Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: N-(1-Oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl)]-l-valine
Molecular Formula: C24H29N5O3
CAS Number: 137862-53-4
Brands: Diovan, Diovan HCT, Exforge (combination)
May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 37 114 115 116 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue as soon as possible.1 37 115 116
Introduction
Valsartan is an angiotensin II type 1 (AT1) receptor antagonist.1 2 3 4 5 6 7 8 9 10 19 37 116
Uses for Valsartan
Hypertension
Valsartan is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);1 2 3 4 5 6 8 9 19 37 68 116 may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.37 116
Angiotensin II receptor antagonists are one of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.68
Angiotensin II receptor antagonists can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.68
CHF
Angiotensin II receptor antagonists are second-line agents in the treatment of CHF; should be used only in those intolerant of ACE inhibitors.1 110 111
No additional therapeutic benefit when used as combination therapy with an ACE inhibitor.1
Heart Failure or Left Ventricular Dysfunction after Acute MI
Valsartan is used to reduce the risk of cardiovascular mortality in clinically stable patients who have demonstrated clinical signs of CHF or left ventricular dysfunction following MI.1 110 111
Most experts state that angiotensin II receptor antagonists should be used only in those intolerant of ACE inhibitors.50 110 111
Valsartan may be given with other standard post-MI therapy (e.g., thrombolytics, aspirin, β-adrenergic blocking agents, hydroxymethylglutaryl-CoA [HMG-CoA] reductase inhibitors [statins]).1
Diabetic Nephropathy
Angiotensin II receptor antagonists or ACE inhibitors are first-line agents in the treatment of diabetic nephropathy† in patients with type 2 diabetes mellitus and hypertension.
Valsartan Dosage and Administration
General
Hypertension
Fixed-combination valsartan/hydrochlorothiazide tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.37 Consider potential benefits and risks of initiating therapy with the fixed combination of valsartan and hydrochlorothiazide.37 Not recommended as initial therapy in patients who are volume depleted.37
If the patient’s baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 41, 50, or 84% and of achieving DBP control (DBP <90 mm Hg) is 60, 57, or 80% with valsartan (320 mg daily) alone, hydrochlorothiazide (25 mg daily) alone, or valsartan combined with hydrochlorothiazide (at same dosages), respectively.37
Fixed-combination valsartan/amlodipine tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.116 Consider potential benefits and risks of initiating therapy with the fixed combination of valsartan and amlodipine, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs.116
If the patient’s baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 47, 67, or 80% and of achieving DBP control (DBP <90 mm Hg) is 62, 80, or 85% with valsartan (320 mg daily) alone, amlodipine (10 mg daily) alone, or valsartan combined with amlodipine (at same dosages), respectively.116
CHF
Concomitant use of angiotensin II receptor antagonists (e.g., valsartan) with ACE inhibitors and β-adrenergic blocking agents not recommended (increased heart failure morbidity observed in clinical trial).1 50
Administration
Oral Administration
Administer valsartan orally once or twice daily without regard to meals.1 9 37
Administer valsartan as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets or in those for whom the calculated daily dosage does not correspond to the available tablet strengths.1
Reconstitution
Preparation of extemporaneous suspension containing valsartan 4 mg/mL: Add 80 mL of suspending vehicle (e.g., Ora-Plus) to an amber glass bottle containing 8 valsartan 80-mg tablets; shake the contents for ≥2 minutes.1 Allow concentrated suspension to stand for ≥1 hour, then shake for ≥1 additional minute.1 Dilute the concentrated suspension with 80 mL of sweetening vehicle (e.g., Ora-Sweet SF); shake the contents for ≥10 seconds.1 Shake suspension for ≥10 seconds before dispensing each dose.1
Dosage
Pediatric Patients
Hypertension
Valsartan Therapy for Hypertension
Oral
Children 6–16 years of age: Initially, valsartan 1.3 mg/kg (up to 40 mg) once daily.1 Adjust dosage according to patient response.1 Dosages >2.7 mg/kg (up to 160 mg) once daily have not been studied in children.1
May need to increase dosage when converting from extemporaneously prepared suspension to oral tablet, since exposure to valsartan with the suspension is 1.6 times greater than with the tablet.1
Adults
Hypertension
Valsartan Therapy for Hypertension
Oral
Initially, valsartan 80 or 160 mg once daily in adults without intravascular volume depletion.1 37 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.68
Usual valsartan dosage: 80–320 mg given once daily.1 19 However, at dosages >80 mg daily, addition of diuretic produces greater BP reduction than increases in valsartan dosage.1
Valsartan/Amlodipine Fixed-combination Therapy for Hypertension
Oral
In studies using valsartan/amlodipine fixed combination in dosages of valsartan 160–320 mg daily and amlodipine 5–10 mg daily, BP response increased with increasing dosages of the drugs.116
If BP is not adequately controlled by monotherapy with valsartan (or another angiotensin II receptor antagonist) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to the fixed-combination preparation containing valsartan 160 mg and amlodipine 5 or 10 mg or, alternatively, valsartan 320 mg and amlodipine 5 or 10 mg.116
If dose-limiting adverse effects have developed during monotherapy with valsartan or amlodipine, can switch to a fixed combination containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient’s response after 3–4 weeks of therapy.116
If BP is controlled with valsartan and amlodipine (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.116
When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is valsartan 160 mg and amlodipine 5 mg daily in those who are not volume depleted.116
Increase to maximum dosage of valsartan 320 mg and amlodipine 10 mg daily, if needed, to control BP.116 May adjust dosage at intervals of 1–2 weeks, since most of the antihypertensive effect of a given dosage is achieved within 2 weeks after a change in dosage.116
Valsartan/Hydrochlorothiazide Fixed-combination Therapy for Hypertension
Oral
If BP is not adequately controlled by monotherapy with valsartan (or another angiotensin II receptor antagonist) or hydrochlorothiazide, can switch to fixed-combination tablets containing valsartan 160 mg and hydrochlorothiazide 12.5 mg once daily.37
If dose-limiting adverse effects have developed during monotherapy with valsartan or hydrochlorothiazide, can switch to a fixed combination containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient’s response after 3–4 weeks of therapy.37
If BP is controlled with valsartan and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.37
When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is valsartan 160 mg and hydrochlorothiazide 12.5 mg daily in those who are not volume depleted.37 Adjust dosage according to patient’s response after 1–2 weeks of therapy.37
Increase to maximum dosage of valsartan 320 mg and hydrochlorothiazide 25 mg daily, if needed, to control BP.37 Maximum antihypertensive effect of a given dosage is achieved within 2–4 weeks after a change in dosage.37
CHF
Oral
Initially, valsartan 40 mg twice daily.1 Increase dosage to 160 mg twice daily (maximum dosage used in clinical trials) or highest tolerated dosage.1 (See Hypotension under Cautions.)
Heart Failure or Left Ventricular Dysfunction after Acute MI
Oral
Manufacturer states that valsartan therapy may be initiated ≥12 hours post-MI with a dosage of 20 mg twice daily.1 May increase dosage to 40 mg twice daily within 7 days, with subsequent titration to a target maintenance dosage of 160 mg twice daily, as tolerated.1
Consider dosage reduction if symptomatic hypotension or renal dysfunction occurs.1
Special Populations
The following information addresses dosage of valsartan in special populations. Dosages of drugs administered in fixed combination with valsartan also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.37 116
Hepatic Impairment
No adjustment of initial valsartan dosage necessary in patients with mild to moderate hepatic impairment.1 116 Cautious dosing recommended in patients with hepatic impairment; titrate dosage slowly.1 37 116
Amount of amlodipine in valsartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.116
Renal Impairment
No adjustment of initial valsartan dosage necessary in patients with mild to moderate renal impairment.1 37 116 Cautious dosing recommended in adults with severe impairment; titrate dosage slowly.1 116 Use of valsartan in pediatric patients with GFR <30 mL/minute per 1.73 m2 not recommended.1
Valsartan/hydrochlorothiazide fixed combination is not recommended in patients with Clcr≤30 mL/minute.37 Loop diuretics are preferred to thiazides in these patients.37
Geriatric Patients
No adjustment of initial valsartan dosage is necessary.1 37 116
Amount of amlodipine in valsartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients ≥75 years of age.116
Volume- and/or Salt-Depleted Patients
Correct volume and/or salt depletion prior to initiation of valsartan therapy or initiate therapy under close medical supervision.1 37 116
Cautions for Valsartan
Contraindications
Known hypersensitivity to valsartan or any ingredient in the formulation.37
When valsartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider contraindications associated with the concomitant agent.37 116
Warnings/Precautions
Warnings
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when drugs that act directly on the renin-angiotensin system (e.g., angiotensin II receptor antagonists, ACE inhibitors) are used during the second and third trimesters of pregnancy.1 16 17 19 20 21 22 23 24 25 26 27 28 29 31 32 33 34 35 36 37 116 (See Boxed Warning.) ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.114 115
Discontinue valsartan as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 37 114 115 116 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.17 25
Hypotension
Possible symptomatic hypotension with valsartan, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics).1 37 116 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)
Transient hypotension is not a contraindication to additional doses; may reinstate valsartan therapy cautiously after BP is stabilized (e.g., with volume expansion).1 37 116
Initiate valsartan therapy and subsequent dosage adjustments under close medical supervision in patients with CHF;1 consider reducing diuretic dosage.1
Malignancies
In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126
Sensitivity Reactions
Anaphylactoid reactions and/or angioedema possible with angiotensin II receptor antagonists;1 37 116 118 extreme caution in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.117 119
General Precautions
Use of Fixed Combinations
When valsartan is used in fixed combination with amlodipine or hydrochlorothiazide, consider the cautions, precautions, contraindications, and interactions associated with the concomitant agent.37 116 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.37 116
Renal Effects
Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.1 37 116
Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 37 116
Hyperkalemia
Hyperkalemia may occur, especially in patients with heart failure and preexisting renal impairment.1 116
Specific Populations
Pregnancy
Valsartan: Category D.1 37 116 (See Boxed Warning.)
Lactation
Valsartan is distributed into milk in rats; not known whether valsartan is distributed into human milk.1 37 116 Discontinue nursing or the drug.1 37 116
Pediatric Use
Safety and efficacy of valsartan in pediatric patients 6–16 years of age with hypertension established in a controlled clinical trial.1 Some evidence of efficacy in a controlled clinical trial in pediatric patients 1–5 years of age; however, 2 deaths and 3 cases of transaminase elevations were observed in an open-label extension study in this age group.1 Although causal relationship to valsartan has not been established, use is not recommended in pediatric patients <6 years of age.1
Safety and efficacy of valsartan not established in children with GFR <30 mL/minute per 1.73 m2.1
Safety and efficacy of valsartan in fixed combination with amlodipine or hydrochlorothiazide not established in children.37 116
Geriatric Use
No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity to valsartan alone or in fixed combination with amlodipine or hydrochlorothiazide cannot be ruled out.1 37 116
Hepatic Impairment
Systemic exposure to valsartan may be increased (see Absorption: Special Populations, under Pharmacokinetics).1 37 116 Use with caution.1 37 116
Renal Impairment
Valsartan not studied in patients with Clcr <10 mL/minute; use with caution in adults with severe renal impairment.1 18 37 116 Valsartan not studied in children with GFR <30 mL/minute per 1.73 m2; use not recommended.1
Deterioration of renal function may occur.1 37 116 (See Renal Effects under Cautions.)
Use of valsartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr ≤30 mL/minute.37
Blacks
BP reduction with angiotensin II receptor antagonists may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.1 37 68
Common Adverse Effects
Valsartan: Viral infection,1 fatigue,1 abdominal pain;1 also, dizziness,1 hypotension,1 postural dizziness or hypotension,1 hyperkalemia,1 arthralgia,1 diarrhea,1 and back pain in patients with CHF.1
Interactions for Valsartan
The following information addresses potential interactions with valsartan. When valsartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider interactions associated with the concomitant agent.37 116
Valsartan is metabolized in the liver, but the precise enzymes responsible are unknown but not believed to involve CYP enzymes.1 37 116 Not known whether valsartan induces or inhibits CYP enzymes.1 37 116
In vitro data suggest that valsartan is a substrate of organic anion transporter protein (OATP) 1B1 (hepatic uptake transporter) and multidrug resistance protein MRP2 (hepatic efflux transporter).1
Drugs That Inhibit Hepatic Transport Systems
Inhibitors of OATP 1B1 or MRP2: Possible increased systemic exposure to valsartan.1
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Amlodipine | Pharmacokinetic interaction unlikely1 37 116 | |
Atenolol | Pharmacokinetic interaction unlikely1 37 116 Additive antihypertensive effect; heart rate unaffected1 37 116 | |
Cimetidine | Pharmacokinetic interaction unlikely1 37 116 | |
Cyclosporine | Possible increased systemic exposure to valsartan1 | |
Digoxin | Pharmacokinetic interactions unlikely1 37 116 | |
Diuretic, potassium-sparing (e.g., amiloride, spironolactone, triamterene) | Possible additive hyperkalemic effects;1 37 116 possible increase in Scr in patients with CHF1 116 | |
Furosemide | Pharmacokinetic interactions unlikely1 37 116 | |
Glyburide | Pharmacokinetic interactions unlikely1 37 116 | |
Hydrochlorothiazide | Pharmacokinetic interactions unlikely1 37 116 Additive hypotensive effects1 37 | |
Indomethacin | Pharmacokinetic interactions unlikely1 37 116 | |
NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors | Possible deterioration of renal function in geriatric, volume-depleted, or renally impaired patients1 Possible reduced antihypertensive effects1 | Monitor renal function periodically1 |
Potassium supplements and potassium-containing salt substitutes | Possible additive hyperkalemic effect;1 37 116 possible increase in Scr in patients with CHF1 116 | |
Rifampin | Possible increased systemic exposure to valsartan1 | |
Ritonavir | Possible increased systemic exposure to valsartan1 | |
Warfarin | Pharmacokinetic interactions unlikely; INR unaffected1 37 116 |
Valsartan Pharmacokinetics
Absorption
Bioavailability
Absolute bioavailability of valsartan tablets is about 25% (range: 10–35%).1 37 116 Bioavailability of extemporaneously prepared suspension (see Reconstitution under Dosage and Administration) is 1.6 times greater than that of the tablets.1
Peak plasma concentration of valsartan reached about 2–4 hours following oral administration.1 37 116
Onset
Antihypertensive effect of valsartan evident within 2 weeks, with maximum BP reduction after 4 weeks.1 37
Food
Food may decrease rate and extent (e.g., AUC decreased by about 40%) of absorption of valsartan.1 9 37 116
Special Populations
In patients with mild to moderate chronic liver disease, systemic exposure to valsartan is doubled.1 37 116
Distribution
Extent
Valsartan crosses the placenta and is distributed in the fetus in animals.1 37
Valsartan is distributed into milk in rats; not known whether valsartan is distributed into human milk.1 37 116
Plasma Protein Binding
Valsartan: 95% (mainly albumin).1 37 116
Elimination
Metabolism
Valsartan is metabolized in the liver, but the precise enzymes responsible are unknown.1 37 116 CYP enzymes do not appear to play a role.1 37 116
Elimination Route
Valsartan is eliminated mainly as unchanged drug in feces (83%) and urine (13%).1 37 116
Half-life
Biexponential; average half-life of valsartan is approximately 6 hours following IV administration.1 37 116
Valsartan clearance is similar in adults and children.1
Special Populations
Valsartan is not removed by hemodialysis.1 37 116
Stability
Storage
Oral
Extemporaneous Suspension
Valsartan 4 mg/mL in Ora-Sweet SE and Ora-Plus (see Reconstitution under Dosage and Administration), stored in amber glass bottle with child-resistant screw-cap closure: Up to 30 days at <30ºC or up to 75 days at 2–8ºC.1
Tablets
Valsartan, valsartan/amlodipine or valsartan/hydrochlorothiazide fixed combination: Tight container at 25°C (may be exposed to 15–30°C).1 37 116 Protect from moisture.1 37 116
Actions
Valsartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 6 10 37 116
Valsartan does not interfere with response to bradykinins and substance P.1 4 6 10 37 116
Valsartan does not share the ACE inhibitor common adverse effect of dry cough.1 4 6 10
Advice to Patients
When valsartan is used in fixed combination with hydrochlorothiazide or amlodipine, importance of advising patients of important precautionary information about the concomitant agent.37 116
Risks of use during pregnancy.1 37 114 115 116
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 37 116
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1 37 116
Importance of contacting clinician if dizziness or faintness develops or if unexplained weight gain or swelling of the feet, ankles, or hands occurs.1 37 116
Importance of informing patients of other important precautionary information.1 37 116 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 40 mg | Diovan (scored) | Novartis |
80 mg | Diovan | Novartis | ||
160 mg | Diovan | Novartis | ||
320 mg | Diovan | Novartis |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 80 mg with Hydrochlorothiazide 12.5 mg | Diovan HCT | Novartis |
160 mg with Hydrochlorothiazide 12.5 mg | Diovan HCT | Novartis | ||
160 mg with Hydrochlorothiazide 25 mg | Diovan HCT | Novartis | ||
320 mg with Hydrochlorothiazide 12.5 mg | Diovan HCT | Novartis | ||
320 mg with Hydrochlorothiazide 25 mg | Diovan HCT | Novartis | ||
Tablets, film-coated | 160 mg with Amlodipine Besylate 5 mg (of amlodipine) | Exforge | Novartis | |
160 mg with Amlodipine Besylate 10 mg (of amlodipine) | Exforge | Novartis | ||
320 mg with Amlodipine Besylate 5 mg (of amlodipine) | Exforge | Novartis | ||
320 mg with Amlodipine Besylate 10 mg (of amlodipine) | Exforge | Novartis |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Diovan 160MG Tablets (NOVARTIS): 30/$104.00 or 90/$286.96
Diovan 320MG Tablets (NOVARTIS): 30/$130.99 or 90/$386.95
Diovan 40MG Tablets (NOVARTIS): 30/$80.99 or 90/$231.97
Diovan 80MG Tablets (NOVARTIS): 30/$95.99 or 90/$270.97
Diovan HCT 160-12.5MG Tablets (NOVARTIS): 30/$110.99 or 90/$312.98
Diovan HCT 160-25MG Tablets (NOVARTIS): 30/$126.99 or 90/$362.97
Diovan HCT 320-12.5MG Tablets (NOVARTIS): 30/$142.99 or 90/$394.98
Diovan HCT 320-25MG Tablets (NOVARTIS): 30/$159.98 or 90/$449.96
Diovan HCT 80-12.5MG Tablets (NOVARTIS): 30/$103.99 or 90/$285.97
Exforge 10-160MG Tablets (NOVARTIS): 30/$123.00 or 90/$359.96
Exforge 10-320MG Tablets (NOVARTIS): 30/$152.99 or 90/$438.96
Exforge 5-160MG Tablets (NOVARTIS): 30/$108.99 or 90/$308.95
Exforge 5-320MG Tablets (NOVARTIS): 30/$139.99 or 90/$407.97
Exforge HCT 10-160-12.5MG Tablets (NOVARTIS): 30/$128.99 or 90/$372.95
Exforge HCT 5-160-12.5MG Tablets (NOVARTIS): 30/$106.98 or 90/$300.96
Exforge HCT 5-160-25MG Tablets (NOVARTIS): 30/$108.99 or 90/$309.98
Valturna 150-160MG Tablets (NOVARTIS): 30/$95.99 or 90/$270.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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3. Oparil S, Dyke S, Harris F et al. The efficacy and safety of valsartan compared with placebo in the treatment of patients with essential hypertension. Clin Ther. 1996; 18:797-810. [IDIS 376624] [PubMed 8930424]
4. Holwerda NJ, Fogari R, Angeli P et al. Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: efficacy and safety compared with placebo and enalapril. J Hypertens. 1996; 14:1147-51. [PubMed 8986917]
5. Criscione L, de Gasparo M, Buhlmayer P et al. Pharmacological profile of valsartan: a potent, orally active, nonpeptide antagonist of the angiotensin II AT1-receptor subtype. Br J Pharmacol. 1993; 110:761-771. [PubMed 8242249]
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9. Criscione L, Bradley WA, Buhlmayer P et al. Valsartan: preclinical and clinical profile of an antihypertensive angiotensin-II antagonist. Cardiovasc Drug Rev. 1995; 13:230-50.
10. Anon. Valsartan for hypertension. Med Lett Drugs Ther. 1997; 39:43-4. [PubMed 9137296]
11. Pitt B, Segal R, Martinez FA et al for the ELITE study investigators. Randomized trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet. 1997; 349:747-52. [IDIS 381678] [PubMed 9074572]
12. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]
13. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1995; 37:45-50. [PubMed 7760767]
14. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148: 1023-38.
15. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]
16. Novartis. Lotensin (benazepril hydrochloride) tablets prescribing information. Summit, NJ; 1995 Oct.
17. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.
18. Novartis, East Hanover, NJ: Personal communication.
19. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)
20. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]
21. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.
22. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]
23. Brent RL, Beckman D. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]
24. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol
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