Zetakardoval is a fixed-dose combination of two antihypertensive agents: amlodipine (a calcium channel blocker) and valsartan (an angiotensin II receptor antagonist). It is used in patients whose blood pressure is not adequately controlled by either agent alone.
Indications for Use:
Treatment of essential hypertension in adult patients not adequately controlled with amlodipine or valsartan monotherapy.
Dosage and Method of Administration:
Recommended dose: one tablet daily (5/160 mg, 10/160 mg, 5/320 mg or 10/320 mg).
Can be taken with or without food.
Patients switching from monotherapy can be directly transitioned to the fixed-dose combination if clinically appropriate.
Use with caution in elderly patients and those with hepatic or renal impairment. Maximum recommended dose in hepatic impairment: 5/80 mg.
Contraindications:
Hypersensitivity to active substances or excipients
Severe hepatic impairment, biliary cirrhosis, cholestasis
Severe renal impairment (GFR < 30 ml/min/1.73 m²)
Pregnancy
Concomitant use with aliskiren in diabetic or renally impaired patients
Precautions:
Hypotension may occur in volume-depleted patients
Monitor renal function and electrolytes in renal impairment
Caution in patients with renal artery stenosis, aortic/mitral stenosis, HOCM
Risk of hyperkalaemia if used with potassium-sparing agents
Discontinue in case of angioedema
Avoid dual blockade of RAAS
Caution in hepatic impairment
Use is not recommended in children and adolescents (<18 years)
No data on safety post-kidney transplantation
Use with caution in drivers (possible dizziness, fatigue)
