Indicated for the treatment of hypertension, to lower blood pressure.

Exforge may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Exforge may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily.

Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.

Do not co-administer aliskiren with Exforge in patients with diabetes. Avoid use of aliskiren with Exforge in patients with renal impairment (GFR <60 mL/min).

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. 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 be at particular risk of developing acute renal failure on Exforge.

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.

Some patients with heart failure have developed increases in potassium with valsartan therapy. 

Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.

Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers (e.g. rifampicin, St. John’s Wort).

Monitor for hypotension when sildenafil is co-administered with amlodipine.

Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

Co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure.

Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine.

Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.

Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including valsartan.

When pregnancy is detected, discontinue Exforge as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Advise women not to breastfeed during treatment with Exforge.

GoToSource

• Use in patients under the age of 18. GoToSource

• Dosage greater than 10/320 mg once daily. GoToSource

Erythematous maculopapular eruption (flat or raised red bump on the skin). GoToSource

Worsening angina. GoToSource

Sprue-like enteropathy (intestinal condition involving chronic diarrhea, nausea, severe stomach discomfort rapid weight loss) and cholestasis (flow of bile from liver is reduced or blocked). GoToSource

Hyperkalemia (high potassium levels in blood). GoToSource 

Heart failure, pulmonary edema (excess fluid in lungs), flushing, dizziness, headache, drowsiness and skin rash. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Gout (form of inflammatory arthritis). GoToSource

Fetal toxicity. GoToSource

Hypotension (low blood pressure). GoToSource

Peripheral edema (swelling from fluid accumulation in body tissues). GoToSource

Lawsuits filed for cancer resulting from NDMA-tainted valsartan.