📋 Indications & Clinical Dosage
*Type 2 diabetes mellitus not controlled by metformin and/or a sulfonylurea with either empagliflozin or linagliptin:*
Adult 18-74 years: 10/5 mg once daily, increased to 25/5 mg once daily if necessary and if tolerated
Adult 75 years and over: Initiation not recommended. Concomitant insulin dose needs to be reduced.
⛔ Contraindications
Severe renal impairment, end-stage renal disease or dialysis, hypersensitivity to the drugs.
⚠️ Precautions & Warnings
Renal impairment, hepatic impairment, heart failure. If a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.
🔄 Drug Interactions
Diuretics, antihypertensive, UGT enzyme inducers, agents affecting renal functions, potent CYP3A4 and P-gp inducer
⚠️ Adverse Reactions / Side Effects
Pancreatitis, heart failure, hypotension, ketoacidosis, acute kidney injury, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum (fourniers gangrene), genital mycotic infections, hypersensitivity reactions severe and disabling arthralgia and bullous pemphigoid.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Advised to avoid
Lactation / Breastfeeding:
Advised to avoid
📚 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.