Generic Name and Formulations:
Amlodipine (as besylate), valsartan; 5mg/160mg, 5mg/320mg, 10mg/160mg, 10mg/320mg; tabs.
Novartis Pharmaceuticals Corp
Indications for EXFORGE:
Take once daily. Initial therapy and not volume depleted: Initially 5/160mg; may increase after 1–2 weeks up to max 10/320mg. Add-on therapy: may be used if not controlled on monotherapy; if inadequate response after 3–4 weeks, may titrate up to max 10/320mg. Replacement therapy: may be substituted for the titrated components. Maximum effects within 2 weeks after dose change. Elderly, hepatic impairment: initial therapy not recommended.
Concomitant aliskiren in patients with diabetes.
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion prior to initiation (may need to reduce diuretic) or monitor closely for hypotension. Heart failure. Recent MI. Severe aortic stenosis. Severe obstructive coronary disease. Monitor renal function in renal artery stenosis, CKD, severe CHF, or volume depletion. Monitor for hyperkalemia in renal insufficiency. Hepatic or severe renal impairment (monitor). Dialysis. Surgery. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.
See Contraindications. Concomitant K+ supplements, K+ sparing diuretics, K+ containing salt substitutes may lead to hyperkalemia; increased serum creatinine in HF. Potentiates simvastatin (limit simvastatin dose to 20mg daily), cyclosporine, or tacrolimus (monitor levels). May be potentiated by CYP3A4 inhibitors. Monitor BP if coadministered with CYP3A4 inducers. Monitor for hypotension with concomitant sildenafil. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). May be potentiated by inhibitors of OATP1B1 (eg, rifampin, cyclosporine) or MRP2 (eg, ritonavir). Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely; in general, avoid combined use of RAS inhibitors. May increase lithium levels; monitor. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min).
Calcium channel blocker (CCB) (dihydropyridine) + angiotensin II receptor blocker (ARB).
Peripheral edema, nasopharyngitis, upper respiratory infection, dizziness; rare: orthostatic hypotension, postural dizziness.
Hepatic; >93% protein bound.