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Tribenzor

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Tribenzor

Tribenzor

INDICATIONS

Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Tribenzor.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

This fixed combination drug is not indicated for the initial therapy of hypertension [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

General Considerations

Dose once daily.

Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of Tribenzor is 40/10/25 mg. Tribenzor may be taken with or without food.

Tribenzor may be administered with other antihypertensive agents.

Renal Impairment

The usual regimens of therapy with Tribenzor may be followed if the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Tribenzor [see WARNINGS AND PRECAUTIONS].

Elderly

Patients ≥ 75 years of age should start amlodipine at 2.5 mg, which is not available with Tribenzor.

Hepatic Impairment

Patients with severe hepatic impairment should start amlodipine at 2.5 mg, which is not available with Tribenzor [see WARNINGS AND PRECAUTIONS].

Replacement Therapy

Tribenzor may be substituted for its individually titrated components.

Add-on/Switch Therapy

Tribenzor may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Tribenzor may be switched to Tribenzor containing a lower dose of that component to achieve similar blood pressure reductions.

HOW SUPPLIED

Dosage Forms And Strengths

Tribenzor tablets are formulated for oral administration in the following strength combinations: (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20 /5 /12.5 mg, 40 /5 / 12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg.

Storage And Handling

Tribenzor tablets contain olmesartan medoxomil, amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide in the strengths described below.

Tribenzor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Tribenzor tablets are supplied for oral administration in the following strength and package configurations:

Tablet Strength (OM/AML equivalent/HCTZ) Package Configuration NDC# Product Code Tablet Color
20 /5 /12.5 mg Bottle of 30 65597-114-30 C51 Orange white
Bottle of 90 65597-114-90
10 blisters of 10 65597-114-10
40 /5 /12.5 mg Bottle of 30 65597-115-30 C53 Light yellow
Bottle of 90 65597-115-90
10 blisters of 10 65597-115-10
40 /5 /25 mg Bottle of 30 65597-116-30 C54 Light yellow
Bottle of 90 65597-116-90
10 blisters of 10 65597-116-10
40 /10 /12.5 mg Bottle of 30 65597-117-30 C55 Grayish red
Bottle of 90 65597-117-90
10 blisters of 10 65597-117-10
40 /10 /25 mg Bottle of 30 65597-118-30 C57 Grayish red
Bottle of 90 65597-118-90
10 blisters of 10 65597-118-10

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Manufactured for Daiichi Sankyo, Inc., Parsippany, New Jersey 07054 Manufactured by Daiichi Sankyo Europe GmbH, Germany. Revised: July 2013

Last reviewed on RxList: 7/24/2013
This monograph has been modified to include the generic and brand name in many instances.

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