticanaemia, bone marrow aplasia & pancytopenia, lactic acidosis, liver function test abnor-mality or hepatitis requiring withdrawals of treatment, cutaneous or visceral allergic angiitis, erythema multiforme, exfoliative dermatitis, photo-sensitization, urticaria evolving to shock & cross-sensitivity to sulphonamides.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Risk cannot be ruled out.
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.