Exforge Hct

— THERAPEUTIC CATEGORIES —
  • Hypertension

Exforge Hct Generic Name & Formulations

General Description

Amlodipine (as besylate), valsartan, hydrochlorothiazide; 5mg/160mg/12.5mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg; tabs.

Pharmacological Class

Calcium channel blocker (CCB) (dihydropyridine) + angiotensin II receptor blocker (ARB) + thiazide diuretic.

How Supplied

Tabs—30

Generic Availability

YES

Exforge Hct Indications

Indications

Hypertension. Not for initial therapy.

Exforge Hct Dosage and Administration

Adult

One tab daily. Titrate at 2-week intervals; max one 10mg/320mg/25mg tab daily. Replacement therapy: may be substituted for individually titrated components. Add-on/switch therapy: may be used to provide additional BP lowering for patients not adequately controlled on doses of any two antihypertensive classes: ARBs, calcium channel blockers, and diuretics.

Children

Not established.

Exforge Hct Contraindications

Contraindications

Anuria. Sulfonamide allergy. Concomitant aliskiren in patients with diabetes.

Exforge Hct Boxed Warnings

Boxed Warning

Fetal toxicity.

Exforge Hct Warnings/Precautions

Warnings/Precautions

Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion, hypokalemia, hypomagnesemia prior to initiation. Heart failure. Recent MI. Severe obstructive coronary disease. Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy: not recommended. Monitor renal function in renal artery stenosis, CKD, severe CHF, or volume depletion. Monitor for hyperkalemia in renal insufficiency. Hepatic or severe renal impairment. Dialysis. Surgery. SLE. Diabetes. Gout. Acute myopia and secondary angle-closure glaucoma. Elderly. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.

Exforge Hct Pharmacokinetics

See Literature

Exforge Hct 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). Adjust antidiabetic, antigout medications. May increase lithium levels; monitor. Carbamazepine may lead to symptomatic hyponatremia. Cyclosporine may increase the risk of hyperuricemia and gout-type complications. 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. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). Give at least 4hrs before or 4–6hrs after administration of ion exchange resins (eg, cholestyramine, colestipol). May interfere with parathyroid tests.

Exforge Hct Adverse Reactions

Adverse Reactions

Dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, nasopharyngitis; HCTZ: increased risk for non-melanoma skin cancer.

Exforge Hct Clinical Trials

See Literature

Exforge Hct Note

Not Applicable

Exforge Hct Patient Counseling

See Literature