Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Treatment of hypertension in children and adolescents 6 to 18 years of age.
Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to less than 18 years of age.
Treatment of clinically stable adult 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 Valsartan 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.
Valsartan may also be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients.
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 Valsartan 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, valsartan and a beta-blocker 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 dose adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2). Concomitant use of valsartan with aliskiren is contraindicated in patients with renal impairment (GFR <60 mL/min/1.73 m²) (see section 4.3).
Concomitant use of valsartan with aliskiren is contraindicated in patients with diabetes mellitus (see section 4.3).
Valsartan 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.
For children and adolescents who are unable to swallow tablets, the use of the valsartan oral solution is recommended. The systemic exposure and peak plasma concentration of valsartan is about 1.7-fold and 2.2-fold higher with the solution compared to the tablets.
Children and adolescents 6 to less than 18 years of age:
For valsartan tablets, the initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response and tolerability. For maximum doses studied in clinical trials please refer to the table below.
Doses higher than those listed have not been studied and are therefore not recommended.
| Weight | Maximum dose studied in clinical trials |
|---|---|
| ≥18 kg to <35 kg | 80 mg |
| ≥35 kg to <80 kg | 160 mg |
| ≥80 kg to ≤160 kg | 320 mg |
For children already started on valsartan prior to the age of six years, please refer to the posology for valsartan oral solution (Children 1 to less than 6 years of age).
Children less than 6 years of age:
For children aged 1 to 5 years and for those having difficulties in swallowing the tablet, valsartan oral solution isrecommended. Available data are described in sections 4.8 and 5.1. The safety and efficacy of valsartan in childrenbelow 1 year of age have not been established.
Switching from valsartan oral solution to valsartan tablets:
If switching from valsartan oral solution to valsartan tablets is considered clinically essential, initially the same dose in milligrams should be given. Subsequently, frequent blood pressure monitoring should be performed taking into account potential under-dosing and the dose should be titrated further based on blood pressure response and tolerability.
Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients. No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min. Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
As in adults, Valsartan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2). There is limited clinical experience with Valsartan in paediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
Valsartan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Valsartan may be taken independently of a meal and should be administered with water.
Overdose with Valsartan 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.
3 years.
This medicinal product does not require any special storage conditions.
Valsartan film-coated tablets are presented in the following pack types.
HDPE bottle pack (marketable pack) comprises of white HDPE bottle with white opaque polypropylene closure with induction sealing liner.
Cold form blister pack (marketable pack) comprises of cold form laminate (aluminium foil laminated to oriented polyamide on one side and to PVC on the other side i.e. OPA/Al/PVC) on one side and hard tempered aluminium foil coated with heat seal lacquer on the other side.
PVC/PE/PVDC-Aluminium triplex blister pack.
Valsartan is available in blister packs of 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets, and HDPE bottles containing 28, 56, 98, 500, 1000 tablets. Not all pack sizes may be marketed. Valsartan 160 mg and 320 mg is also available in blister multipack containing 98 (2 packs of 49) tablets.
No special requirements for disposal.
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