Brand Name: Zetakardoval Tablet.
Composition:
Each Zetakardoval 160/10 mg tablet contains:
valsartan/ amlodipine besylate ........................................................ 160 / 10 mg
Each Zetakardoval 160/5 mg tablet contains:
valsartan/ amlodipine besylate ........................................................ 160 / 5 mg
Each Zetakardoval 320/ 5 mg tablet contains:
valsartan/ amlodipine besylate ........................................................ 320/ 5 mg
Each Zetakardoval 320/ 10 mg tablet contains:
valsartan/ amlodipine besylate ........................................................ 320/ 10 mg
Therapeutic Indications:
- Treatment of essential hypertension.
Dosage and Administration:
- The recommended dose is one tablet per day.
Contraindications:
- Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients
- Severe hepatic impairment, biliary cirrhosis or cholestasis.
- Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2)
- Second and third trimesters of pregnancy
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high-grade aortic stenosis).
- Hemodynamically unstable heart failure after acute myocardial infarction.
Warnings and precautions:
- Pregnancy
- Sodium- and/or volume-depleted patients
- Hyperkalaemia
- Renal artery stenosis
- Kidney transplantation
- Hepatic impairment
- Renal impairment
- Primary hyperaldosteronism
- Angioedema
- Heart failure/post-myocardial infarction
- Aortic and mitral valve stenosis
- Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Undesirable Effects:
- nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush
Pharmacological Properties:
Zetakardoval combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone
Packaging:
Zetakardoval 160/10 mg Tablet; Box containing 3 blisters of 10 tablets each.
Zetakardoval 160/ 5 mg Tablet; Box containing 3 blisters of 10 tablets each.
Zetakardoval 320/5 mg Tablet; Box containing 3 blisters of 10 tablets each.
Zetakardoval 320/10 mg Tablet; Box containing 3 blisters of 10 tablets each.
