valsartan (Rx)

Brand and Other Names:Diovan
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 40mg
  • 80mg
  • 160mg
  • 320mg

Hypertension

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

Patients who are not volume-depleted: 80-160 mg PO qDay initially; dosing range 80-320 mg qDay

May increase to a maximum of 320 mg/day or a diuretic may be added if additional antihypertensive effect is required

Antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks

Addition of a diuretic has a greater effect than dose increases >80 mg

Heart Failure

Indicated to reduce risk of hospitalization for patients with heartfailure (NYHA class II-IV)

40 mg PO BID initially; may titrate to 80-160 mg BID, as tolerated

Consider reducing dose of concomitant diuretics

In clinical trials, maximum daily dose administered 320 mg in divided doses

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)

May be initiated as early as 12 hr after MI

20 mg PO BID initially; may increase to 40 mg PO BID 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 administer with other standard post-MI treatment (eg, thrombolytics, aspirin, beta-blockers, statins)

Dosage Modifications

Renal impairment

  • CrCl ≥30 mL/min: No dose adjustment necessary
  • 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

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

1.3 mg/kg qDay (up to 40 mg total); adjust dosage according to blood pressure response  

Doses >2.7 mg/kg (up to 160 mg) qDay have not been studied in pediatric patients 6-16 years old

Dosage Modifications

Renal impairment

  • GFR ≥30 mL/min/1.73m2: No dosage adjustment necessary
  • GFR <30 mL/min/1.73m2 or hemodialysis: No data available

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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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hypertension, adult

            • Dry cough

            Heart failure

            • Increased BUN ≥50% (16.6%)
            • Dizziness (17%)
            • Hypotension (7%)
            • Diarrhea (5%)
            • Arthralgia (3%)
            • Fatigue (3%)
            • Back pain (3%)
            • Dizziness, postural (2%)
            • Hyperkalemia (2%)
            • Hypotension, postural (2%)

            1-10%

            Heart failure

            Increased serum creatinine ≥50% (3.9%)

            • >1%
              • Headache
              • Nausea
              • Renal impairment
              • Syncope
              • Blurred vision
              • Upper abdominal pain
              • Vertigo

            Post MI H4

            • Increased serum creatinine ≥50% (4.2%)
            • Neutropenia (1.9%)
            • Hypotension NOS (1.4%)

            <1%

            Post MI

            • Cough (0.6%)
            • Increased blood creatinine (0.6%)
            • Rash NOS (0.2%)

            Postmarketing Reports

            • Hypersensitivity: Angioedema reported
            • Digestive: Elevated liver enzymes and very rare reports of hepatitis
            • Musculoskeletal: Rhabdomyolysis
            • Renal: Impaired renal function, renal failure
            • Dermatologic: Alopecia, bullous dermatitis
            • Blood and Lymphatic: Thrombocytopenia
            • Vascular: Vasculitis
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            Warnings

            Black Box Warnings

            Fetal toxicity

            • Discontinue immediately when pregnancy is detected
            • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

            Contraindications

            Hypersensitivity

            Coadministration with aliskiren in patients with diabetes mellitus

            Cautions

            May cause fetal harm when administered to pregnant females

            Changes in renal function including acute renal failure may occur; monitor renal function periodically

            Some patients with heart failure have developed increases in potassium; effects are more likely to occur in patients with pre-existing renal impairment; consider a dosage reduction and/or discontinuation

            Hypotension

            • Excessive hypotension rarely occurs in patients with uncomplicated hypertension
            • Symptomatic hypotension may occur in patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur
            • If excessive hypotension occurs, place patient in supine position and, if necessary, give IV 0.9 NaCl
            • A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once stabilized

            Drug interaction overview

            • Agents increasing serum potassium
              • Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine
            • Non-steroidal anti-inflammatory agents (NSAIDs)
              • NSAID, including selective cyclooxygenase-2 inhibitors (COX-2 Inhibitors), use may lead to increased risk of renal impairment and loss of antihypertensive effect
            • Dual inhibition of the renin-angiotensin system
              • Avoid use
              • Dual blockade of renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function
              • Closely monitor BP, renal function and electrolytes when treated with agents that affect the RAS
              • Do not coadminister with aliskiren in patients with diabetes or patients with renal impairment (GFR <60 mL/min)
            • Lithium
              • Increases in serum lithium level and lithium toxicity reported; monitor serum lithium levels
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            Pregnancy & Lactation

            Pregnancy

            Fetal harm may occur when administer in pregnant females

            Use of drug that act on the RAS during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

            When pregnancy is detected, discontinue therapy as soon as possible

            Disease-associated maternal and/or embryofetal risk

            • Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and postpartum hemorrhage)
            • Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; carefully monitor pregnant women with hypertension and managed accordingly

            Fetal/neonatal adverse reactions

            • Oligohydramnios in pregnant women who use drugs affecting the RAS 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 gestation week; oligohydramnios may not appear until after the fetus has sustained irreversible injury
            • If oligohydramnios is observed, consider alternative therapy; 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 BP 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 on drug presence in human milk, effects on breastfed infant, or on milk production

            Detected in milk of lactating rats 15 min after oral administration of a 3 mg/kg-dose

            Breastfeeding is not recommended during treatment

            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

            Peak plasma time: 2-4 hr

            Absolute bioavailability: ~25%

            Effect of food

            • Tablet: Food decreases AUC by ~40% and peak plasma concentration by ~50%

            Distribution

            Vd (steady-state); 17 L (IV)

            Protein bound: 95% (mainly albumin)

            Metabolism

            Metabolized by CYP2C9

            Primary metabolite: Valeryl 4-hydroxy valsartan (~9% of dose)

            Elimination

            Half-life (IV): ~6 hr

            Excretion (oral solution): ~83% (feces); ~13% (urine); recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolite

            Clearance

            • IV: 0.62 L/hr (renal); 2 L/hr (plasma)
            • PO: 4.5 L/hr

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            Administration

            Extemporaneous oral suspension preparation

            Add 80 mL of Ora-Plus to an amber glass bottle containing 8 valsartan 80-mg tablets, and shake for a minimum of 2 min

            Allow suspension to stand for a minimum of 1 hr

            After, shake suspension for a minimum of 1 additional min

            Add 80 mL of Ora-Sweet SF to the bottle and shake suspension for at least 10 sec to disperse the ingredients; suspension is homogenous

            Shake bottle well (at least 10 sec) before dispensing suspension

            Oral Administration

            May take with or without food

            Extemporaneous oral suspension

            • For patients who cannot swallow tablets, or children for whom calculated dosage (mg/kg) does not correspond to the available tablet strengths
            • Note: When replacing tablet for suspension, valsartan dose may have to be increased
            • Exposure to valsartan with suspension is 1.6x greater than with tablet

            Storage

            Extemporaneous oral suspension

            • Store at room temperature (<30ºC/86ºF) for up to 30 days OR
            • Refrigerate at 2-8ºC (35-46ºF) for up to 75 days in the glass bottle with a child-resistant screw-cap closure

            Tablets

            • Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Protect from moisture
            • Dispense in tight container
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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.

            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.
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.