Valsartan

1 Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. 3) ] . Use of the oral suspension is recommended: in patients ≥ 6 years of age who cannot swallow tablets and in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan tablets When switching between suspension and tablets, the dose of valsartan may need to be adjusted.

Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour.

After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2°C to 8°C/35°F to 46°F) in the glass bottle with a child-resistant screw-cap closure.

Shake the bottle well (at least 10 seconds) prior to dispensing the suspension *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets.

2 Adult Hypertension The recommended starting dose of valsartan tablets 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.

Valsartan tablets 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. Valsartan tablets may be administered with other antihypertensive agents. 3 Pediatric Hypertension 6 to 16 Years of Age The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total).

gov/medwatch. 1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Hypertension Valsartan tablets have been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

The overall incidence of adverse reactions with valsartan tablets was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. 0% of placebo patients. The most common reasons for discontinuation of therapy with valsartan tablets were headache and dizziness.

The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan tablets and at a higher incidence in valsartan (n = 2,316) than placebo (n = 888) patients included viral infection (3% vs.

2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%). 5%). 001). Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with valsartan tablets 320 mg (8%) compared to 10 to 160 mg (2% to 4%).

Pediatric Hypertension Valsartan tablets have been evaluated for safety in over 400 patients aged 6 to 17 years. No relevant differences were identified between the adverse experience profile for pediatric patients and that previously reported for adult patients.

Hyperkalemia was more frequently observed in pediatric patients with underlying chronic kidney disease (CKD). Heart Failure In the Valsartan Heart Failure Trial (Val-HeFT), comparing valsartan in total daily doses up to 320 mg (n = 2,506) to placebo (n = 2,494), 10% of valsartan patients discontinued for adverse reactions vs.

1 Fetal Toxicity Valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. 1) ] . 1%) in patients with uncomplicated hypertension treated with valsartan tablets alone.

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan tablets, or the treatment should start under close medical supervision.

Patients with heart failure or post-myocardial infarction patients given valsartan tablets commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed.

8% in placebo-treated patients. 8% of captopril-treated patients. If excessive hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. , patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan tablets.

4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. 3) ]. Known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes ( 4 )