# Valsartan ```text DRUG INFORMATION ADULT - 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. Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 - Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day. Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 - 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. Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 CHILD - The antihypertensive effects of valsartan have been evaluated in 5 clinical studies in pediatric patients from 1 to 16 years of age [see Clinical Studies ( 14.1 )]. The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology ( 12.3 )]. The adverse experience profile of valsartan was similar to that described for adults [see Adverse Reactions ( 6.1 )]. Source: US FDA label for valsartan (Valsartan), section 'pediatric use', retrieved 2026-08-29 - 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. Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 - Valsartan tablets may be administered with other antihypertensive agents. 2.3 Pediatric Hypertension 1 to 16 Years of Age The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total). Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 RENAL IMPAIRMENT - No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m 2 [see Use in Specific Populations ( 8.4 )]. Source: US FDA label for valsartan (Valsartan), section 'dosage and administration', retrieved 2026-08-29 - Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 - No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min/1.73 m 2 . 8.5 Geriatric Use In the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 HEPATIC IMPAIRMENT - 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. 8.7 Hepatic Impairment No dose adjustment is necessary for patients with mild-to-moderate liver disease. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 - No dosing recommendations can be provided for patients with severe liver disease. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 PREGNANCY - Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Source: US FDA label for valsartan (Valsartan), section 'pregnancy', retrieved 2026-08-29 - 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. Source: US FDA label for valsartan (Valsartan), section 'pregnancy', retrieved 2026-08-29 - Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Source: US FDA label for valsartan (Valsartan), section 'pregnancy', retrieved 2026-08-29 BREASTFEEDING - Lactation : Breastfeeding is not recommended ( 8.2 ) Pediatrics : Use of valsartan is not recommended in children less than 1 year of age ( 6.1 , 8.4 , 13.2 ) 8.1 Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 - In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 - In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. 8.2 Lactation Risk Summary There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Source: US FDA label for valsartan (Valsartan), section 'use in specific populations', retrieved 2026-08-29 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)