aliskiren/valsartan (Discontinued)

Brand and Other Names:Valturna
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aliskiren/valsartan

tablet

  • 150/160mg
  • 300/320mg
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Hypertension

Add-on OR initial treatment: aliskiren/valsartan 150/160 mg PO qDay

Maintenance: If needed, may increase after 2-4 weeks to maximum of 300/320 mg PO qDay

Majority of effect attained within 2 weeks

Safety and efficacy not established

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Interactions

Interaction Checker

and aliskiren/valsartan

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Cough (1.1%)

            Diarrhea (2.3%)

            Rash (1%)

            Dizziness (1.4%)

            Fatigue (2.6%)

            Hyperkalemia (4%)

            Hypotension (5.5%)

            Nasopharyngitis (2.6%)

            Upper RTI (1.4%)

            UTI (1.4%)

            Vertigo (1.1%)

            <1%

            Angioedema

            Gout

            Headache

            Renal stones

            Postmarketing Reports

            Peripheral edema

            Increased serum creatinine

            Stevens Johnson syndrome

            Toxic epidermal necrolysis

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            Warnings

            Black Box Warning

            Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to aliskiren or valsartan

            Pregnancy (2nd and 3rd trimesters): significant risk of fetal and neonatal morbidity and mortality

            Use in patients with diabetes

            Do not coadminister aliskiren with ARBs or ACEIs in patients with diabetes

            Cautions

            Caution in volume- or salt-depleted patients

            Diabetes mellitus

            Severe renal impairment

            Monitor renal function periodically

            Renal artery stenosis

            Hepatic impairment

            Monitor for hypotension

            Reports of aliskiren-associated head/neck angioedema

            Cyclosporine or itraconazole increase aliskiren levels; avoid concomitant use

            Coadministration with NSAIDs increase risk for renal impairment; monitor renal function periodically

            Coadministration of aliskiren with ACE inhibitors or ARBs

            • Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
            • When aliskiren was prescribed with ACE inhibitors or angiotensin receptor blockers (ARBs) in the ALTITUDE study, an increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension was observed after 18-24 months
            • The ALTITUDE trial included patients with hypertension plus type 2 diabetes and renal impairment who were at high risk of cardiovascular and renal events
            • FDA notified healthcare professionals of possible risks when using aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. Their use is contraindicated in patients with diabetes. Avoid use of aliskiren with ARBs or ACEIs in moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min)
            • Hyperkalemia: Increases in serum potassium >5.5 mEq/L were infrequent with aliskiren (0.9% compared to 0.6% with placebo); however, when used in combination with an ACE inhibitor in a diabetic population, increases in serum potassium were more frequent (5.5%)
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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)

            Lactation: discontinue drug or do not nurse

            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

            Aliskiren: Renin inhibitor

            Valsartan: Blocks binding of angiotensin II to type 1 angiotensin II receptors

            Absorption

            Bioavailability: (aliskiren) 2.5%; (valsartan) 25%

            Peak Response: (valsartan) 4-6 hr

            Peak Plasma Time: (valsartan) 2-4 hr; (aliskiren) 1-3 hr

            Onset: (valsartan) 2 hr

            Duration: (valsartan) single dose: 6-8 hr, multiple dose: 24 hr

            Distribution

            Protein Bound: (valsartan) 94-95%

            Vd: (valsartan) 17 L

            Metabolism

            Valsartan metabolized minimally in liver; aliskiren metabolized by CYP3A4

            Metabolites: (valsartan) valeryl-4-hydroxyvalsartan (inactive)

            Elimination

            Half-Life: (valsartan) 6-9 hr; (aliskiren) 24 hr

            Total body clearance: (valsartan) 2.2 L/hr

            Total renal clearance: (valsartan) 0.62 L/hr

            Excretion: (valsartan) feces 83% (89% in bile), urine 7-13%; (aliskiren) urine

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