valsartan/amlodipine (Rx)

Brand and Other Names:Exforge
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

amlodipine/valsartan

tablet

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

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

and valsartan/amlodipine

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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

            Rhabdomyolysis

            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

            The drug combination 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/neonate 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 combination for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to the drug combination, 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 drug combination in human milk, effects on breastfed infant, or on milk production; valsartan is present in rat milk; limited published studies report that amlodipine is present in human milk

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

            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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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.