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EXFORGE HCT
Hypertension
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Drug Name:

EXFORGE HCT Rx

Generic Name and Formulations:
Amlodipine (as besylate), valsartan, hydrochlorothiazide; 5mg/160mg/12.5mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg; tabs.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for EXFORGE HCT:

Hypertension. Not for initial therapy.

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.

Contraindications:

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

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 (monitor). Dialysis. Surgery. SLE. Diabetes. Gout. Acute myopia and secondary angle-closure glaucoma. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

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 inducer. 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. Lithium toxicity; monitor. Carbamazepine may lead to symptomatic hyponatremia. Cyclosporine may increase the risk of hyperuricemia and gout-type complications. 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. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Give at least 4hrs before or 4–6hrs after administration of ion exchange resins (eg, cholestyramine, colestipol). May interfere with parathyroid tests.

Pharmacological Class:

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

Adverse Reactions:

Dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, nasopharyngitis.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Tabs—30

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