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Amturnide

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Amturnide

Amturnide

INDICATIONS

Amturnide 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 amlodipine and hydrochlorothiazide. There are no controlled trials demonstrating risk reduction with Amturnide.

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 initial therapy of hypertension.

DOSAGE AND ADMINISTRATION

General Considerations

Dose once-daily. The dosage may be increased after 2 weeks of therapy. The maximum recommended dose of Amturnide is 300/10/25 mg.

Add-on/Switch Therapy

Use Amturnide for patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium channel blockers, and thiazide diuretics.

Switch a patient who experiences dose-limiting adverse reactions attributed to an individual component—while on any dual combination of the components of Amturnide—to Amturnide at a lower dose of that component to achieve similar blood pressure reductions.

Replacement Therapy

For patients receiving aliskiren, amlodipine and HCTZ from separate tablets, substitute Amturnide containing the same component doses.

Relationship to Meals

Patients should establish a routine pattern for taking Amturnide, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially [see CLINICAL PHARMACOLOGY].

Dosing in Specific Populations

Renal Impairment

The usual regimens of Amturnide may be followed as long as the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Amturnide is not recommended [see WARNINGS AND PRECAUTIONS].

Hepatic Impairment

In patients with severe hepatic impairment, start amlodipine at 2.5 mg per day, a dose that is not available in Amturnide [see WARNINGS AND PRECAUTIONS].

Elderly Patients

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

HOW SUPPLIED

Dosage Forms And Strengths

Tablets are convex ovaloid with a beveled edge, film-coated, and unscored, in the following strengths:

Aliskiren/Amlodipine/HCTZ (mg) Color Embossing Side 1/side 2
150/5/12.5 Violet white YIY/NVR
300/5/12.5 Light pink LIL/NVR
300/5/25 Pale orange brown OIO/NVR
300/10/12.5 Light red UIU/NVR
300/10/25 Brown VIV/NVR

Storage And Handling

Tablets are convex ovaloid with a beveled edge, film-coated, and unscored, in the following strengths and packages:

Aliskiren/ Amlodipine/ HCTZ (mg) Color Embossing Side 1/side 2 NDC 0078-XXXX-XX
Bottle/30 Bottle/90 Blister/100
150/5/12.5 Violet white YIY/NVR 0610-15 0610-34 0610-35
300/5/12.5 Light pink LIL/NVR 0611-15 0611-34 0611-35
300/5/25 Pale orange brown OIO/NVR 0612-15 0612-34 0612-35
300/10/12.5 Light red UIU/NVR 0613-15 0613-34 0613-35
300/10/25 Brown VIV/NVR 0614-15 0614-34 0614-35

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in original container.

Protect from heat and moisture.

Dispense in original container.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: 12/2011

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

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