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TRIBENZOR
Hypertension
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Drug Name:

TRIBENZOR Rx

Generic Name and Formulations:
Olmesartan medoxomil, amlodipine (as besylate), hydrochlorothiazide; 20mg/5mg/12.5mg, 40mg/5mg/12.5mg, 40mg/5mg/25mg, 40mg/10mg/12.5mg, 40mg/10mg/25mg; tabs.

Company:
Daiichi Sankyo

Therapeutic Use:

Indications for TRIBENZOR:

Hypertension. Not for initial therapy.

Adult:

Individualize. 1 tab once daily. May titrate at 2-week intervals; max one 40/10/25mg tab daily. ≥75yrs or severe hepatic impairment: start amlodipine 2.5mg.

Children:

Not established.

Contraindications:

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

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Severe renal impairment (CrCl ≤30mL/min): avoid. Renal artery stenosis. Suspend if renal dysfunction progresses. Correct salt/volume depletion prior to starting therapy. Severe hepatic impairment. Severe CHF or obstructive coronary artery disease. Severe aortic stenosis. Diabetes. Postsympathectomy. SLE. Gout. Acute myopia and secondary angle-closure glaucoma. Monitor electrolytes. Neonates. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). Take 4hrs before colesevelam HCl dose. Concomitant simvastatin: max simvastatin dose 20mg/day. May potentiate cyclosporine, tacrolimus, lithium; monitor levels. Potentiated by CYP3A4 inhibitors; may need dose reduction. Adjust antidiabetic, antigout medications. ACTH, corticosteroids increase hypokalemia risk. Orthostatic hypotension potentiated by alcohol, barbiturates, narcotics. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors; monitor renal function in elderly and/or volume-depleted. Reduced absorption with bile acid resins (eg, cholestyramine, colestipol). Potentiates other antihypertensives. May potentiate nondepolarizing muscle relaxants. May antagonize norepinephrine. Monitor BP with CYP3A4 inducers. May interfere with parathyroid tests.

Pharmacological Class:

Angiotensin II receptor blocker (ARB) + dihydropyridine calcium channel blocker (CCB) + thiazide diuretic.

Adverse Reactions:

Dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, diarrhea, URI, UTI, joint swelling; hyperuricemia, orthostatic hypotension, electrolyte disturbances, possible sprue-like enteropathy.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

NO

How Supplied:

Tabs—30, 90

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