Usual Adult Dose for Congestive Heart Failure

Initial dose: 40 mg orally twice a day
Maintenance dose: 80 to 160 mg twice a day. The dose should be increased to the highest dose tolerated by the patient.

Usual Adult Dose for Hypertension

Initial dose: 80 to 160 mg orally once a day.
Maintenance dose: 80 to 320 mg orally once a day

Usual Adult Dose for Myocardial Infarction

Initial dose: 20 mg orally twice a day
Maintenance dose: The initial dosage may be titrated upward within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice a day as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.

Comment: Valsartan may be initiated as early as 12 hours after a myocardial infarction, and may be given with other standard postmyocardial infarction treatment, including thrombolytics, aspirin, beta blockers, and statins.

Usual Pediatric Dose for Hypertension

6 to 16 years:
Initial dose: 1.3 mg/kg once a day (up to 40 mg)
Maintenance dose: up to 2.7 mg/kg (up to 160 mg) once a day titrated according to patient response

Comments:

• If the calculated dosage does not correspond to the available tablet strengths, or if children are unable to swallow tablets, the use of a suspension (which can be prepared from the tablets) is recommended. The valsartan dose may need to be increased if the suspension is replaced by a tablet.
• No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min.

Renal Dose Adjustments

CrCl less than 30 mL/min: not recommended: Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.

Pediatric patients 6 to 16 years:
CrCl less than 30 mL/min: Not recommended

Comment:

• Pediatric patients with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.

Liver Dose Adjustments

Mild to moderate liver disease: No dosage adjustment recommended
Severe liver disease: Data unavailable

Dose Adjustments

Doses may be increased every 4 weeks up to 320 mg orally per day or a diuretic may be added. Adding a diuretic may be more effective than increasing the dose beyond 80 mg orally per day. Doses should be reduced in the presence of intravascular volume depletion.

Precautions

US BOXED WARNING:

• PREGNANCY: The 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. Adverse effects may include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, valsartan should be discontinued as soon as possible.

Dialysis

Valsartan is not removed by hemodialysis.

No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min/1.73 m2.

Other Comments

Administration advice:

• Valsartan should be taken consistently either with or without food.

• The maximal antihypertensive effects of valsartan are usually achieved 4 weeks after initiation of therapy.
• Compared with Caucasian patients, Black patients have a reduced blood pressure response to monotherapy with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers; however, the reduced response is largely eliminated if combination therapy that includes an adequate dose of a diuretic is instituted.

• Advice women not to breastfeed during treatment with this drug.
• Advise patients that lightheadedness can occur, especially during the first days of treatment, and that it should be reported to their healthcare provider.
• Advise patients to discontinue this drug until a physician has been consulted if syncope occurs.
• Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure.
• Advise patients not to use salt substitutes without first consulting their healthcare provider.

Frequently asked questions

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