Exforge Generic Name & Formulations
Legal Class
Rx
General Description
Amlodipine (as besylate), valsartan; 5mg/160mg, 5mg/320mg, 10mg/160mg, 10mg/320mg; tabs.
Pharmacological Class
Calcium channel blocker (CCB) (dihydropyridine) + angiotensin II receptor blocker (ARB).
How Supplied
Tabs—30
Manufacturer
Generic Availability
YES
Exforge Indications
Indications
Hypertension.
Exforge Dosage and Administration
Adult
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.
Children
Not established.
Exforge Contraindications
Contraindications
Concomitant aliskiren in patients with diabetes.
Exforge Boxed Warnings
Boxed Warning
Fetal toxicity.
Exforge Warnings/Precautions
Warnings/Precautions
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: avoid. Nursing mothers: not recommended.
Exforge Pharmacokinetics
See Literature
Exforge Interactions
Interactions
See Contraindications. Concomitant renin-angiotensin system (RAS) inhibitors, K+ supplements, K+ sparing diuretics, K+-containing salt substitutes or other drugs (eg, heparin) may cause hyperkalemia and, in heart failure patients to increases in serum creatinine. 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 (eg, rifampicin, St. Johns wort). 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 RAS 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).
Exforge Adverse Reactions
Adverse Reactions
Peripheral edema, nasopharyngitis, upper respiratory infection, dizziness; rare: orthostatic hypotension, postural dizziness.
Exforge Clinical Trials
See Literature
Exforge Note
Not Applicable
Exforge Patient Counseling
See Literature
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