Dosing & Uses
Dosage Forms & Strengths
80-160 mg/day PO
Maintenance: 80-320 mg/day PO
Congestive Heart Failure
40 mg PO q12hr
Maintenance: 40-160 mg PO q12hr; not to exceed 320 mg/day
Post-MI Therapy in Left Ventricular Dysfunction
May be initiated >12 hours after myocardial infarction (MI)
20 mg PO q12hr initially, 12 hrs after MI, then increased to 40 mg PO q12hr within 7 days
Maintenance: Titrated to 160 mg PO q12hr as tolerated
Although food may decrease absorption (by 40%), manufacturer states drug may be administered without regard to meals
Drug may also be given in combination with hydrochlorothiazide (Diovan HCT) or amlodipine (Exforge)
- CrCl ≥30 mL/min: No dose adjustment necessary in adults
- CrCl <30 mL/min: Use with caution in adults; not studied in children
- Mild to moderate liver impairment: No adjustment necessary; use with caution in liver disease
- Severe liver impairment: Not studied
Generally, adjust dosage monthly (maximal reduction of BP attained after 4 weeks); adjust more aggressively in high-risk patients and patients with cormorbidities
Serious - Use Alternative
Significant - Monitor Closely
Dizziness (17%; heart failure)
Increased blood urea nitrogen (BUN; 17%)
Dizziness (2-8%; hypertension)
Hypotension (1-7%; heart failure)
Viral infection (3%)
Upper abdominal pain (>1%)
Frequency Not Defined
Hypersensitivity: Angioedema (rare)
Digestive: Elevated liver enzymes, hepatitis (rare)
Renal: Impaired renal function, renal failure
Clinical laboratory tests: Hyperkalemia
Dermatologic: Alopecia, bullous dermatitis
Blood and lymphatic: Thrombocytopenia (rare)
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
Do not coadminister with aliskiren in patients with diabetes mellitus
Use caution in hereditary angioedema, volume depletion, severe congestive heart failure (CHF), hyperkalemia, hepatic or renal impairment, aortic or mitral valve stenosis, surgery, anesthesia
Discontinue immediately if patient is pregnant; potential risk of congenital abnormalities
Concomitant use with angiotensin-converting enzyme (ACE) inhibitor and beta blocker is not recommended in CHF patients
Post-MI treatment: Consider dosage reduction if hypotension or renal dysfunction occurs after MI
Angioedema, hypotension, hyperkalemia, and renal function deterioration may occur; monitor
Dosage reduction or discontinuance may be required if hyperkalemia or increased serum creatinine occurs
Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis
Dual blockade of the renin-angiotensin system with angiotensin-receptor blockers (ARBs), ACE inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy; closely monitor blood pressure
Avoid coadministration with aliskiren in patients with renal impairment (ie, GFR <60 mL/min/1.73 m²)
Pregnancy & Lactation
Pregnancy category: D
Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, resulting oligohydramnios may cause fetal injury (eg, hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure) and death
Neonates with a history of in utero exposure: Direct attention toward support of blood pressure and renal perfusion; exchange transfusions or dialysis may be required
Lactation: No human data; use with caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Blocks binding of angiotensin II to type 1 angiotensin II receptors, causing a lowering in blood pressure; blocks vasoconstrictor and aldosterone-secreting effects of angiotensin II
Onset: 2 hr
Duration: 24 hr
Peak serum time: 2-4 hr
Peak response: 4-6 hr
Protein bound: 94-95%
Vd: 17 L
Minimally metabolized in liver
Metabolites: Valeryl-4-hydroxyvalsartan (inactive)
Half-life: 6-9 hr
Renal clearance: 0.62 L/hr
Total body clearance: 2.2 L/hr
Excretion: Feces (83%), urine (13%)
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.