Valsartan oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of valsartan.
Drugs List
Therapeutic Indications
Uses
Hypertension
Management of post-myocardial infarct in patients with cardiac failure
Treatment of cardiac failure (adjunct)
Treatment of essential hypertension
Improvement of survival following recent (12 hours to 10 days) myocardial infarction in clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction
Treatment of symptomatic heart failure when angiotensin converting enzyme (ACE) inhibitors cannot be used, or as an adjunct to ACE inhibitors when beta blockers cannot be used.
Dosage
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.
Adults
Hypertension
80mg once daily for most patients.
The dose can be increased to 160mg once daily if necessary.
Maximum dose: 320mg once daily.
Some sources suggest that the interval between dose increments should be four weeks.
In patients with depleted intravascular volume (e.g. those treated with high dose diuretics which cannot be reduced) a lower starting dose of 40mg once daily is recommended.
Recent myocardial infarction
Therapy may be initiated 12 hours after a myocardial infarction.
Initial dose: 20mg twice daily (provided by dividing the 40mg tablet which is scored).
Titration doses: 40mg and 80mg twice daily over the next few weeks following treatment initiation.
Target dose: 160mg twice daily, achieved three months after treatment initiation, based on a patients tolerance of valsartan dose titration.
Consider dose reduction if symptomatic hypotension or renal impairment occurs.
Valsartan may be used in patients treated with other post-myocardial infarction therapies (e.g. thrombolytics, aspirin, beta blockers and statins). Combination with ACE inhibitors is not recommended.
Heart failure
Initial dose: 40mg twice daily.
Titration doses: 80mg and 160mg twice daily. Doses should be increased at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Consider a dose reduction when taking concurrent diuretics.
The maximum dose administered in clinical trials was 320mg 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.
Children
Oral solution
It is not recommended to switch between oral solution and tablets unless essential. If a switch is made, one manufacturer suggests that initially the same dose in milligrams should be given. Subsequently, frequent blood pressure monitoring should be performed taking into account the potential under-dosing and the dose titrated according to blood pressure response and patient tolerability.
Hypertension
Children aged 1 to 6 years: 1mg/kg once daily. A dose of 2mg/kg may be considered when faster reduction of blood pressure is needed.
Dose should be adjusted based on blood pressure response and tolerability up to a maximum dose of 4mg/kg once daily.
Children aged 6 to 18 years
Bodyweight less than 35kg: Initial dose of 20mg of the oral solution once daily. The dose should be adjusted based on blood pressure response up to a maximum dose of 40mg daily.
Bodyweight greater than or equal to 35kg: 40mg of the oral solution once daily. The dose should be adjusted based on blood pressure response up to a maximum dose of 80mg daily.
Solid oral dosage forms
It is not recommended to switch between solid oral formulations and oral solution unless essential. If a switch is made, the dose of the oral solution should be half that of the same dose of tablets and titrated based on blood pressure response and patient tolerability.
Hypertension
Children aged 6 to 18 years
Bodyweight less than 35kg: Initial dose of 40mg of the tablets once daily.
Bodyweight greater than or equal to 35kg: 80mg of the tablets once daily. Adjust dose based on blood pressure response.
Recommended maximum dosages of the tablets are:
Children weighing 80kg to 160kg: 320mg.
Children weighing 35kg to 80kg: 160mg.
Children weighing 18kg to 35kg: 80mg.
Patients with Hepatic Impairment
Use with caution in patients with mild to moderate hepatic impairment without cholestasis. The dose should not exceed 80mg in this population.
Additional Dosage Information
The antihypertensive effect is substantially present within two weeks and maximal effects are seen after four weeks.
Contraindications
Children under 1 year
Biliary cirrhosis
Breastfeeding
Cholestasis
Galactosaemia
Pregnancy
Renal impairment in children 1 to 18 years - creatinine clearance <30ml/min
Severe hepatic impairment
Precautions and Warnings
Children aged 1 to 18 years
Elderly
Aortic stenosis
Bilateral renal artery stenosis
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of angioedema
Hypertrophic obstructive cardiomyopathy
Hyponatraemia
Hypovolaemia
Kidney transplantation
Lactose intolerance
Mitral stenosis
Renal impairment - creatinine clearance below 10ml/minute
Renovascular disorder
Severe congestive cardiac failure
Unilateral stenosis of solitary functioning kidney
Patients with primary aldosteronism may not benefit from this treatment
Switch to more suitable alternative before planned pregnancy
Advise ability to drive/operate machinery may be affected by side effects
Advise patient that first dose hypotension may occur
Afro-Caribbean or black patients may show reduced response
Correct volume and/or salt depletion before initiating therapy
Not all presentations are licensed for all indications
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain sucrose
Adjust dose if switching between solid oral formulations & oral solution
Tablet formulation not suitable for children under 6 years
Evaluate renal function before and during treatment
Monitor serum electrolytes before and during treatment
Monitor serum potassium regularly
Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
Advise patient to seek advice at first indications of pregnancy
Discontinue if angioedema occurs
Not licensed for all indications in all age groups
Advise patient not to take NSAIDs unless advised by clinician
Advise on problems of salt substitutes/high intake of potassium-rich food
In patients whose renal function may depend on the activity of the renin-angiotensin system (e.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 antagonist, it cannot be excluded that the use of this medication may be associated with impairment of the renal function.
Pregnancy and Lactation
Pregnancy
Valsartan is contraindicated during pregnancy.
The manufacturer does not recommend using valsartan during the first trimester. Use of valsartan during second and third pregnancy is contraindicated by the manufacturer. Studies have shown human foetotoxicity and neonatal toxicity following exposure of angiotensin II receptor antagonists (AIIRAs) during the second and third trimesters.
Lactation
Valsartan is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking valsartan. The presence of valsartan in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal pain
Abnormal liver function
Angioedema
Asthenia
Bullous dermatoses
Cardiac failure
Cough
Decrease in haematocrit
Decrease in haemoglobin
Diarrhoea
Dizziness
Elevation of liver enzymes
Fatigue
Gastro-intestinal disturbances
Headache
Hyperkalaemia
Hypersensitivity reactions
Hyponatraemia
Hypotension
Increase in blood urea nitrogen
Myalgia
Nausea
Neutropenia
Postural dizziness
Postural hypotension
Pruritus
Rash
Renal failure
Renal impairment
Serum bilirubin increased
Serum creatinine increased
Serum sickness-like reactions
Syncope
Thrombocytopenia
Vasculitis
Vertigo
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2020
Reference Sources
Summary of Product Characteristics: Diovan oral solution. Novartis Pharmaceuticals UK Ltd. Revised October 2019.
Summary of Product Characteristics: Valsartan 40mg capsules. Dexcel Pharma Ltd. Revised October 2014.
Summary of Product Characteristics: Valsartan 80mg capsules. Dexcel Pharma Ltd. Revised October 2014.
Summary of Product Characteristics: Valsartan 160mg capsules. Dexcel Pharma Ltd. Revised October 2014.
Summary of Product Characteristics: Valsartan 160mg tablets. Macleods Pharma UK Ltd. Revised February 2019.
Summary of Product Characteristics: Valsartan 40mg capsules. Teva UK Ltd. Revised February 2018.
Summary of Product Characteristics: Valsartan 80mg capsules. Teva UK Ltd. Revised February 2018.
Summary of Product Characteristics: Valsartan 160mg capsules. Teva UK Ltd. Revised February 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 January 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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