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Valsartan

Medically reviewed by Drugs.com. Last updated on Jul 25, 2020.

Pronunciation

(val SAR tan)

Index Terms

  • Prexxartan

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Diovan: 40 mg [scored]

Diovan: 80 mg, 160 mg, 320 mg

Generic: 40 mg, 80 mg, 160 mg, 320 mg

Brand Names: U.S.

  • Diovan

Pharmacologic Category

  • Angiotensin II Receptor Blocker
  • Antihypertensive

Pharmacology

Valsartan produces direct antagonism of the angiotensin II (AT2) receptors, unlike the ACE inhibitors. It displaces angiotensin II from the AT1 receptor and produces its blood pressure-lowering effects by antagonizing AT1-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic responses. This action results in more efficient blockade of the cardiovascular effects of angiotensin II and fewer side effects than the ACE inhibitors.

Distribution

Vd: 17 L

Metabolism

To inactive metabolite (valeryl 4-hydroxy valsartan)

Excretion

Feces (83%) and urine (~13%) as unchanged drug

Clearance: Found to be similar per kg bodyweight in children vs adults receiving a single dose of the suspension (Blumer 2009)

Onset of Action

~2 hours

Time to Peak

Serum:

Children and Adolescents 1 to 16 years: Oral suspension: 2 hours (Blumer 2009)

Adults: Tablets: 2 to 4 hours; Oral solution: 0.7 to 3.7 hours (high-fat, high-calorie meal decreased Cmax ~44%)

Duration of Action

24 hours

Half-Life Elimination

Children 1 to 5 years: ~4 hours (Blumer 2009)

Children and Adolescents 6 to 16 years: ~5 hours (Blumer 2009)

Adults: ~6 hours; ~35% longer in elderly patients

Protein Binding

95%, primarily albumin

Special Populations: Hepatic Function Impairment

Patients with mild-to-moderate chronic liver disease have about twice the AUC value.

Special Populations: Elderly

AUC is about 70% higher and the half-life is 35% longer in elderly patients.

Use: Labeled Indications

Heart failure with reduced ejection fraction: Treatment of heart failure (NYHA class II to IV).

Hypertension: Management of hypertension.

Post–myocardial infarction: Reduction of cardiovascular mortality in patients with left ventricular dysfunction or failure following myocardial infarction (MI) (eg, acute coronary syndromes such as ST-elevation MI or non–ST-elevation MI).

Off Label Uses

Proteinuric chronic kidney disease (nondiabetic or diabetic)

Based on the 2012 Kidney Disease Improving Global Outcomes guideline for the evaluation and management of chronic kidney disease (CKD), the use of an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker is recommended in patients with proteinuric CKD to prevent progression of CKD [KDIGO 2013].

Contraindications

Hypersensitivity to valsartan or any component of the formulation; concomitant use with aliskiren in patients with diabetes mellitus.

Documentation of allergenic cross-reactivity for angiotensin II receptor blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with aliskiren in patients with moderate to severe renal impairment (GFR <60 mL/minute/1.73 m2); pregnancy; breastfeeding.

Dosing: Adult

Note: A commercial oral solution, Prexxartan, has been FDA-approved but is not currently available for patient use. Prexxartan oral solution and the oral suspension prepared from tablets have greater bioavailability than tablets. All doses shown in this monograph are for the oral tablets. When converting to an oral liquid preparation, reassess dose.

Acute coronary syndromes:

Note: Alternative in patients who cannot tolerate an angiotensin-converting enzyme (ACE) inhibitor (eg, due to cough) (ACC/AHA [Amsterdam 2014]; ACCF/AHA [O'Gara 2013]; Guyer 2020). In patients with prior ACE inhibitor–associated angioedema (ie, without urticaria or other signs of hypersensitivity), an angiotensin II receptor blocker (ARB) may still be an alternative. ARBs do not appear to elevate the risk of angioedema (Rasmussen 2019; Toh 2012); however, patients must be educated that angioedema due to an ACE inhibitor can sometimes reoccur within months following discontinuation (Beltrami 2011); referral to an allergist may be appropriate.

Non–ST-elevation acute coronary syndrome (alternative agent):

Note: Initiate in stable patients prior to hospital discharge as a component of an appropriate medical regimen, which may include antiplatelet agent(s), a beta-blocker, and a statin. Continue indefinitely for patients with concurrent diabetes, left ventricular ejection fraction ≤40%, hypertension, or stable chronic kidney disease (ACC/AHA [Amsterdam 2014]).

Oral: Initial: 20 mg twice daily; may increase dose as tolerated up to 160 mg twice daily under close monitoring to avoid hypotension.

ST-elevation myocardial infarction (alternative agent):

Note: In hemodynamically stable patients with large anterior ST-elevation myocardial infarction, consider starting within 24 hours of presentation as a component of an appropriate medical regimen, which may include antiplatelet agent(s), a beta-blocker, and a statin. Continue therapy indefinitely (ACCF/AHA [O'Gara 2013]).

Oral: Initial: 20 mg twice daily; may increase dose as tolerated up to 160 mg twice daily under close monitoring to avoid hypotension.

Heart failure with reduced ejection fraction (alternative agent):

Note: Alternative in patients who cannot tolerate an ACE inhibitor (eg, due to cough) (ACC/AHA/HFSA [Yancy 2017]; Guyer 2020). In patients with prior ACE inhibitor or angiotensin receptor-neprilysin inhibitor–associated angioedema (ie, without urticaria or other signs of hypersensitivity), an ARB may still be an alternative; consultation with a heart failure specialist and/or an allergist may be appropriate (Meyer 2020). ARBs do not appear to elevate the risk of angioedema (Rasmussen 2019; Toh 2012); however, patients must be educated that angioedema due to an ACE inhibitor can sometimes reoccur within months following discontinuation (Beltrami 2011).

Oral: Initial: 20 to 40 mg twice daily; increase dose, typically by doubling, every 1 to 2 weeks based on response and tolerability to a target dose of 160 mg twice daily (ACC/AHA/HFSA [Yancy 2017]; ACCF/AHA [Yancy 2013]; Meyer 2020). In closely monitored hospitalized patients, the dose may be titrated at 1- to 2-day intervals (Meyer 2020).

Hypertension:

Note: For patients who warrant combination therapy (BP >20/10 mm Hg above goal or suboptimal response to initial monotherapy), may use with another appropriate agent (eg, long-acting dihydropyridine calcium channel blocker or thiazide diuretic) (ACC/AHA [Whelton 2018]).

Oral: Initial: 80 to 160 mg once daily; evaluate response every 4 to 6 weeks and increase dose as needed up to a maximum of 320 mg once daily (ACC/AHA [Whelton 2018]; Mann 2020a). If the commercially produced oral solution is used, manufacturer labeling recommends administering the daily dose in 2 divided doses.

Proteinuric chronic kidney disease (nondiabetic or diabetic) (alternative agent) (off-label use):

Note: Dosing is based on dosing range in the manufacturer's labeling.

Oral: Initial: 40 to 80 mg twice daily depending on BP; can be titrated to 160 mg twice daily based on BP response and tolerability. Target an appropriate BP goal and proteinuria goal (eg, <1 g/day) (KDIGO 2013; Mann 2020b).

IgA nephropathy: In addition to an appropriate BP goal, a proteinuria goal of <1 g/day is also generally recommended (KDIGO 2013). Some experts treat to a proteinuria goal of <500 mg/day. If proteinuria goal is not met with monotherapy at the maximum tolerated dose, consider other treatment modalities and/or agents (Cattran 2020).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hypertension: Note: Oral dosage forms (tablets, solution [commercially available], and compounded suspension) are not bioequivalent on a mg:mg basis. Due to increased bioavailability of commercially available oral solution and extemporaneously prepared oral suspension, patients may require a higher dose when converting from oral suspension/solution to tablet dosage form. Consider lower listed initial dose in patients with hyponatremia, hypovolemia, severe CHF, decreased renal function, or in those receiving diuretics.

Infants 6 months to Children <6 years, weighing ≥6 kg and ≤40 kg: Limited data available; optimal dosage not defined: Oral: Extemporaneously compounded oral suspension was used in the trials (Flynn 2008; Schaefer 2013): Reported dosage range: 0.25 to 4 mg/kg/dose once daily. Dosing based on two multicenter, international, placebo-controlled, dose-response trials and open-label extensions (Flynn 2008; Schaefer 2013). In one trial, patients 6 months to <6 years weighing ≥6 kg and ≤40 kg, weight-directed initial doses of 0.25 mg/kg, 1 mg/kg, and 4 mg/kg once daily were used during the initial 6-week, placebo-controlled phase; significant reduction in SBP/DBP were observed; a dose-response trend was observed (greater BP reductions with medium and high doses) but statistical significance was not achieved and all doses were associated with statistically significant decreases in BP. In the open-label extension, doses were initiated at 1 mg/kg once daily and titrated at 2 weeks by doubling the dose to 2 mg/kg once daily and again at 4 weeks to 4 mg/kg once daily; maximum daily dose: 4 mg/kg/day or 160 mg/day, whichever is less; results from the extension were comparable to the initial dose-finding results (Schaefer 2013). Another trial of 90 children 1 to 5 years (mean age: 3.2 years; minimum patient weight: 8 kg) randomized patients to receive low, medium, or high doses according to patient body weight. Patients <18 kg received low dose: 5 mg once daily; medium dose: 20 mg once daily; or high dose: 40 mg once daily. Patients ≥18 kg received low dose: 10 mg once daily; medium dose: 40 mg once daily; or high dose: 80 mg once daily, resulting in a mean exposure dose of 0.4 to 3.4 mg/kg/day. Results showed significant antihypertensive effects in all dose level groups (Flynn 2008).

Children and Adolescents 6 to 16 years: Note: Obese pediatric patients 6 to 16 years were observed to respond at similar doses as nonobese (Meyers 2011):

Oral solution (commercially available): Initial: 0.65 mg/kg/dose twice daily; maximum initial daily dose: 40 mg/day; may titrate to effect up to a maximum dose: 1.35 mg/kg/dose twice daily; maximum daily dose: 160 mg/day

Tablets: Initial: 1.3 mg/kg once daily; maximum initial daily dose: 40 mg/day; may titrate to effect up to a maximum dose of 2.7 mg/kg/dose once daily or maximum daily dose: 160 mg/day (AAP [Flynn 2017]), whichever is lower; doses greater than this have not been studied

Adolescents ≥17 years:

Oral solution (commercially available): Initial: 40 or 80 mg twice daily; may titrate to effect up to a maximum daily dose: 320 mg/day

Tablets: Initial: 80 mg or 160 mg once daily; may titrate to effect up to a maximum daily dose: 320 mg/day

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Extemporaneously Prepared

A 4 mg/mL oral suspension may be made from tablets, Ora-Plus, and Ora-Sweet SF. Add 80 mL of Ora-Plus to an 8-ounce amber glass bottle containing eight valsartan 80 mg tablets. Shake well for ≥2 minutes. Allow the suspension to stand for a minimum of 1 hour, then shake for ≥1 minute. Add 80 mL of Ora-Sweet SF to the bottle and shake for ≥10 seconds. Store in amber glass prescription bottles; label "shake well". Stable for 30 days at room temperature, below 30°C (86°F), or 75 days refrigerated.

Diovan prescribing information, Novartis Pharmaceuticals Corp, East Hanover, NJ, 2017.

Administration

Oral:

Tablets: Administer with or without food.

Oral solution: Administer consistently with regard to food as high-fat meals decrease AUC ~8% and Cmax ~44%.

Dietary Considerations

Avoid salt substitutes which contain potassium.

Storage

Store tablets at 25°C (77°F) and solution at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Aliskiren: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the hypotensive effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Angiotensin II: Receptor Blockers may diminish the therapeutic effect of Angiotensin II. Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Angiotensin II Receptor Blockers may increase the serum concentration of Angiotensin-Converting Enzyme Inhibitors. Management: Use of telmisartan and ramipril is not recommended. It is not clear if any other combination of an ACE inhibitor and an ARB would be any safer. Consider alternatives when possible. Monitor blood pressure, renal function, and potassium if combined. Consider therapy modification

Antihepaciviral Combination Products: May increase the serum concentration of Valsartan. Management: Consider decreasing the valsartan dose and monitoring for evidence of hypotension and worsening renal function if these agents are used in combination. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Avoid combination

CycloSPORINE (Systemic): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of CycloSPORINE (Systemic). Monitor therapy

Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Drospirenone: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Drospirenone. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Gemfibrozil: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. See separate drug interaction monographs for agents listed as exceptions. Monitor therapy

Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

HydroCHLOROthiazide: May enhance the hypotensive effect of Valsartan. Valsartan may increase the serum concentration of HydroCHLOROthiazide. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy

Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium. Management: Initiate lithium at lower doses in patients receiving an angiotensin II receptor blocker (ARB). Consider lithium dose reductions in patients stable on lithium therapy who are initiating an ARB. Monitor lithium concentrations closely when combined. Consider therapy modification

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Angiotensin II Receptor Blockers. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Potassium Salts: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Ranolazine: May enhance the adverse/toxic effect of Angiotensin II Receptor Blockers. Monitor therapy

Sodium Phosphates: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with ARBs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Consider therapy modification

Tacrolimus (Systemic): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Tacrolimus (Systemic). Monitor therapy

Teriflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Monitor therapy

Tolvaptan: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Test Interactions

May lead to false-negative aldosterone/renin ratio (ARR) (Funder 2016)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Adverse reactions occurred with heart failure or post-MI unless otherwise indicated.

>10%:

Central nervous system: Dizziness (17%; hypertension: 2% to 8%)

Renal: Increased blood urea nitrogen (>50% increase: 17%)

1% to 10%:

Cardiovascular: Hypotension (6% to 7%; hypertension: <1%), orthostatic hypotension (2%), syncope (>1%; hypertension: <1%)

Central nervous system: Fatigue (2% to 3%), orthostatic dizziness (≤2%), headache (>1%), vertigo (>1%)

Endocrine & metabolic: Hyperkalemia (2%)

Gastrointestinal: Diarrhea (5%), abdominal pain (hypertension: 2%), nausea (>1%), upper abdominal pain (>1%)

Hematologic & oncologic: Neutropenia (2%)

Infection: Viral infection (hypertension: 3%)

Neuromuscular & skeletal: Arthralgia (3%), back pain (3%; hypertension: <1%)

Ophthalmic: Blurred vision (>1%)

Renal: Increased serum creatinine (≤4%), renal insufficiency (>1%)

Respiratory: Dry cough (hypertension: 3%)

<1%, postmarketing, and/or case reports: Alopecia, angioedema, anorexia, anxiety, asthenia, bullous dermatitis, chest pain, constipation, drowsiness, dyspepsia, dyspnea, flatulence, hepatitis, hypersensitivity reaction, impotence, increased liver enzymes, insomnia, muscle cramps, myalgia, palpitation, paresthesia, pruritus, renal failure syndrome, rhabdomyolysis, skin rash, thrombocytopenia, vasculitis, vomiting, xerostomia

ALERT: U.S. Boxed Warning

Fetal toxicity:

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue valsartan as soon as possible.

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angiotensin II receptor antagonists (ARBs) do not appear to elevate the risk of angioedema (Rasmussen 2019; Toh 2012). Patients with a history of angioedema due to an angiotensin-converting enzyme inhibitor must be educated that sometimes there can be recurrence within months following discontinuation (Beltrami 2011). No matter the cause of angioedema, prolonged frequent monitoring is required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. IM administration of epinephrine may be necessary. Do not readminister the ARB to patients who experience angioedema from this medication.

• Hyperkalemia: May occur; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts. Use with caution with these agents; monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with valsartan.

• Renal function deterioration: May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose GFR is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic/mitral stenosis: Use with caution in patients with significant aortic/mitral stenosis.

• Ascites: Avoid use in patients with ascites due to cirrhosis or refractory ascites; if use cannot be avoided in patients with ascites due to cirrhosis, monitor blood pressure and renal function carefully to avoid rapid development of renal failure (AASLD [Runyon 2012]).

• Heart failure: Use caution when initiating in heart failure; may need to adjust dose, and/or concurrent diuretic therapy, because of valsartan-induced hypotension. Careful monitoring of BUN, serum creatinine, and potassium is necessary especially if pre-existing renal disease exists.

• Hepatic impairment: Use with caution in patients with hepatic impairment (exposure to valsartan is increased).

• Renal artery stenosis: Use with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution in patients with renal impairment.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

• Solution: Commercially available oral solution is not therapeutically equivalent to the tablet formulation.

Special populations:

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic ARB therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (ACCF/AHA [Hillis 2011]). Based on current research and clinical guidelines in patients undergoing noncardiac surgery, continuing ARBs is reasonable in the perioperative period. If ARBs are held before surgery, it is reasonable to restart postoperatively as soon as clinically feasible (ACC/AHA [Fleisher 2014]).

Monitoring Parameters

Baseline and periodic BP, electrolyte panels, renal function.

Heart failure: Within 1 to 2 weeks after initiation, reassess BP (including postural blood pressure changes), renal function, and serum potassium; follow closely after dose changes. Patients with systolic BP <80 mm Hg, low serum sodium, diabetes mellitus, and impaired renal function should be closely monitored (ACC/AHA [Yancy 2013])

Hypertension: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2018]):

Confirmed hypertension and known CVD or 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥10%: Target BP <130/80 mm Hg is recommended.

Confirmed hypertension without markers of increased ASCVD risk: Target BP <130/80 mm Hg may be reasonable.

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines (ADA 2020):

Patients 18 to 65 years of age, without ASCVD, and 10-year ASCVD risk <15%: Target BP <140/90 mm Hg is recommended.

Patients 18 to 65 years of age and known ASCVD or 10-year ASCVD risk ≥15%: Target BP <130/80 mm Hg may be appropriate if it can be safely attained.

Patients >65 years of age (healthy or complex/intermediate health): Target BP <140/90 mm Hg is recommended.

Patients >65 years of age (very complex/poor health): Target BP <150/90 mm Hg is recommended.

Reproductive Considerations

The use of angiotensin II receptor blockers should generally be avoided in women planning a pregnancy (ACOG 203 2019).

Pregnancy Considerations

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue as soon as possible. The use of drugs that act on the renin-angiotensin system are associated with oligohydramnios. Oligohydramnios, due to decreased fetal renal function, may lead to fetal lung hypoplasia and skeletal malformations. Oligohydramnios may not appear until after irreversible fetal injury has occurred. Use in pregnancy is also associated with anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate. The exposed fetus should be monitored for fetal growth, amniotic fluid volume, and organ formation. Infants exposed in utero should be monitored for hyperkalemia, hypotension, and oliguria (exchange transfusions or dialysis may be needed). These adverse events are generally associated with maternal use in the second and third trimesters.

Chronic maternal hypertension may increase the risk of birth defects, low birth weight, preterm delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to duration and severity of maternal hypertension. Untreated hypertension may also increase the risk of adverse maternal outcomes, including gestational diabetes, myocardial infarction, preeclampsia, stroke, and delivery complications (ACOG 203 2019).

The use of angiotensin II receptor blockers is generally not recommended to treat chronic hypertension in pregnant women (ACOG 203 2019).

Patient Education

What is this drug used for?

• It is used to treat high blood pressure, heart failure (weak heart), and to help heart function after a heart attack. It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Abdominal pain

• Back pain

• Diarrhea

• Loss of strength and energy

• Joint pain

• Headache

• Flu-like symptoms

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain

• High potassium like abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling

• Severe dizziness

• Passing out

• Swelling of arms or legs

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions