Valsartan is used for management of hypertension (alone or in combination with other classes of antihypertensive agents); may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.
Angiotensin II receptor antagonists are one of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.
Angiotensin II receptor antagonists can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.
CHF
Angiotensin II receptor antagonists are second-line agents in the treatment of CHF; should be used only in those intolerant of ACE inhibitors.
No additional therapeutic benefit when used as combination therapy with an ACE inhibitor.
Heart Failure or Left Ventricular Dysfunction after Acute MI
Valsartan is used to reduce the risk of cardiovascular mortality in clinically stable patients who have demonstrated clinical signs of CHF or left ventricular dysfunction following MI.
Most experts state that angiotensin II receptor antagonists should be used only in those intolerant of ACE inhibitors.
Valsartan may be given with other standard post-MI therapy (e.g., thrombolytics, aspirin, β-adrenergic blocking agents, hydroxymethylglutaryl-CoA [HMG-CoA] reductase inhibitors [statins]).
Diabetic Nephropathy
Angiotensin II receptor antagonists or ACE inhibitors are first-line agents in the treatment of diabetic nephropathy† in patients with type 2 diabetes mellitus and hypertension.
Dosage and Administration
General
Hypertension
Fixed-combination valsartan/hydrochlorothiazide tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP. Consider potential benefits and risks of initiating therapy with the fixed combination of valsartan and hydrochlorothiazide. Not recommended as initial therapy in patients who are volume depleted.
If the patient's baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 41, 50, or 84% and of achieving DBP control (DBP <90 mm Hg) is 60, 57, or 80% with valsartan (320 mg daily) alone, hydrochlorothiazide (25 mg daily) alone, or valsartan combined with hydrochlorothiazide (at same dosages), respectively.
Fixed-combination valsartan/amlodipine tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP. Consider potential benefits and risks of initiating therapy with the fixed combination of valsartan and amlodipine, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs.
If the patient's baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 47, 67, or 80% and of achieving DBP control (DBP <90 mm Hg) is 62, 80, or 85% with valsartan (320 mg daily) alone, amlodipine (10 mg daily) alone, or valsartan combined with amlodipine (at same dosages), respectively.
CHF
Concomitant use of angiotensin II receptor antagonists (e.g., valsartan) with ACE inhibitors and β-adrenergic blocking agents not recommended (increased heart failure morbidity observed in clinical trial).
Administration
Oral Administration
Administer valsartan orally once or twice daily without regard to meals.
Administer valsartan as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets or in those for whom the calculated daily dosage does not correspond to the available tablet strengths.
Reconstitution
Preparation of extemporaneous suspension containing valsartan 4 mg/mL: Add 80 mL of suspending vehicle (e.g., Ora-Plus®) to an amber glass bottle containing 8 valsartan 80-mg tablets; shake the contents for ≥2 minutes. Allow concentrated suspension to stand for ≥1 hour, then shake for ≥1 additional minute. Dilute the concentrated suspension with 80 mL of sweetening vehicle (e.g., Ora-Sweet SF®); shake the contents for ≥10 seconds. Shake suspension for ≥10 seconds before dispensing each dose.
Dosage
Pediatric Patients
Hypertension
Valsartan Therapy for Hypertension
Oral
Children 6–16 years of age: Initially, valsartan 1.3 mg/kg (up to 40 mg) once daily. Adjust dosage according to patient response. Dosages >2.7 mg/kg (up to 160 mg) once daily have not been studied in children.
May need to increase dosage when converting from extemporaneously prepared suspension to oral tablet, since exposure to valsartan with the suspension is 1.6 times greater than with the tablet.
Adults
Hypertension
Valsartan Therapy for Hypertension
Oral
Initially, valsartan 80 or 160 mg once daily in adults without intravascular volume depletion. Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.
Usual valsartan dosage: 80–320 mg given once daily. However, at dosages >80 mg daily, addition of diuretic produces greater BP reduction than increases in valsartan dosage.
Valsartan/Amlodipine Fixed-combination Therapy for Hypertension
Oral
In studies using valsartan/amlodipine fixed combination in dosages of valsartan 160–320 mg daily and amlodipine 5–10 mg daily, BP response increased with increasing dosages of the drugs.
If BP is not adequately controlled by monotherapy with valsartan (or another angiotensin II receptor antagonist) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to the fixed-combination preparation containing valsartan 160 mg and amlodipine 5 or 10 mg or, alternatively, valsartan 320 mg and amlodipine 5 or 10 mg.
If dose-limiting adverse effects have developed during monotherapy with valsartan or amlodipine, can switch to a fixed combination containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient's response after 3–4 weeks of therapy.
If BP is controlled with valsartan and amlodipine (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.
When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is valsartan 160 mg and amlodipine 5 mg daily in those who are not volume depleted.
Increase to maximum dosage of valsartan 320 mg and amlodipine 10 mg daily, if needed, to control BP. May adjust dosage at intervals of 1–2 weeks, since most of the antihypertensive effect of a given dosage is achieved within 2 weeks after a change in dosage.
Valsartan/Hydrochlorothiazide Fixed-combination Therapy for Hypertension
Oral
If BP is not adequately controlled by monotherapy with valsartan (or another angiotensin II receptor antagonist) or hydrochlorothiazide, can switch to fixed-combination tablets containing valsartan 160 mg and hydrochlorothiazide 12.5 mg once daily.
If dose-limiting adverse effects have developed during monotherapy with valsartan or hydrochlorothiazide, can switch to a fixed combination containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient's response after 3–4 weeks of therapy.
If BP is controlled with valsartan and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.
When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is valsartan 160 mg and hydrochlorothiazide 12.5 mg daily in those who are not volume depleted. Adjust dosage according to patient's response after 1–2 weeks of therapy.
Increase to maximum dosage of valsartan 320 mg and hydrochlorothiazide 25 mg daily, if needed, to control BP. Maximum antihypertensive effect of a given dosage is achieved within 2–4 weeks after a change in dosage.
CHF
Oral
Initially, valsartan 40 mg twice daily. Increase dosage to 160 mg twice daily (maximum dosage used in clinical trials) or highest tolerated dosage. (See Hypotension under Cautions.)
Heart Failure or Left Ventricular Dysfunction after Acute MI
Oral
Manufacturer states that valsartan therapy may be initiated ≥12 hours post-MI with a dosage of 20 mg twice daily. May increase dosage to 40 mg twice daily within 7 days, with subsequent titration to a target maintenance dosage of 160 mg twice daily, as tolerated.
Consider dosage reduction if symptomatic hypotension or renal dysfunction occurs.
Special Populations
The following information addresses dosage of valsartan in special populations. Dosages of drugs administered in fixed combination with valsartan also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.
Hepatic Impairment
No adjustment of initial valsartan dosage necessary in patients with mild to moderate hepatic impairment. Cautious dosing recommended in patients with hepatic impairment; titrate dosage slowly.
Amount of amlodipine in valsartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.
Renal Impairment
No adjustment of initial valsartan dosage necessary in patients with mild to moderate renal impairment. Cautious dosing recommended in adults with severe impairment; titrate dosage slowly. Use of valsartan in pediatric patients with GFR <30 mL/minute per 1.73 m2 not recommended.
Valsartan/hydrochlorothiazide fixed combination is not recommended in patients with Clcr ≤30 mL/minute. Loop diuretics are preferred to thiazides in these patients.
Geriatric Patients
No adjustment of initial valsartan dosage is necessary.
Amount of amlodipine in valsartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients ≥75 years of age.
Volume- and/or Salt-Depleted Patients
Correct volume and/or salt depletion prior to initiation of valsartan therapy or initiate therapy under close medical supervision.
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