valsartan (Rx)

Brand and Other Names:Diovan, Prexxartan
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 40mg
  • 80mg
  • 160mg
  • 320mg

oral solution (Prexxartan)

  • 4mg/mL

Hypertension

Indicated for treatment of hypertension by lowering blood pressure (BP)

Initial

  • Monotherapy in patients not volume-depleted: 40-80 mg PO BID
  • Patients requiring greater BP reduction: 80 mg PO BID

Maintenance

  • Antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks
  • If additional antihypertensive effect required beyond the starting dose, the total daily dose may be increased to a maximum of 320 mg or a diuretic may be added
  • Addition of a diuretic has a greater effect than dose increases beyond 80 mg
  • Total daily dose range: 80-320 mg/day
  • May be administered with other antihypertensives

Heart Failure

Indicated for the treatment of heart failure (NYHA class II-IV) to reduce the risk of hospitalization for heart failure in patients unable to swallow valsartan tablets

Initial: 40 mg PO q12hr

Titrate to 80 mg and 160 mg BID, as tolerated

Consider reducing dose of concomitant diuretics

Not to exceed 320 mg/day

Post-Myocardial Infarction

Indicated to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (MI) who are unable to swallow valsartan tablets

May be initiated as early as 12 hours after MI

20 mg PO q12hr initially, then increased to 40 mg PO q12hr within 7 days, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated

If symptomatic hypotension or renal dysfunction occurs, consider dose reduction

May be administered with other standard post-MI treatment including thrombolytics, aspirin, beta-blockers, and statins

Dosage Modifications

Renal impairment

  • CrCl ≥30 mL/min: No dose adjustment necessary in adults
  • CrCl <30 mL/min: Safety and efficacy not established

Hepatic impairment

  • Mild-to-moderate liver impairment: No adjustment necessary; use with caution in liver disease
  • Severe liver impairment: Not studied

Dosing Considerations

Generally, adjust dosage monthly (maximal reduction of BP attained after 4 weeks); adjust more aggressively in high-risk patients and patients with comorbidities

Dosage Forms & Strengths

tablet

  • 40mg
  • 80mg
  • 160mg
  • 320mg

oral solution (Prexxartan)

  • 4mg/mL

Hypertension

Indicated for treatment of hypertension by lowering blood pressure (BP) in children aged 6-16 years

<6 years: Safety and efficacy not established

6-16 years

  • Initial: 0.65 mg/kg PO BID; not to exceed 40 mg/day  
  • Adjust according to blood pressure response
  • Doses >1.35 mg/kg BID (ie, >160 mg/day) have not been studied in children

Dosage Modifications

Renal impairment

  • In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated
  • GFR <30 mL/min/1.73m² or hemodialysis: No data are available

Hepatic impairment

  • Mild-to-moderate: Limited clinical experience
  • Severe: No dosing recommendation can be provided
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Interactions

Interaction Checker

and valsartan

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            Adverse Effects

            >10%

            Dizziness (17%; heart failure)

            Increased blood urea nitrogen (BUN; 17%)

            1-10%

            Hyperkalemia (4-10%)

            Dizziness (2-8%; hypertension)

            Hypotension (1-7%; heart failure)

            Fatigue (3%)

            Viral infection (3%)

            Neutropenia (2%)

            Syncope (>1%)

            Upper abdominal pain (>1%)

            Vertigo (>1%)

            Frequency Not Defined

            Headache

            Cough (rare)

            Postmarketing Reports

            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)

            Vascular: Vasculitis

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            Warnings

            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

            Contraindications

            Hypersensitivity

            Do not coadminister with aliskiren in patients with diabetes mellitus

            Cautions

            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)

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            Pregnancy & Lactation

            Pregnancy

            Use of drugs that act on the renin-angiotensin system during the 2nd and 3rd trimesters of pregnancy reduces renal function and increases fetal and neonatal morbidity and death

            Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations

            Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death

            When pregnancy is detected, discontinue as soon as possible

            Lactation

            Unknown if excreted in milk; not recommended

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 25%

            Onset: 2 hr

            Duration: 24 hr

            Peak serum time: 2-4 hr

            Peak response: 4-6 hr

            Distribution

            Protein bound: 94-95%

            Vd: 17 L

            Metabolism

            Minimally metabolized in liver

            Metabolites: Valeryl-4-hydroxyvalsartan (inactive)

            Elimination

            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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            Administration

            Oral Administration

            May take with or without food

            Oral solution (Prexxartan) is not therapeutically equivalent to the tablet formulation (Diovan); peak concentration of oral solution is higher than with the tablet

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.