valsartan

Absorption: 10–35% absorbed following oral administration. Systemic exposure 60% higher with the oral solution compared to tablets.

Distribution: Crosses the placenta.

Protein Binding: 95%.

Metabolism/Excretion: Minor metabolism by the liver; 13% excreted in urine; 83% in feces.

Half-Life: 6 hr.

Time/Action Profile ⬆ ⬇

(antihypertensive effect)

ROUTE	ONSET	PEAK	DURATION
PO	within 2 hr*	4 wk‡	24 hr‡

*After single dose.

‡Chronic dosing.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Volume- or salt-depleted patients or patients receiving large doses of diuretics (correct deficits before initiating therapy or initiate at lower doses);
Black patients (may not be as effective);
Impaired renal function due to primary renal disease or HF (may worsen renal function);
Severe renal impairment (CCr <30 mL/min);
Hepatic impairment;
Pedi: Children <1 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypotension

EENT: pharyngitis, rhinitis, sinusitis

F and E: hyperkalemia

GI: abdominal pain, diarrhea, nausea

GU: renal impairment

MS: arthralgia, back pain

Neuro: dizziness, fatigue, headache

Misc: ANGIOEDEMA

Interactions ⬆ ⬇

Drug-drug:

Additive hypotension with other antihypertensives.
Excessive hypotension may occur with concurrent use of diuretics.
↑risk of hyperkalemia with concurrent use of potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics.
↑risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/min; avoid concurrent use with ACE inhibitors.
NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.
May ↑ levels and risk of lithium toxicity.

Route/Dosage ⬆ ⬇

Oral tablets and solution are NOT interchangeable on a mg-per-mg basis. These dosage forms should not be combined to arrive at a particular dose.

Hypertension

PO (Adults ): 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume depleted; may be ↑ up to 320 mg once daily.
PO (Children 1–16 yr): 1 mg/kg once daily (maximum dose = 40 mg/day) (may consider using starting dose of 2 mg/kg once daily if greater BP reduction needed); may ↑ up to 4 mg/kg once daily (maximum dose = 160 mg/day).

Heart Failure

PO (Adults ): 40 mg twice daily; dose may be titrated up to target dose of 160 mg twice daily, as tolerated.

Post–Myocardial Infarction

PO (Adults ): 20 mg twice daily (may be initiated ≥ 12 hr after MI); dose may be titrated up to target dose of 160 mg twice daily, as tolerated.

Availability ⬆ ⬇

(Generic available)

Tablets: 40 mg; 80 mg; 160 mg; 320 mg
Oral solution grape flavor: 4 mg/mL
In combination with: amlodipine (Exforge), amlodipine/hydrochlorothiazide (Exforge HCT), and hydrochlorothiazide (Diovan HCT); see Appendix [not included in this PDA edition]).

Assessment ⬆ ⬇

Check BP initially and with dose adjustments at monthly intervals until control is achieved and then every 3–6 mo in patients who have met BP goals.
Assess patients for signs of angioedema (dyspnea, wheezing, facial or throat swelling, hoarseness); provide necessary emergency care. If angioedema occurs, discontinue valsartan.
HF: Monitor daily weight and assess patient routinely for resolution of fluid overload (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).

Lab Test Considerations:

Monitor renal function and electrolytes. May ↑ BUN, serum creatinine, and potassium.
- May cause hyperkalemia.
- May ↑ AST and ALT.
- May cause slight ↓ in hemoglobin and hematocrit, or neutropenia.

Implementation ⬆ ⬇

Do not confuse Diovan with Zyban.
Volume depletion should be corrected, if possible, before initiation of therapy.
Discontinuation of valsartan 24 hr prior to nonacute cardiac surgery is recommended due to ↑ risk for perioperative hypotension and vasodilatory shock, but switching to a short-acting ACE inhibitor or ARB can be considered in those with preoperative uncontrolled hypertension.
PO: May be taken without regard to food.
Oral tablets and solution are not interchangeable on a mg-per-mg basis. These dosage forms should not be combined to arrive at a particular dose. Store oral solution at room temperature.

Patient/Family Teaching ⬆ ⬇

Educate patient on reason for valsartan and side effects. Instruct them to take medication as directed at the same time each day, even if feeling well. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Warn patient not to discontinue therapy unless directed by health care professional. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See Food Sources for Specific Nutrients.
Caution patient to avoid sudden position changes to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to call 911 and immediately seek medical care notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs and cough, cold, or allergy medications, without consulting health care professional.
Instruct patient to notify health care professional of medication regimen before treatment or surgery.
Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
- Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.
Rep: May cause fetal harm. Valsartan should be discontinued as soon as possible when pregnancy is detected. Closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia; if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Advise patient to avoid breastfeeding during therapy.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇