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VALSARTAN is a brand name for Valsartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension Treatment of hypertension in children and adolescents 6 to less than 18 years of age. Recent myocardial infarction 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Recent myocardial infarction 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 dose reduction. g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics. 1). Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Heart failure 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. 1). Evaluation of patients with heart failure should always include assessment of renal function.
Additional information on special populations:
Older people No dose adjustment is required in elderly patients. 2). 2). In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Paediatric population Paediatric hypertension Children and adolescents 6 to less than 18 years of age 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.
2. However safety and efficacy of Valsartan in children aged 1 to 6 years have not been established. Use in paediatric patients aged 6 to less than 18 years with renal impairment 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.
In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse drug reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class. Adverse drug reaction Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse drug reactions are ranked in order of decreasing seriousness. For all the ADRs reported from post marketing experience and laboratory finding it is not possible to apply any ADR frequency and therefore they are mentioned with a “not known” frequency.
Hypertension:
Blood and lymphatic system disorders: Not known: Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia Immune system disorders: Not known: Hypersensitivity including serum sickness Metabolism and nutrition disorders: Not known: Increase of serum potassium, hyponatraemia Ear and labyrinth system disorders: Uncommon: Vertigo Vascular disorders: Not known: Vasculitis Respiratory, thoracic and mediastinal disorders: Uncommon: Cough Gastrointestinal disorders: Uncommon: Abdominal pain Very Rare: Intestinal angioedema Hepato-biliary disorders: Not known: Elevation of liver function values including increase of serum bilirubin.
Skin and subcutaneous tissue disorders:
) is not recommended. Monitoring of potassium should be undertaken as appropriate.
Impaired renal function:
There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients. 2).
Sodium- and/or volume-depleted patients:
In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan. Sodium and/or volume depletion should be corrected before starting treatment with valsartan, for example by reducing the diuretic dose.
Renal artery stenosis:
In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of valsartan has not been established. Short-term administration of valsartan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Kidney transplantation:
There is currently no experience on the safe use of valsartan in patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism:
Patients with primary hyperaldosteronism should not be treated with valsartan as their renin-angiotensin system is not activated.
1. - Severe hepatic impairment, biliary cirrhosis and cholestasis. 6). 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min. 2). 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.
Paediatric heart failure and recent myocardial infarction 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.
Method of administration Valsartan may be taken independently of a meal and should be administered with water.
Not known: Angioedema, Dermatitis bullous, Rash, Pruritus Musculoskeletal and connective tissue disorders: Not known: Myalgia Renal and urinary disorders: Not known: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions: Uncommon: Fatigue Paediatric population Hypertension The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies (each followed by an extension period or study) and one open-label study.
These studies included 711 paediatric patients from 6 to less than 18 years of age with and without chronic kidney disease (CKD) of which 560 patients received valsartan. With the exception of isolated gastrointestinal disorders (such as abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to less than 18 years and that previously reported for adult patients.
Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Valsartan for up to one year. A pooled analysis of 560 paediatric hypertensive patients (aged 6-17 years) receiving either valsartan monotherapy [n=483] or combination antihypertensive therapy including valsartan [n=77] was conducted.
73m2). 0%) patients discontinued a study due to adverse events. 3%) being the most frequent. 7%). 7%). ADRs were observed more frequently in patients receiving valsartan in combination with other antihypertensive medications than valsartan alone.
The antihypertensive effect of valsartan in children 1 to less than 6 years of age has been evaluated in three randomised, double-blind clinical studies (each followed by an extension period). In the first study in 90 children aged 1 to less than 6 years, two deaths and isolated cases of marked liver transaminases elevations were observed.
These cases occurred in a population who had significant comorbidities. A causal relationship to Valsartan has not been established. In the two subsequent studies in which 202 children aged 1 to less than 6 years were randomised, no significant liver transaminase elevations or death occurred with valsartan treatment.
In a pooled analysis of the two subsequent studies in 202 hypertensive children (aged 1 to less than 6 years), all patients received valsartan monotherapy in the double blind periods (excluding the placebo withdrawal period). Of these, 186 patients continued in either extension study or open label period.
3%) had CKD (baseline eGFR <90 ml/min). 1%) discontinued due to an adverse event. 0%) patients experienced at least one ADR. 1%). There was one ADR (diarrhoea) in the CKD group. 4% patients (10/186) had at least one ADR. 1%). In both the double blind period and the open label periods, hyperkalaemia was reported for one patient in each period.
There were no cases of hypotension or dizziness in either double blind or open label periods. Hyperkalaemia was more frequently observed in children and adolescents aged 1 to less than 18 years with underlying chronic kidney disease (CKD).
The risk of hyperkalaemia may be higher in children aged 1 to 5 years compared to children aged 6 to less than 18 years. […]
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Pregnancy:
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
6). 1). Therefore, the combination of valsartan with an ACE inhibitor is not recommended. Caution should be observed when initiating therapy in post-myocardial infarction patients. 2). 2). Heart failure The risk of adverse reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may increase when Valsartan is used in combination with an ACE-inhibitor.
1). This combination apparently increases the risk for adverse events and is therefore not recommended. Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and valsartan is also not recommended. Use of these combinations should be under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Caution should be observed when initiating therapy in patients with heart failure. 2). 2). g. patients with severe congestive heart failure), treatment with ACE-inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
As valsartan is an angiotensin II receptor blocker, it cannot be excluded that the use of Valsartan may be associated with impairment of the renal function. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
History of angioedema Angioedema, including swelling of the larynx and glottis, causing airway obstructions and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors.
8). Intestinal angioedema Intestinal angioedema has been reported in patients […]