Valsartan (valsartan)

Dosage of valsartan must be individualized and adjusted according to blood pressure response. Substantial therapeutic response to valsartan generally occurs within 2 weeks of treatment initiation and maximal reduction is generally achieved after 4 weeks.

Valsartan is commercially available as tablets and a solution, administered orally. Although food may decrease the rate and extent (by about 40%) of valsartan absorption, the manufacturers state that the drug can be administered without regard to meals.

Valsartan is also commercially available in fixed-combination tablets containing valsartan and hydrochlorothiazide; valsartan and amlodipine; and valsartan, amlodipine, and hydrochlorothiazide; see the full prescribing information for administration of these combination products.

Store commercially available valsartan solution and tablets at 20degrees-25degreesC; excursions permitted between 15degrees-30degreesC. Protect from moisture.

Valsartan may be administered as an extemporaneously prepared oral suspension in pediatric patients 1--5 years of age, in patients >5 years of age who are unable to swallow tablets, or in pediatric patients for whom the calculated daily dosage does not correspond to the available tablet strengths. The tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dosage. The systemic exposure to valsartan is 60% higher with the suspension compared to tablets. When switching between dosage forms, the dosage of valsartan may need to be adjusted.

An extemporaneous suspension containing valsartan 4 mg/mL can be prepared in the following manner. First, add 80 mL of suspending vehicle (e.g., Ora-Plus(R)) to an amber glass bottle containing eight 80-mg tablets of valsartan, and shake the contents for at least 2 minutes. The concentrated suspension should be allowed to stand for at least 1 hour following reconstitution and then should be shaken for at least an additional minute. Dilute the concentrated valsartan suspension with 80 mL of sweetening vehicle (e.g., Ora-Sweet SF(R)), and shake for at least 10 seconds to disperse the contents. Shake bottle for at least 10 seconds before each dose is dispensed. When stored in an amber glass bottle with child-resistant screw-cap closure at a temperature of <30degreesC or at 2-8degreesC, the extemporaneous suspension is stable for up to 30 or up to 75 days, respectively.

Administer a missed dose as soon as possible unless it is almost time for the next dose. Do not double a dose to make up for a missed dose.

No dosing information is available for this tab.

No dosing information is available for this tab.

In vitro studies indicate that valsartan is minimally metabolized by cytochrome P-450 (CYP) 2C9.

In vitro studies indicate that valsartan does not inhibit CYP isoenzymes at therapeutic concentrations. Valsartan is a substrate of the hepatic uptake transporter organic anion transporting polypeptide (OATP) 1B1 and the hepatic efflux transporter multidrug resistance-associated protein 2 (MRP2).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to valsartan or any ingredient in the formulation.

*Concomitant use of valsartan and aliskiren in patients with diabetes mellitus.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring patients with hypertension receiving valsartan include headache, dizziness, viral infection, fatigue, and abdominal pain.

Adverse effects occurring in patients with heart failure receiving valsartan include dizziness, hypotension, diarrhea, arthralgia, fatigue, back pain, and hyperkalemia.

In patients receiving valsartan following acute MI, the most common adverse effects resulting in discontinuance of the drug included hypotension, cough, and increased blood creatinine.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of valsartan tablets have been established in a randomized, double-blind clinical trial in pediatric patients 1-16 years of age with hypertension; adverse effects of the drug in this age group were similar to those observed in adults. In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.

Valsartan tablet use is not recommended in children less than 1 year of age. Valsartan oral solution is not recommended in children less than 6 years of age. It is not known whether postnatal use of valsartan, before maturation of renal function is complete, has a long-term deleterious effect on the kidney.

Safety and efficacy of valsartan in pediatric patients with a glomerular filtration rate less than 30 mL/minute per 1.73 m2 have not been established.

Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios in pregnant women who use drugs affecting the RAS in the second or third trimester of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), hypotension, and death.

Valsartan should be discontinued as soon as possible when pregnancy is detected. In the unusual case that there is no appropriate alternative to therapy, apprise the mother of the potential risk to the fetus. If valsartan is taken during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate. Discontinue valsartan if oligohydramnios is detected; however, this may not appear until after the fetus has sustained irreversible injury.

Valsartan is distributed into milk in rats. It is not known whether valsartan is distributed into human milk or its effects on the breast-fed infant or milk production.

Advise nursing women that breast-feeding is not recommended while taking valsartan due to the potential for adverse reactions in the breast-fed infant.

The manufacturer states that no dosage adjustment is necessary in geriatric patients.

In the controlled clinical trials of valsartan, 1214 (36.2%) hypertensive patients treated with valsartan were >=65 years of age and 265 (7.9%) were >=75 years of age. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Exposure (measured by AUC) to valsartan is higher by 70% in geriatric patients than in younger patients; however, no dosage adjustment is necessary.

Of the 2511 patients with heart failure randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1141 patients) were 65 years of age or older. In the VALsartan In Acute myocardial iNfarcTion trial (VALIANT), 53% (2596) of the 4909 patients treated with valsartan and 51% (2515) of the 4885 patients treated with valsartan plus captopril were 65 years of age or older. There were no notable differences in efficacy or safety between older and younger patients in either trial. No substantial differences in safety and efficacy of valsartan in geriatric patients relative to younger adults have been observed, but increased sensitivity cannot be ruled out.