valsartan/amlodipine (Rx)Brand and Other Names:Exforge

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

amlodipine/valsartan

tablet

  • 5mg/160mg
  • 5mg/320mg
  • 10mg/160mg
  • 10mg/320mg
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Hypertension

Initiate with 5 mg/160 mg PO qDay OR

Substitute for individually titrated components

May increase dose after at least 2 weeks, not to exceed 10 mg/day amlodipine and 320 mg/day valsartan

May be adminsitered concomitantly with other antihypertensive agents

Dosage modifications

Renal impairment

  • Mild or moderate (CrCl >30 mL/min): Dose adjustment not necessary
  • Severe (CrCl <30 mL/min): Not studied

Hepatic impairment

  • Not recommended for initial therapy; amlodipine 2.5 mg is not an available strength with available dosage forms for this drug combination
  • Amlodipine: Exposure is increased with hepatic insufficiency, consider decreasing dose
  • Valsartan: Exposure increased with mild-to-moderate hepatic insufficiency does not require dosage adjustment; unknown for severe hepatic impairment

Safety and efficacy not established

Not recommended for initial therapy; amlodipine 2.5 mg is not an available strength with available dosage forms for this drug combination

Base initial dose on 2.5 mg of amlodipine PO qDay

No overall difference in the efficacy or safety of valsartan has been observed, but greater sensitivity of some older individuals cannot be ruled out

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Interactions

Interaction Checker

valsartan/amlodipine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache

            Increased BUN (6-17%)

            1-10%

            Peripheral edema (5-8%)

            Anxiety (3%)

            Nasopharyngitis (4%)

            Increased potassium (3%)

            Upper respiratory infection (3%)

            Dizziness (2%)

            Somnolence (3%)

            Diarrhea (3%)

            Nausea (3%)

            Abdominal pain (3%)

            Cough (2%)

            <1%

            Orthostatic hypotension

            Syncope

            Visual disturbance

            Tinnitus

            Exanthema

            Postmarketing Reports

            Amlodipine

            • Gynecomastia
            • Jaundice and hepatic enzyme elevations

            Valsartan

            • 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; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to valsartan, amlodipine or other ingredients

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

            Anuria

            Concomitant administration with aliskiren in patients with diabetes mellitus

            Cautions

            Use during the 2nd or 3rd trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Black Box Warnings)

            Excessive hypotension may occur (rare); caution if volume/salt depleted, initiate cautiously in patients with heart failure, recent MI, or those undergoing surgery or dialysis

            Worsening angina and acute MI may occur after starting or increasing amlodipine dose, particularly with severe obstructive CAD

            Peripheral edema may occur within 2-3 weeks of starting therapy (amlodipine)

            Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy

            Patients whose renal function may depend in part on the activity of the renin angiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion)

            May cause hyperkalemia

            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; closely monitor blood pressure

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters). During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

            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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            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.
            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.
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            OR Other Restrictions
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