Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Treatment of essential hypertension.
Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Treatment of adult patients with symptomatic heart failure when ACE-inhibitors are not tolerated or in beta-blocker intolerant patients as add-on therapy to ACE-inhibitors when mineralocorticoid receptor antagonists cannot be used (see sections 4.2, 4.4, 4.5 and 5.1).
The recommended starting dose of Troval is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Troval may also be administered with other antihypertensive agents. The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients (see sections 4.3, 4.4, 4.5 and 5.1).
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction. After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks. The starting dose is provided by the 40 mg divisible tablet.
The target maximum dose is 160 mg twice daily. In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient’s tolerability. If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dosage reduction.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics. The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
The recommended starting dose of Troval is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Valsartan may be administered with other heart failure therapies. However, the triple combination of an ACE-inhibitor, a beta blocker and valsartan or a potassium-sparing diuretic is not recommended (see sections 4.4 and 5.1). Evaluation of patients with heart failure should always include assessment of renal function.
No dose adjustment is required in elderly patients.
No dosage adjustment is required for patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Troval is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2). In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Troval is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Troval may be taken independently of a meal and should be administered with water.
Overdose with Troval may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms; stabilisation of the circulatory condition is of prime importance.
If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
Valsartan is unlikely to be removed by haemodialysis.
36 months.
Store below 30°C. Keep in the original package in order to protect from moisture.
For 40 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.
For 80 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.
For 160 mg strength: Blister packs, PVC/PE/PVdC/Aluminium or oPA/Aluminium/PVC-Aluminium of 10, 20, 28, 30, 50, 56, 60, 80, 90 tablets.
Not all pack sizes may be marketed.
No special requirements.
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