valsartan (Rx)

Brand and Other Names:Diovan
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 40mg
  • 80mg
  • 160mg
  • 320mg

oral solution (Prexxartan-discontinued)

  • 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: No dosage adjustments provided in the manufacturer’s labeling; use caution
  • Dialysis: Drug is not significantly removed through dialysis

Hepatic impairment

  • Mild-to-moderate liver impairment: No dosage adjustments necessary
  • Severe liver impairment: No dosage adjustments provided in the manufacturer’s labeling

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-discontinued)

  • 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

  • GFR ≥30 mL/min/1.73m²: No dosage adjustment necessary
  • GFR <30 mL/min/1.73m² or hemodialysis: No dosage adjustments provided in the manufacturer’s labeling; not studied; use not recommended

Hepatic impairment

  • Mild-to-moderate: Limited clinical experience; not dosage adjustment necessary
  • 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

            Coadministration with aliskiren in patients with diabetes mellitus

            Cautions

            Use caution in hereditary angioedema, volume depletion, severe congestive heart failure (CHF), hepatic or renal impairment, aortic or mitral valve stenosis, surgery, anesthesia

            In heart failure may need to adjust dose and/or concurrent diuretic therapy because of valsartan-induced hypotension; if pre-existing renal disease exists, monitor serum creatinine, blood urea nitrogen, and potassium

            Discontinue therapy immediately if angioedema occurs; may be necessary to administer epinephrine intramuscularly; not for administration to patients who developed angioedema when treated with angiotensin receptor blockers

            Therapy can cause fetal harm when administered during pregnancy; 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, hyperkalemia, and renal function deterioration may occur; monitor; the most common adverse reaction in children <6 years has been hyperkalemia, especially in children with renal disease

            Symptomatic hypotension may occur upon initiation in patients who are salt or volume depleted (eg, patients in high dose diuretics); correct volume depletion prior to administration

            Hyperkalemia may occur; risk factors include renal dysfunction, concomitant use with potassium-sparing diuretics, diabetes mellitus, potassium supplements, and/or potassium-containing salts; dosage reduction or discontinuance may be required if hyperkalemia or increased serum creatinine occurs

            In patients with low renal blood flow, including renal artery stenosis or heart failure, therapy may be associated with deterioration of renal function and/or increases in serum creatinine; 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)

            Avoid use in patients with refractory ascites or patients with ascites due to cirrhosis; if therapy must be administered monitor blood pressure and renal function carefully

            Can cause fetal harm when administered to pregnant women; when pregnancy detected, discontinue as soon as possible (see Black Box Warnings, Pregnancy)

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            Pregnancy & Lactation

            Pregnancy

            The drug can cause fetal harm when administered to a pregnant woman; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

            Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents

            When pregnancy is detected, discontinue therapy as soon as possible

            Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage)

            Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Fetal/neonatal adverse reactions

            • Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death
            • Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; oligohydramnios may not appear until after the fetus has sustained irreversible injury
            • If oligohydramnios is observed, consider alternative drug treatment; closely observe neonates with histories of in utero exposure to the drug for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to the drug, if oliguria or hypotension occurs, support blood pressure and renal perfusion
            • Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function

            Lactation

            There is limited information regarding presence of the drug in human milk, effects on breastfed infant, or on milk production; the drug is present in rat milk

            Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug

            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.
            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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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.