val-SAR-tan

Therapeutic Classification: antihypertensives

Pharmacologic Classification: angiotensin II receptor antagonists

• Alone or with other agents in the management of hypertension.
• Treatment of HF (New York Heart Association class II-IV).
• Reduction of risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

• Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites, including vascular smooth muscle and the adrenal glands.

• Lowering of BP in patients with hypertension.
• Decreased risk of HF-related hospitalizations in patients with heart failure.
• Decreased risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

Absorption: 10–35% absorbed following oral administration.

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.

(antihypertensive effect)

*After single dose.

†Chronic dosing.

Contraindicated in:

• Hypersensitivity
• Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min)
• OB: Pregnancy (may cause fetal harm)
• 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)
• Hepatic impairment
• Pedi: Children <6 yr (safety not established).

CV: edema, hypotension.

EENT: pharyngitis, rhinitis, sinusitis.

F and E: hyperkalemia.

GI: abdominal pain, diarrhea, nausea.

GU: impaired renal function.

MS: arthralgia, back pain.

Neuro: dizziness, fatigue, headache.
Misc: ANGIOEDEMA.

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 may ↑ the risk of lithium toxicity.

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 6–16 yr): 1.3 mg/kg once daily (maximum dose = 40 mg/day); may ↑ up to 2.7 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 hours after MI), dose may be titrated up to target dose of 160 mg twice daily, as tolerated.

(Generic available)

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

• Assess BP (lying, sitting, standing) and pulse frequently during initial dosage adjustment and periodically throughout therapy. Notify health care professional of significant changes.
• Monitor frequency of prescription refills to determine compliance.
• Assess patients for signs of angioedema (dyspnea, facial swelling).
• HF: Monitor daily weight and assess patient routinely for resolution of fluid overload (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).

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

• Do not confuse Diovan with Zyban (bupropion).
• Volume depletion should be corrected, if possible, before initiation of therapy.
• PO: May be taken without regard to food.

• Emphasize the importance of continuing to take as directed, at the same time each day, even if feeling well. Take missed doses as soon as remembered if not 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.
• Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See Appendix M.
• 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 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.
• Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
• May be teratogenic. Advise females of reproductive potential to use contraception and notify health care professional if pregnancy is planned or suspected, or if breastfeeding. 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.
• Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
• 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.

• Decrease in BP without appearance of excessive side effects. Effects are usually seen within 2 wks, with maximum effect in 4 wks.
• Decreased heart-failure-related hospitalizations in patients with HF.
• Decreased risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

Diovan

• Risk for injury (Adverse Reactions).
• Noncompliance (Patient/Family Teaching).