Action

Blocks the vasoconstrictive and aldosterone-producing effects of angiotensin II at various receptor sites, including vascular smooth muscle and adrenal glands

Availability

Tablets: 40 mg, 80 mg, 160 mg, 320 mg

Indications and dosages

➣ Hypertension

Adults: Initially, 80 to 160 mg P.O. daily. May increase as needed to a maximum of 320 mg P.O. daily, or a diuretic may be added.

Children ages 6 to 16: Initially, 1.3 mg/kg (up to 40 mg total) P.O. once daily; dosage range is 1.3 to 2.7 mg/kg (40 to 160 mg total).

➣ Heart failure

Adults: 40 mg P.O. b.i.d., titrated to 80 mg or 160 mg P.O. b.i.d., as tolerated

➣ Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction

Adults: 20 mg P.O. b.i.d., followed by titration to 40 mg P.O. b.i.d., with subsequent titration to a target maintenance dosage of 160 mg P.O. b.i.d., as tolerated

Dosage adjustment

• Symptomatic hypotension

• Renal dysfunction

Off-label uses

• Left ventricular hypertrophy

• Diabetic nephropathy

Contraindications

• None

Precautions

Use cautiously in:

• severe heart failure; volume or sodium depletion; hepatic or renal impairment; obstructive biliary disorders; angioedema; aortic, mitral valve, or renal artery stenosis; hyperkalemia, hypotension

• pregnant or breastfeeding patients

• children younger than age 6 (safety not established).

Administration

• Give with or without food.

• For children who can't swallow tablets or children for whom calculated dosage doesn't correspond to available tablet strength, use a suspension but be aware that exposure to the suspension is 1.6 times greater than the tablet.

• To prepare 160 ml of a 4-mg/ml suspension, add 80 ml of Ora-Plus to bottle containing eight valsartan 80-mg tablets and shake for at least 2 minutes. Allow suspension to stand for at least 1 hour. Then shake for at least 1 additional minute. Add 80 ml of Ora-Sweet to bottle and shake for at least 10 seconds before giving appropriate dose. May store suspension for 30 days at room temperature or up to 75 days if refrigerated.

Be aware that drug isn't recommended for children with glomerular filtration rate of less than 30 ml/minute/1.73².

Adverse reactions

CNS: dizziness, fatigue, headache

CV: hypotension, palpitations

EENT: sinus disorders, rhinitis, pharyngitis

GI: nausea, diarrhea, constipation, abdominal pain, dry mouth

GU: albuminuria, renal impairment

Hematologic: neutropenia

Metabolic: hyperkalemia

Musculoskeletal: back pain, joint pain, muscle cramps

Respiratory: cough, upper respiratory tract infection

Skin: alopecia, angioedema

Other: dental pain, fever, viral infection, edema

Interactions

Drug-drug. Nonsteroidal anti-inflammatory drugs including selective cyclooxygenase-2 inhibitors: increased risk of renal impairment including acute renal failure in elderly patients, volume-depleted patients, or those with compromised renal function; loss of valsartan antihypertensive effect

Other antihypertensives: increased risk of hypotension

Potassium-sparing diuretics, potassium supplements: increased risk of hyperkalemia

Drug-diagnostic tests. Serum creatinine, serum and urine albumin, urine potassium: increased levels

Drug-food. Salt substitutes containing potassium: increased risk of hyperkalemia

Drug-herbs. Ephedra (ma huang): reduced hypotensive effect of valsartan

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor blood pressure closely, especially during initial therapy and dosage adjustments.

• Assess potassium level. Stay alert for hyperkalemia.

• Be aware that in black patients, drug may be ineffective when used alone. Additional agents may be required.

Patient teaching

• Tell patient he may take with or without food.

• For children who can't swallow tablets or children for whom calculated dosage doesn't correspond to available tablet strength, show caregiver how to prepare a suspension.

Instruct female of childbearing age to report pregnancy immediately.

• Advise breastfeeding patient to avoid breastfeeding while taking drug.

• Advise patient to avoid potassium-containing salt substitutes.

• Caution patient to avoid alcohol.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.