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Diovan

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Diovan

Diovan

INDICATIONS

Hypertension

Diovan® (valsartan) 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 valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan.

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.

Diovan may be used alone or in combination with other antihypertensive agents.

Heart Failure

Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See Clinical Studies]

Post-Myocardial Infarction

In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [See Clinical Studies]

DOSAGE AND ADMINISTRATION

Adult Hypertension

The recommended starting dose of Diovan (valsartan) is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment.

Diovan may be administered with other antihypertensive agents.

Diovan may be administered with or without food.

Pediatric Hypertension 6-16 years of age

For children who can swallow capsules, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). (Doses below 80 mg are available only in the tablet form.) The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.

For children who cannot swallow capsules or tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of Diovan, the use of a suspension is recommended. The suspension preparation instructions are available based on the Diovan tablet form.

No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m² . [See Pediatric Use]

Diovan is not recommended for patients < 6 years old. [See ADVERSE REACTIONS, Clinical Studies]

Heart Failure

The recommended starting dose of Diovan is 40 mg twice daily. (Doses below 80 mg are available only in the tablet form.) Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.

Post-Myocardial Infarction

Diovan may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of Diovan is 20 mg twice daily. Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. (Doses below 80 mg are available only in the tablet form.) If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. Diovan may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins.

HOW SUPPLIED

Dosage Forms And Strengths

80 mg are light pink and light grey capsules, imprinted CG/FZF

160 mg are light pink and dark grey capsules, imprinted CG/GOG

Storage And Handling

Diovan (valsartan) is available as capsules containing valsartan 80 mg or 160 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 capsules) as described below.

Capsule Color Light pink and Imprint NDC
Bottle Blister
80 mg Light grey CG FZF 0083-4000-01 0083-4000-61
160 mg Dark grey CG GOG 0083-4001-01 0083-4001-61

Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Distributed by: Novartis Pharmaceuticals Corp. East Hanover, NJ 07936. Revised: October 2013.

Last reviewed on RxList: 11/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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