Valsartan
Dosing in kidney impairment
Renal Impairment Safety and effectiveness of valsartan in patients with severe renal impairment (glomerular filtration rate less than 30 mL/min/1.73 m 2 ) have not been established. No dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 mL/min/1.73 m 2 ) or moderate (glomerular filtration rate 30 to 60 mL/min/1.73 m 2 ) renal impairment.
Dosing in liver impairment
Hepatic Impairment No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.
Preparation and administration
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. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [see Clinical Pharmacology].
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 30ºC/86ºF) or up to 75 days at refrigerated conditions (2ºC to 8ºC/35ºF to 46ºF) 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. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information.