DIOVAN® NSS - UAE
DIOVAN® NSS - UAE
Regulatory Affairs
DIOVAN® (valsartan)
40 mg, 80 mg, 160 mg and 320 mg Film-coated tablets
National Succinct Statement
Version 4.0
Effective date: 01-Feb-2021
Safety Label Change
(SLC) Not Applicable
Tracking number:
Document status: Final
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May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Diovan®
Important note: Before prescribing, consult full prescribing information. link to the reference country website: https://www.swissmedicinfo.ch/
This link will contain the most updated product information approved by the reference country.
Presentation: Valsartan: film-coated tablets of 40 mg, 80 mg, 160 mg and 320 mg
Indications/Potential uses
Essential hypertension
Treatment of mild and moderate essential hypertension in adults and in children and adolescents 6 to 18 years of age.
Heart failure
Mild to moderate heart failure (NYHA II and III) in adults, normally in combination with diuretics and digitalis, if treatment with ACE inhibitors is unsuitable due to side effects specific to ACE inhibitors (coughing) or in patients who are intolerant to beta blockers as an add-on therapy to ACE inhibitors if mineralocorticoid receptor antagonists cannot be used. Adverse effects of ACE inhibitor therapy that result from a general influence on the renin- angiotensin-aldosterone system (e.g. progressive renal failure, hyperkalaemia) are not an indication for Diovan.
Post-acute myocardial infarction
Long-term prophylaxis in adult patients in stable condition following myocardial infarction associated with left-ventricular dysfunction and ejection fraction ≤40%.
Dosage/Administration
Usual dosage
Essential hypertension
The recommended dose of Diovan is 80 mg or 160 mg once daily, irrespective of race, age or gender.
A substantial antihypertensive effect is achieved within 2 weeks, and the maximum antihypertensive effect within 4 weeks of commencing treatment. If the reduction in blood pressure is insufficient, the daily dose may be increased to 160 mg or to a maximum of 320 mg as a film-coated tablet, or a diuretic may be added.
Diovan may be administered with other antihypertensive agents.
Heart failure
The recommended starting dose is 40 mg valsartan twice daily as a film-coated tablet. Depending on tolerability, the dose should be increased gradually, first to 80 mg valsartan twice daily, then to 160 mg valsartan twice daily as a film-coated tablet. If a diuretic is administered concomitantly, consideration should be given to reducing the dose of the diuretic. In clinical trials, the maximum daily dose was 320 mg valsartan (160 mg valsartan twice daily).
Monitoring of patients with heart failure should always include assessment of renal function.
Post-acute myocardial infarction
Treatment with Diovan may be started as early as 12 hours after acute myocardial infarction. After an initial dose of 20 mg twice daily, the dose should be gradually increased (generally over a few weeks) to 40 mg, 80 mg or 160 mg film-coated tablets twice daily. The starting dose can be achieved using the 40 mg divisible film-coated tablet.
The maximum target dose is 160 mg twice daily. In general, it is recommended that patients reach the dosage of 80 mg twice daily 2 weeks after starting treatment and the maximum target dosage after 3 months, depending on individual tolerability during dose escalation.
In the event of symptomatic hypotension or renal impairment, dose reduction should be considered.
Diovan may be co-administered with other medicines used following acute myocardial infarction, e.g. thrombolytics, acetylsalicylic acid, beta blockers or statins.
Monitoring of post-acute myocardial infarction patients should always include assessment of renal function.
Patients with hepatic impairment
In patients with hepatic impairment, the daily dose should not exceed 80 mg valsartan.
Patients with renal impairment
NOTE for all indications: No dose adjustment is required for patients with mild to moderate renal impairment.
Children and adolescents
Film-coated tablets
The initial dose is one 40 mg film-coated tablet once daily for children weighing below 35 kg and 80 mg once daily for children and adolescents weighing 35 kg or more. The dose should be adjusted based on blood pressure response. 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.
Body weight | Maximum doses 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 |
Solution
For children and adolescents who are unable to swallow film-coated tablets, the use of Diovan oral solution is recommended. Systemic exposure and peak plasma concentration with the solution are, respectively, 1.7 and 2.2 times the values obtained after taking the film-coated tablets.
The initial dose of Diovan oral solution is 20 mg (corresponding to 7 ml of solution) once daily for children and adolescents weighing less than 35 kg and 40 mg (corresponding to 13 ml of solution) once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response up to a maximum of 40 mg valsartan (corresponding to 13 ml of solution) once daily in children and adolescents weighing less than 35 kg and 80 mg valsartan (corresponding to 27 ml of solution) once daily for those weighing 35 kg or more.
It is not recommended to switch between Diovan film-coated tablets and Diovan oral solution unless clinically required. If switching from Diovan film-coated tablets to Diovan oral solution is considered necessary on clinical grounds, the valsartan dose should be adjusted as described in the table below and blood pressure should be carefully monitored. The dose should be titrated based on blood pressure response and tolerability.
Film-coated tablets | Solution | |
Valsartan dose | Valsartan dose to administer when switching | Volume to take |
40 mg | 20 mg | 7 ml |
80 mg | 40 mg | 13 ml |
160 mg | 80 mg | 27 ml |
320 mg | Due to the high volume of solution that would be necessary, use of the solution is not recommended | Not applicable |
If switching from Diovan oral solution to Diovan film-coated tablets is considered clinically necessary, 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 children under 6 years of age
The available data are presented under the headings “Properties/Actions” and/or “Pharmacokinetics”. However, the safety and efficacy of Diovan have not been established in children 1 to 6 years of age.
Patients with other underlying conditions
Diovan 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
Film-coated tablets: Diovan can be taken with or without food and should be administered with water.
Solution: Diovan can be taken with or without food (see “Pharmacokinetics – Absorption”). It is recommended that Diovan be taken at the same time every day, e.g. in the morning for hypertension and morning and evening for heart failure or post-myocardial infarction.
Contraindications:
♦ Known hypersensitivity to valsartan or any of the other components of this product,
♦ Pregnancy and Breast-feeding
♦ Concomitant use with aliskiren in diabetic patients.
Warnings & Precautions:
♦ Risk of hypotension in sodium- and/or volume-depleted patients.
♦ Caution is advised when administering valsartan to patients with renal artery stenosis, severe
renal impairment (creatinine clearance < 10 mL/min), biliary cirrhosis or obstruction.
♦ Caution should be observed when initiating therapy in patients with heart failure or post- myocardial infarction.
♦ In patients with heart failure, caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and Diovan.
♦ In patients with severe heart failure, treatment with Diovan may cause impairment of renal function.
♦ Caution in patients experiencing angioedema with Diovan or having history of angioedema with other drugs. Diovan should be discontinued and not re-administered.
♦ Not recommended in children with glomerular filtration rate <30 mL/min and/or undergoing dialysis. Monitoring of renal function and serum potassium especially in the presence of other conditions (fever, dehydration) likely to impair renal function
♦ Particular caution in children with biliary obstructive disorders
♦ Change of pharmaceutical form not recommended as the forms are not bioequivalent. When clinically essential to switch from FCT to OS, follow CDS recommendation.
♦ Concomitant use with aliskiren in patients with severe renal impairment (GFR < 30 mL/min) should be avoided.
♦ Caution is required while co-administering Diovan with other agents blocking the RAS such as ACEIs or aliskiren..
Pregnancy, lactation, females and males of reproductive potential:
♦ Contraindicated in pregnancy.
♦ Should not be used in women planning to become pregnant and while breast-feeding.
Adverse reactions:
In Hypertensive patients:
♦ Uncommon: Vertigo, cough, abdominal pain, fatigue
♦ Frequency not known: Hypersensitivity including serum sickness, vasculitis, angioedema, dermatitis bullous, rash, pruritus, myalgia, renal failure and impairment, haemoglobin decreased, haematocrit decreased, neutropenia, thrombocytopenia, blood potassium increased, liver function test abnormal including bilirubin increased, blood creatinine increased
♦ Events also observed during clinical trials irrespective of their causal association with the study drug: Arthralgia, asthenia, back pain, diarrhoea, dizziness, headache, insomnia, libido decrease, nausea, oedema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.
In treatment of HTN patients with IGT at CV risk, the adverse reactions are similar as in HTN patients.
In treatment of HTN in children with underlying chronic kidney disease, hyperkalaemia has been observed.
In Post-Myocardial Infarction and/or Heart Failure patients:
♦ Common: Dizziness, postural dizziness, hypotension, orthostatic hypotension, renal failure and impairment
♦Uncommon: Hyperkalaemia, syncope, headache, vertigo, cardiac failure, cough, nausea, diarrhoea, angioedema, acute renal failure, blood creatinine increased, asthenia, fatigue
♦Frequency not known: Hypersensitivity including serum sickness, vasculitis, dermatitis bullous, rash, pruritus, myalgia, thrombocytopenia, blood potassium increased, liver function test abnormal, blood urea increased
♦ Events also observed during clinical trials irrespective of their causal association with the study drug: Arthralgia, abdominal pain, back pain, insomnia, libido decrease, neutropenia, oedema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections. Interactions:
Concomitant administration with other agents blocking the RAS such as ACEIs or aliskiren may increase incidence of hypotension, hyperkalemia and changes in renal function. Monitoring blood pressure, renal function and electrolytes is recommended when used concomitantly.
♦ Concomitant treatment with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that may increase potassium levels (heparin etc.,) may increase serum potassium levels. Monitoring of serum potassium advised
♦ Concomitant treatment with NSAIDs including Cox-2 Inhibitors may decrease antihypertensive effects. In elderly, volume depleted or compromised renal function patients, monitoring of renal function recommended when concomitant use.
♦Co-administration of inhibitors of the uptake transporter (rifampin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
♦ Concomitant treatment with lithium may increase lithium concentrations and toxicity. Close monitoring of serum lithium levels is recommended.
♦ Caution in children with concomitant use of valsartan and other substances inhibiting the renin angiotensin aldosterone system which may increase serum potassium. Monitoring of renal function and serum potassium needed