Valsartan/​Amlodipine

DEA Class; Rx

Common Brand Names; Exforge

• ARB/CCB Combos

Dihydropyridine calcium-channel blocker (amlodipine) combined with angiotensin II antagonist (valsartan); both drugs have long half-lives allowing for qd dosing; used primarily for tx of HTN after titration of individual drugs.

Indicated for the treatment of hypertension.

Hypersensitivity to valsartan, amlodipine, or excipients

Concomitant administration with aliskiren in patients with diabetes mellitus

• Headache
• Increased BUN (6-17%)
• 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%)
• Orthostatic hypotension
• Syncope
• Visual disturbance
• Tinnitus
• Exanthema
• Rhabdomyolysis

Drugs that inhibit renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically; some patients with heart failure have developed increases in potassium with valsartan therapy; these effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment; dosage reduction and/or discontinuation of therapy may be required

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

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

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

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