Candesartan cilexetil, a nonpeptide tetrazole derivative, is an angiotensin II receptor antagonist (also referred to as an angiotensin II receptor blocker [ARB]).1, 2, 9
Candesartan cilexetil alone or in combination with other antihypertensive agents, is used for the treatment of hypertension in adults and children 1 to <17 years of age.1
Efficacy of candesartan cilexetil for the treatment of hypertension in adults has been established in several placebo-controlled studies of 4-12 weeks' duration in patients with mild to moderate hypertension (baseline diastolic blood pressures 95-114 mm Hg).1 In these patients, candesartan cilexetil 8-32 mg daily decreased systolic blood pressure by about 8-12 mm Hg and diastolic blood pressure by about 4-8 mm Hg 24 hours after dosing.1 These antihypertensive effects were seen within 2 weeks of initiating therapy, with full effects in 4 weeks.1 Blood pressure effects were maintained for 24 hours, with trough to peak ratios of blood pressure effect generally over 80%.1
The efficacy of candesartan cilexetil for long-term use (i.e., exceeding 12 weeks) has been established in 2 open-label, prospective studies in which the drug was administered in dosages of 4-16 mg once daily for 6 or 12 months without apparent loss of clinical effect.1, 3, 16 A total of 632 primarily White, adult patients were enrolled and given candesartan cilexetil following a placebo run-in phase.16 Over 6 months of treatment, sitting systolic blood pressure decreased from a mean baseline of 161.7 to 142.7 mm Hg (difference of 19 mm Hg), with 80% of 388 patients achieving blood pressure normalization.16 Similar results were seen at 12 months, with 73.8% of 244 patients achieving blood pressure normalization.16
A meta-analysis evaluated 12 randomized controlled trials enrolling a total of 3644 adult patients and comparing the efficacy of candesartan cilexetil to losartan for blood pressure control.1632 Candesartan cilexetil, with or without hydrochlorothiazide, at dosages ranging from 8-32 mg was more effective than losartan (dosages of 50-100 mg, given with or without hydrochlorothiazide) in reducing blood pressure.1632
Clinical studies have also shown that the hypotensive effect of candesartan cilexetil in patients with mild to moderate hypertension is comparable to that of usual dosages of enalapril or amlodipine.1, 2, 3, 17, 18
The CINCH (Candesartan in Children with Hypertension) study was a randomized, double-blind trial enrolling pediatric patients 1-17 years of age with hypertension.1635 Patients 1 to <6 years of age and patients 6 to <17 years of age were treated and analyzed separately.59, 1635 Patients 1 to <6 years of age weighing 10-40 kg were randomized to treatment with candesartan cilexetil given as an oral suspension at 1 of 3 dosage levels (0.05, 0.2, or 0.4 mg/kg) for 4 weeks.1635 Patients completing the 4-week treatment period were continued in a long-term (1-year) open-label study, with candesartan cilexetil given at a dosage of 0.2-0.4 mg/kg per day.1635
Ninety-three patients were enrolled in the 4-week trial; mean age was 3.1 years, 64.5% were male, 76.3% were White, 18.3% were Black, and 74.2% had renal disease.1635 After 4 weeks of treatment with candesartan cilexetil, mean systolic blood pressure declined by 6-12 mm Hg and mean diastolic blood pressure by 5.2-11.1 mm Hg, with greater reductions seen with 0.2 and 0.4 mg/kg dosing.1635 Eighty-one patients completed the 1-year open label study.1635 Blood pressure control was maintained at week 56, with a mean blood pressure of 102/62.5 mm Hg.1635 Response rate (full systolic and diastolic blood pressure control) at 56 weeks was 54.1%.1635
Patients 6 to <17 years of age enrolled in the CINCH trial also underwent a 4-week, dose-ranging study followed by a 1-year, open-label treatment period.59 A total of 240 patients were randomly allocated (in a 1:2:2:2 ratio) to receive either placebo or 2, 8, or 16 mg of candesartan cilexetil for patients weighing <50 kg and 4, 16, or 32 mg for patients weighing ≥50 kg.1, 59 Enrolled patients were a mean 12.9 years of a 47% were Black, and 29% were female.1 At 4 weeks, least squares mean changes from baseline were -10.22 mm Hg for systolic blood pressure and -6.56 mm Hg for diastolic blood pressure across all candesartan cilexetil doses compared to -3.66 or -1.80 mm Hg with placebo, respectively.59 For the 1-year, open-label period, 237 patients were enrolled; response rate with candesartan was 52% at 1 year.59 The response rate was lower for Black patients compared to non-Black patients (43 versus 61%).59
The principal goal of preventing and treating hypertension is to reduce the risk of cardiovascular and renal morbidity and mortality, including target organ damage.1200, 1300 The relationship between blood pressure and cardiovascular disease is continuous, consistent, and independent of other risk factors.1200, 1300 The higher the blood pressure, the more likely the development of coronary artery disease, heart failure, stroke, and chronic kidney disease across all ages and ethnic groups.1200, 1300 Each 20-mm Hg increment in systolic blood pressure or 10-mm Hg increment in diastolic blood pressure has been shown to double the risk of death from stroke, heart disease, or other vascular disease.171, 1200, 1300
Accurate blood pressure measurement in the office or clinic is essential for proper diagnosis and management of hypertension.1200, 1300, 1302 Out-of-office blood pressure measurements are recommended to confirm the diagnosis of hypertension.1200, 1300, 1642 Blood pressure categories range from normal to different grades/stages of hypertension and are intended to align therapeutic approaches with blood pressure levels.1300, 1302 Guidelines published in 2025 written and developed by the American College of Cardiology (ACC), the American Heart Association (AHA), and several other US professional organizations define stage 1 hypertension as a systolic blood pressure of 130-139 mm Hg or a diastolic blood pressure of 80-89 mm Hg.1200 Treatment recommendations generally include nonpharmacologic therapy with consideration of pharmacologic therapy based on cardiovascular risk.1200, 1300, 1302, 1642
Comprehensive guidelines for the management of hypertension have been published by various authoritative groups.501, 1200, 1300, 1301, 1302, 1642 The first such guideline was published by the National Heart Lung and Blood Institute (NHLBI) in 1977, followed by a series of Joint National Committee (JNC) guidelines with JNC8 being the last iteration of these guidelines in 2014.501, 1200 The ACC, AHA, and other experts, including the International Society of Hypertension (ISH), have published more recent clinical practice guidelines for the treatment of hypertension.1200, 1300, 1302, 1642 These guidelines all state that lifestyle/behavioral modifications (e.g., weight reduction in patients who are overweight or obese, dietary changes, sodium reduction, potassium supplementation, increased physical activity, moderation of alcohol intake, smoking cessation, stress reduction) are essential in the management of hypertension and should be implemented to lower blood pressure and reduce total cardiovascular risk.1200, 1300, 1302, 1642 The decision whether to initiate antihypertensive drug therapy should be based on blood pressure levels while also considering cardiovascular risk factors.1200, 1300, 1302, 1642 The 2025 ACC/AHA guidelines recommend initiation of drug therapy in all patients with confirmed blood pressure ≥140/90 mm Hg.1200 These guidelines also recommend initiation of drug therapy in patients with blood pressure ≥130/80 mm Hg who have clinical cardiovascular disease, diabetes, or chronic kidney disease (CKD), or who are at increased short-term cardiovascular disease risk.1200 In patients with hypertension and low cardiovascular risk, the 2025 ACC/AHA guidelines recommend initiation of drug therapy if blood pressure remains ≥130/80 mm Hg after a 3- to 6-month trial of lifestyle interventions.1200
Current evidence-based practice guidelines for the management of hypertension in adults generally recommend the use of drugs from 4 classes of antihypertensive agents (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, long-acting dihydropyridine calcium-channel blockers, and thiazide or thiazide-like diuretics); data from clinical outcome trials indicate that lowering blood pressure with any of these drug classes can reduce the complications of hypertension and provide similar cardiovascular risk reduction benefits.501, 503, 1200, 1300, 1302, 1642 However, recommendations for initial drug selection and use in specific patient populations may vary across these guidelines.501, 503, 1200 Ultimately, choice of antihypertensive therapy should be individualized, considering the clinical characteristics of the patient (e.g., age, ethnicity/race, comorbid conditions, cardiovascular risk factors) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, costs).501, 503, 510, 1200, 1302, 1305, 1642 Angiotensin II receptor antagonists or ACE inhibitors may be particularly useful in the management of hypertension in patients with certain coexisting conditions such as diabetes mellitus, chronic coronary artery disease, heart failure, peripheral artery disease, or CKD.1200 Other antihypertensive drugs such as nondihydropyridine calcium-channel blockers, beta-adrenergic blockers, direct vasodilators, alpha-1 blockers, loop diuretics, and aldosterone antagonists are available, but generally recommended as second-line agents or only in specific clinical situations.1200
Experts state that initiation of drug therapy with a single first-line antihypertensive drug is reasonable in adults with stage 1 hypertension (systolic blood pressure 130-139 and diastolic blood pressure 80-89 mm Hg), older adults (e.g., frail), or in those with a history of hypotension or multiple drug-related adverse events; this should be followed by dosage titration and sequential addition of other antihypertensive drugs as need to achieve the target blood pressure.1200 Because most patients with hypertension will require at least 2 antihypertensive drugs to achieve adequate blood pressure control, use of single-pill combinations is generally recommended to improve adherence and blood pressure control when available.1200, 1302 Drug regimens with complementary activity, where a second antihypertensive agent is used to block compensatory responses to the first agent or affect a different pressor mechanism, can result in additive blood pressure lowering and are preferred.1200 Drug combinations that have similar mechanisms of action or clinical effects (e.g., the combination of an ACE inhibitor and an angiotensin II receptor antagonist) generally should be avoided.1200 Antihypertensive drug dosages should be adjusted and/or other agents substituted or added until goal blood pressure is achieved.1200 After initiation of antihypertensive drug therapy, a blood pressure goal of <130/80 mm Hg within 3 months is generally recommended if tolerated, but should be individualized.1200, 1301, 1302 While there is evidence from a randomized controlled study (SPRINT) demonstrating that intensive systolic blood pressure lowering (to <120 mm Hg) may be beneficial in patients with increased risk of cardiovascular disease, the study excluded patients with diabetes mellitus or prior stroke, and those younger than 50 years of age, which may decrease the generalizability of these findings.1210, 1219
The 2025 ACC/AHA hypertension guidelines make specific recommendations for patients with hypertension and certain comorbidities.1200 In patients with hypertension and CKD (i.e., estimated glomerular filtration rate [eGFR] <60 mL/minute per 1.73 m2) and albuminuria of ≥30 mg/g, with or without diabetes, use of either an angiotensin II receptor antagonist or an ACE inhibitor, but not both, is recommended.1200 Use of either an ACE inhibitor or an angiotensin II receptor antagonist should be considered in patients with hypertension and diabetes with mild albuminuria (<30 mg/g).1200 Thiazide-type diuretics, ACE inhibitors, or angiotensin II receptor antagonists are the recommended drug classes in patients with hypertension who have had an ischemic stroke, transient ischemic attack, or intracerebral hemorrhage.1200
The 2025 ACC/AHA guidelines also provide recommendations for the management of patients with resistant hypertension (defined as blood pressure above goal despite treatment with 3 antihypertensive medications with complementary mechanisms of action, including a diuretic at maximally tolerated doses, or blood pressure at goal but requiring 4 or more medications).1200 Risk factors for resistant hypertension include older age, obesity, chronic kidney disease, and diabetes; such patients have a ≥50% higher risk of MI, stroke, end-stage kidney disease, and cardiovascular death than adults with hypertension without resistance to treatment.1200 In adults with uncontrolled resistant hypertension despite optimal treatment with first-line antihypertensive therapies, additional agents such as a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone), beta-adrenergic blocker, alpha-adrenergic blocker, amiloride, central sympatholytic drugs (e.g., clonidine), dual endothelin receptor antagonists (e.g., aprocitentan), or direct vasodilators (e.g., hydralazine) may be considered for further blood pressure reduction.1200
Specific guidelines and recommendations for the management of hypertension in pregnancy have been published by experts such as ACC/AHA and the American College of Obstetricians and Gynecologists (ACOG).1200, 1305, 1306 First-line oral antihypertensive drugs generally recommended in pregnant patients include labetalol, nifedipine (extended-release), or methyldopa.1200, 1302, 1305 Renin-angiotensin system (RAS) blockers (e.g., ACE inhibitors, angiotensin II receptor antagonists, direct renin inhibitors) are contraindicated during pregnancy due to adverse fetal and neonatal outcomes.1200, 1300, 1302, 1305
The American Academy of Pediatrics (AAP) has published a clinical practice guideline for the management of high blood pressure in children and adolescents.1150 The guideline recommends calcium-channel blockers (e.g., nifedipine, amlodipine), ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics for the initial management of hypertension in children requiring drug therapy.1150
Candesartan is used for the treatment of heart failure (New York Heart Association [NYHA] class II-IV) in adults with left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] ≤40%).1
Efficacy of candesartan for the management of heart failure has been studied in the CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity)-Alternative trial, a multicenter, double-blind, placebo-controlled, randomized study enrolling 2028 patients intolerant to ACE inhibitors.1 Patients were randomly assigned to placebo or candesartan cilexetil (4-8 mg, titrated to a target dosage of 32 mg) once daily in addition to standard therapy; concomitant drugs at baseline included diuretics (85%), digoxin (46%), beta-blockers (55), and spironolactone (24%).1, 52 The primary outcome was cardiovascular death or unplanned hospital admission for management of worsening heart failure. 52
Patients were a mean 67 years of age, 32% were female, 88% were of European ethnicity, 48% were NYHA class II, 49% were NYHA class III, and 4% were NYHA class IV.1, 52 The mean LVEF was 30%.1 All patients were intolerant to ACE inhibitors.1 After a median follow-up of 34 months, the primary outcome occurred in 33% of the candesartan group and 40% of the placebo group; this represented a 23% reduction in risk of the primary outcome with candesartan.1, 52 When components of the primary outcome were analyzed individually, no substantial difference was observed for cardiovascular death; however, rates of heart failure hospitalization were substantially decreased with candesartan.52
Efficacy of candesartan for the management of heart failure was also studied in a second multicenter, double-blind, placebo-controlled, randomized study enrolling 2548 patients (CHARM-Added).1, 53 Candesartan cilexetil (4-8 mg once daily initially, titrated to a target dosage of 32 mg daily) or placebo was added to standard therapy for heart failure that included an ACE inhibitor; other concomitant drugs at baseline included diuretics (90%), digoxin (58%), beta-blockers (55%), and spironolactone (17%).53 The primary outcome was cardiovascular death or unplanned hospital admission for management of worsening heart failure.53
Patients were a mean 64 years of a 21% were female, 24% were NYHA class II, 73% were NYHA class III, and 3% were NYHA class IV.1, 53 The mean LVEF was 28%.1 Approximately 90% of patients were of European ethnicity; 5% were Black.53 After a median of 41 months, candesartan cilexetil was associated with a 15% reduction in the primary outcome over placebo.1 Candesartan cilexetil also reduced the incidence of cardiovascular death and heart failure hospitalization compared to placebo.1
A third multicenter, double-blind, placebo-controlled, randomized study (CHARM-Preserved) enrolled 3023 patients with NYHA class II-IV heart failure, a history of hospitalization due to cardiac reasons, and a preserved LVEF† (>40%).134 Candesartan cilexetil (4-8 mg once daily initially, titrated to a target dosage of 32 mg daily) or placebo was added to standard therapy, including an ACE inhibitor; other concomitant drugs at baseline included beta-blockers (56%), diuretics (75%), spironolactone (11.5%), and digoxin (28%).134 The primary outcome was cardiovascular death or unplanned hospitalization for worsening heart failure.134
Enrolled patients were a mean 67 years of a approximately 40% were female, 90-92% were of European ethnicity, and 4-5% of patients were Black.134 At a median follow-up of 36.6 months, the primary outcome occurred in 22 or 24% of patients given candesartan cilexetil or placebo, respectively; this difference was not considered substantial.134
CHARM-Overall evaluated the effects of candesartan cilexetil on morbidity and mortality in patients with heart failure enrolled in the CHARM trials.528 A total of 7601 patients were enrolled in CHARM-Alternative, CHARM-Added, and CHARM-Preserved.52, 53, 134, 528 After a median of 37.7 months of follow-up, any-cause death occurred in 23 or 25% of patients given candesartan cilexetil or placebo, respectively.528 Cardiovascular deaths were lower among patients given candesartan cilexetil (18%) compared to placebo (20%), but there was no difference between the 2 groups for non-cardiovascular deaths.528 Candesartan cilexetil also reduced the risk of hospitalization related to heart failure (20 or 24% for candesartan cilexetil or placebo, respectively).528
Current guidelines for the management of heart failure recommend guideline-directed medical therapy with a combination of drug therapies to reduce morbidity and mortality, including ACE inhibitors, sodium-glucose cotransporter 2 inhibitors, angiotensin II receptor antagonists, angiotensin receptor-neprilysin inhibitors (ARNIs), β-blockers, and mineralocorticoid receptor antagonists.1000 Diuretics are recommended on an as-needed basis to improve symptoms of congestion and prevent worsening of disease in patients with fluid retention.1000 Once guideline-directed medical therapy is optimized, additional therapies may be considered based on patient-specific factors, including ivabradine, vericiguat, digoxin, polyunsaturated fatty acids, and potassium binders.1000
In patients with structural heart disease who do not have any prior or current signs or symptoms of heart failure (i.e., Stage B disease) who have an LVEF ≤40%, ACE inhibitors should be used to reduce mortality and prevent symptomatic heart failure; angiotensin II receptor antagonists may be used in such patients with a recent MI who are intolerant to ACE inhibitors.1000 In patients with heart failure with reduced ejection fraction (HFrEF) and NYHA class II to III symptoms, use of an ARNI is recommended first-line to reduce morbidity and mortality.1000, 1001 Angiotensin II receptor antagonists are recommended for such patients only when an ARNI is contraindicated, inaccessible, or poorly tolerated.1001 In patients with symptomatic heart failure with mildly reduced ejection fraction (i.e., LVEF 41-49%), angiotensin II receptor antagonists may be considered (particularly in patients with a LVEF on the lower end of the range) to reduce the risk of hospitalizations for heart failure and cardiovascular mortality.1000
Candesartan cilexetil and other angiotensin II receptor antagonists have been used to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria†. 1637
In the CALM (Candesartan And Lisinopril Microalbuminuria) study, candesartan cilexetil was compared to lisinopril and combination therapy with candesartan and lisinopril in 197 patients with diabetes, hypertension, and microalbuminuria.1637
Candesartan cilexetil monotherapy and lisinopril monotherapy were given to 66 and 64 patients, respectively, for 24 weeks; 34 additional patients received candesartan cilexetil/lisinopril combination therapy for 12 weeks followed by candesartan cilexetil monotherapy for 12 weeks, and 35 additional patients received candesartan cilexetil/lisinopril combination therapy for 12 weeks followed by lisinopril monotherapy for 12 weeks.1637 At 12 weeks, both candesartan cilexetil and lisinopril reduced urinary albumin:creatinine ratio from baseline (30 and 46% reduction, respectively).1637 At 24 weeks, all treatments decreased urinary albumin:creatinine ratio, with the greatest reduction from baseline (50%) seen with combination therapy.1637 Combination therapy was similar in effects to lisinopril monotherapy (39%), but more effective than candesartan cilexetil monotherapy (24%).1637
Guidelines from the Kidney Disease: Improving Global Outcomes (KDIGO) recommend initiation of an ACE inhibitor or angiotensin II receptor antagonist in patients with diabetes mellitus, hypertension, and moderately to severely elevated albuminuria (i.e., urine to creatinine ratio >30 mg/g).1600, 1630 Once initiated, these medications should be titrated to the maximum dosage tolerated.1600, 1630 In patients who have diabetes mellitus and albuminuria, but are normotensive †, ACE inhibitors or angiotensin II receptor antagonists may be considered.1600 Treatment with ACE inhibitors or angiotensin II receptor antagonists should be continued unless the serum creatinine concentration increases by >30% within the first month after initiation or following a dosage increase. 1600
Current standards of care from the American Diabetes Association (ADA) and KDIGO provide similar management recommendations for patients with diabetes mellitus and CKD.1631 Treatment recommendations include optimization of glucose management and blood pressure control (<130/80 mm Hg) to slow the progression of CKD.1631 For patients with diabetes mellitus and hypertension with moderate proteinuria (<300 mg/day), use of either an ACE inhibitor or an angiotensin II receptor antagonist is recommended.1631 For patients with severely increased proteinuria (≥300 mg/day), an ACE inhibitor or an angiotensin II receptor antagonist, given at maximally tolerated dosages, is strongly recommended to prevent progression of CKD and reduce the risk of cardiovascular events.1631 These agents are generally not recommended for primary prevention of CKD in patients with diabetes mellitus who are normotensive and have no evidence of CKD.1631
Angiotensin II receptor antagonists have also been used for the management of patients with nondiabetic CKD with moderate or severely increased albuminuria† (i.e., urinary albumin to creatinine ratio >30 mg/g) to prevent progression of CKD and reduce the risk of cardiovascular disease.1200, 1630 Once initiated, these medications should be titrated to the maximum dosage tolerated.1630 KDIGO guidelines state that angiotensin II receptor antagonists can also be considered in patients with CKD and normal to mildly increased albuminuria† (i.e., urinary albumin to creatinine ratio <30 mg/g) when other compelling indications (e.g., hypertension, heart failure, or low ejection fraction) are present.1630
The 2025 ACC/AHA hypertension guidelines also make specific recommendations for patients with hypertension, diabetes mellitus, and CKD.1200 In patients with diabetes mellitus and hypertension with CKD (i.e., eGFR <60 mL/minute per 1.73 m2) and albuminuria of ≥30 mg/g, use of either an angiotensin II receptor antagonist or an ACE inhibitor is recommended to delay the progression of diabetes-related kidney disease.1200 Use of either an ACE inhibitor or an angiotensin II receptor antagonist should also be considered in patients with hypertension and diabetes with mild albuminuria (<30 mg/g).1200
Candesartan cilexetil has been used for migraine prophylaxis†.1638 1639
A randomized, double-blind, placebo-controlled, crossover trial compared candesartan to placebo for prevention of migraines in 60 adult patients with 2-6 migraine attacks per month.1638 The primary outcome was self-recorded days with headaches.1638 Candesartan cilexetil was associated with a 26% reduction in headache days compared to placebo.1638 An additional randomized, triple-blind, placebo-controlled, crossover trial compared candesartan cilexetil to propranolol for migraine prophylaxis.1639 Seventy-two adult patients with ≥2 migraine attacks per month underwent three 12-week treatment periods, with a 4-week washout period between treatments, receiving either candesartan 16 mg, propranolol slow-release 160 mg, or placebo.1639 The primary outcome was days with migraine headache every 4 weeks.1639 Both candesartan and propranolol were more effective than placebo in reducing the number of migraine days from baseline (2.95, 2.91, and 3.53 migraine days per month, respectively).1639 However, no difference was observed between candesartan and propranolol for migraine day reductions.1639
A consensus statement on migraine treatment from the American Headache Society states that preventative treatment for migraine should be considered for patients with attacks that interfere with daily activities despite acute treatment; frequent migraine attacks (≥3 with severe disability, ≥4 with some disability, or ≥6 with no disability); contraindication to, failure of, or overuse of acute treatments; adverse events with acute treatment; or patient preference.1640 Oral medications with evidence of efficacy for migraine prevention include candesartan, divalproex sodium, metoprolol, propranolol, timolol, and valproate sodium.1640 Preventative treatment should be titrated up to a target dosage and continued for a minimum of 8 weeks at the target dosage prior to assessing efficacy of treatment.1640 Some experts state that candesartan cilexetil may be preferred for preventative medication in patients with hypertension or patients ≥65 years of age to reduce adverse events from treatment.1641
Candesartan cilexetil is administered orally as tablets, and can be taken without regard to meals.1 It is also commercially available in fixed-combination tablets containing candesartan cilexetil and hydrochlorothiazide; see the full prescribing information for administration of this combination product.2
Candesartan cilexetil tablets should be stored at 20-25°C (excursions permitted between 15-30°C).1
For pediatric patients who cannot swallow tablets, candesartan may be administered orally as an extemporaneously prepared suspension.1 Candesartan cilexetil oral suspension can be extemporaneously prepared in concentrations within the range of 0.1-2 mg/mL; a concentration of 1 mg/mL generally is suitable for administering most dosages.1 Any strength of candesartan cilexetil tablets can be used to prepare the suspension.1 To prepare a suspension that will yield 160 mL of a 1-mg/mL suspension, equal volumes (80 mL each) of Ora-Plus® and Ora-Sweet SF® or, alternatively, 160 mL of Ora-Blend SF® should be used.1 A small amount of the vehicle should be added to five 32-mg candesartan cilexetil tablets and subsequently ground into a smooth paste using a mortar and pestle.1 The paste should then be added to a container of suitable size.1 The mortar and pestle should be rinsed clean using the vehicle and the resulting vehicle mixture should then be added to the container; this step should be repeated as necessary.1 The final amount of suspension should be prepared by adding the remaining vehicle to the container and mixing the suspension thoroughly.1 The suspension should be dispensed into suitably sized amber polyethylene terephthalate (PET) bottles.1 Each bottle of candesartan suspension should be labeled with an expiration date of 100 days and marked with the following instructions: store at room temperature (below 30°C), use within 30 days after first opening, do not use after the expiration date on the bottle, do not freeze, and shake well before each use.1
Available as candesartan cilexetil; dosage is expressed in terms of the salt.1
Dosage of candesartan cilexetil must be individualized and adjusted according to blood pressure response.1
For the treatment of hypertension, the usual initial dosage of candesartan cilexetil as monotherapy is 16 mg once daily in adults without depletion of intravascular volume and the usual dosage range is 8-32 mg daily, given in 1 dose or 2 divided doses.1 Experience with dosages exceeding 32 mg daily is limited, and there is no evidence that higher dosages provide additional therapeutic benefit.1 The manufacturer states that the antihypertensive effect of candesartan cilexetil generally is evident within 2 weeks, with a maximum blood pressure reduction within 4-6 weeks of treatment.1
If blood pressure is not adequately controlled by candesartan cilexetil alone, a diuretic may be added and it may be administered with other antihypertensive agents.1
For the management of heart failure (New York Heart Association [NYHA] class II-IV) in adults, the usual initial dosage of candesartan cilexetil is 4 mg once daily.1 Dosage should be increased (by doubling the dosage at approximately 2-week intervals) as tolerated to a target dosage of 32 mg once daily.1
In patients with hypertension, diabetes, and albuminuria†, the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines suggest an initial candesartan cilexetil dosage of 16 mg once daily with titration as tolerated to a maximum dosage of 32 mg daily.1600
In patients who are being treated for migraine prevention†, some experts recommend an oral candesartan cilexetil dosage of 8-16 mg daily.1641
In pediatric patients, candesartan cilexetil may be administered once or twice daily in equally divided doses.1 Dosage should be adjusted according to blood pressure response.1 In patients with possible depletion of intravascular volume (e.g., those treated with diuretics, particularly those with impaired renal function), candesartan cilexetil should be initiated under close medical supervision and administration of a lower dosage should be considered.1 In patients 1 to <6 years of age, the recommended initial dosage is 0.2 mg/kg (oral suspension) daily, with a dosage range of 0.05-0.4 mg/kg daily.1 In patients 6 to <17 years of age who weigh <50 kg, the recommended initial dosage is 4-8 mg daily, with a dosage range of 2-16 mg daily.1 For patients 6 to <17 years of age who weigh >50 kg, the recommended initial dosage is 8-16 mg daily, with a dosage range of 4-32 mg daily.1 Safety and efficacy of dosages exceeding 0.4 mg/kg daily (in patients 1 to <6 years of age) or 32 mg daily (in patients 6 to <17 years of age) have not been established.1 An antihypertensive effect usually is present within 2 weeks following initiation of candesartan therapy, with full effects generally obtained within 4 weeks.1 For children who cannot swallow tablets, candesartan may be administered as an oral suspension.1
In patients with mild hepatic impairment, no initial dosage adjustment of candesartan cilexetil is necessary.1 In adults with moderate hepatic impairment being treated for hypertension, an initial dosage of 8 mg daily is recommended.1 Use in severe hepatic impairment has not been studied.1
In adults, no initial dosage adjustment of candesartan cilexetil is necessary in patients with renal impairment.1 In pediatric patients, use is not recommended in patients with a glomerular filtration rate <30 mL/minute per 1.73 m2.1
The manufacturer states that no initial dosage modification of candesartan cilexetil is necessary in geriatric patients.1
Fetal/Neonatal Morbidity and Mortality
A boxed warning about the risk of fetal harm is included in the prescribing information for candesartan.1 Use of candesartan during pregnancy can cause fetal harm.1 Use of drugs that act on the renin-angiotensin system (RAS) during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.1 Oligohydramnios caused by drugs that act on the RAS can result in fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), anuria, hypotension, renal failure, and death.1 Discontinue candesartan as soon as possible when pregnancy is detected.1 In the rare case that there is no appropriate alternative therapy, apprise the mother of the potential risk to the fetus.1 If candesartan is taken during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment; if oligohydramnios is observed, consider alternative treatment.1 Oligohydramnios may not appear until after the fetus has sustained irreversible injury.1 Closely observe neonates who have been exposed to candesartan in utero for signs of hypotension, oliguria, hyperkalemia, and other symptoms of renal impairment.1 If oliguria or hypotension occurs, support blood pressure and renal perfusion.1 Exchange transfusions or dialysis may be required.1
Other Warnings and Precautions
Patients <1 year of age must not receive candesartan for hypertension; drugs that act directly on the RAS can have effects on the development of immature kidneys.1
Symptomatic hypotension may occur.1 Patients at particular risk include those with volume or salt depletion secondary to salt restriction, prolonged diuretic therapy, heart failure, dialysis, diarrhea, or vomiting.1 Volume and/or salt depletion should be corrected before initiation of candesartan therapy.1 In patients with symptomatic hypotension, a temporary reduction in the dosage of candesartan cilexetil and/or of a diuretic may be needed, as well as volume repletion; blood pressure should be monitored during dosage escalation and periodically thereafter.1
Hypotension may occur in patients undergoing major surgery and anesthesia who are receiving angiotensin II receptor antagonists, including candesartan, presumably secondary to blockade of the RAS.1 Rarely, hypotension may be severe enough to require volume expansion with IV fluids and/or use of vasopressors.1
Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the RAS.1 Patients whose renal function may depend in part on activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure while taking candesartan.1
Consider withholding or discontinuing candesartan cilexetil in patients who develop a clinically important reduction in renal function during treatment.1
Monitor renal function periodically in patients treated with candesartan cilexetil.1
Drugs that inhibit the RAS can cause hyperkalemia.1 Hyperkalemia can develop especially in patients receiving agents that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).1
Monitor serum potassium periodically in patients treated with candesartan cilexetil.1
When preparations containing candesartan cilexetil in fixed combination with hydrochlorothiazide are used, the cautions, precautions, and contraindications associated with both drugs must be considered.2 Consult the prescribing information for the fixed combination preparation for specific information.2
Candesartan can cause fetal harm when administered to a pregnant woman.1 Use of drugs that act on the RAS during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.1 Oligohydramnios in pregnant women who use drugs affecting the RAS in the second or third trimester of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), hypotension, and death.1
Discontinue candesartan as soon as possible when pregnancy is detected.1 In the rare case that there is no appropriate alternative therapy, apprise the mother of the potential risk to the fetus.1 If candesartan is taken during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment; if oligohydramnios is observed, consider alternative treatment.1 Oligohydramnios may not appear until after the fetus has sustained irreversible injury.1 Closely observe neonates who have been exposed to candesartan in utero for signs of hypotension, oliguria, hyperkalemia, and other signs of renal impairment.1 If oliguria or hypotension occurs, support blood pressure and renal perfusion.1 Exchange transfusions or dialysis may be required.1
Candesartan is distributed into milk in rats; it is not known whether the drug is distributed into human breast milk.1 Because of the potential for serious adverse reactions to candesartan in breast-feeding infants, advise women not to breast-feed during treatment with candesartan.1
The antihypertensive effects and pharmacokinetics of candesartan have been established in pediatric patients 1 to <17 years of age.1
The pharmacokinetics of candesartan in pediatric patients 1 to <17 years of age are not modified by age, sex, or body weight.1
Safety and efficacy of candesartan in pediatric patients with a glomerular filtration rate <30 mL/minute per 1.73 m2 have not been established.1
Candesartan must not be administered to pediatric patients <1 year of age for hypertension; drugs that act directly on the RAS can have effects on the development of immature kidneys.1
In pharmacokinetic studies of geriatric patients (≥65 years of age), the maximum serum plasma concentration and AUC of candesartan were approximately 50% and 80% higher, respectively.1 In clinical studies evaluating candesartan for hypertension, the antihypertensive effect was similar in patients older and younger than 65 years of age.1
Compared to healthy volunteers, the increases in maximum plasma concentration and AUC of candesartan were 56 and 30%, respectively, in patients with mild hepatic impairment, and 73 and 145%, respectively, in patients with moderate hepatic impairment.1 No dosage adjustment of candesartan is required in patients with mild hepatic impairment.1 In patients with hypertension and moderate hepatic impairment, consider initiation of candesartan at a lower dosage.1 Candesartan has not been studied in patients with severe hepatic impairment.1
In patients with hypertension and renal impairment, candesartan serum concentrations were elevated.1 In patients with severe renal impairment (creatinine clearance <30 mL/minute), the AUC and maximum plasma concentration of candesartan, after repeated dosing, were approximately doubled compared to patients with normal kidney function.1 In patients with hypertension undergoing hemodialysis, the pharmacokinetics of candesartan are similar to patients with hypertension and severe renal impairment.1 Candesartan is not removed by hemodialysis.1
In patients with heart failure and renal impairment, the maximum plasma concentration and AUC of candesartan were 15 and 36% higher, respectively, in patients with mild renal impairment, and 55 and 65% higher, respectively, in patients with moderate renal impairment.1
No initial dosage adjustment is necessary in patients with renal impairment.1
Safety and efficacy of candesartan in pediatric patients with renal impairment have not been established.1
Adverse effects occurring in 1% or more of patients receiving candesartan cilexetil for the management of hypertension and more frequently than placebo include back pain, dizziness, upper respiratory tract infection, pharyngitis, and rhinitis.1
Adverse effects occurring in 1% or more of patients receiving candesartan cilexetil for the management of heart failure and more frequently than placebo include hyperkalemia, hypotension, and abnormal renal function.1
Drugs that Increase Serum Potassium
Concomitant use of candesartan with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that increase serum potassium concentrations may result in hyperkalemia.1 Serum potassium concentrations should be monitored in such patients.1
Drugs that Block the Renin-Angiotensin System
Increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) with concomitant use of other drugs that block the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, aliskiren); when candesartan is used concomitantly with such drugs, blood pressure, renal function, and serum concentrations of electrolytes should be monitored closely.1 Concomitant use of candesartan with aliskiren is contraindicated in patients with diabetes mellitus; in addition, such concomitant use should be avoided in patients with renal impairment (glomerular filtration rate less than 60 mL/minute per 1.73 m2).1
Increased serum lithium concentrations and lithium toxicity have been reported when candesartan is used concomitantly with lithium.1 Monitoring of serum lithium concentrations is recommended during concomitant use.1
Nonsteroidal Anti-inflammatory Agents
Concomitant use of nonsteroidal anti-inflammatory agents (NSAIAs), including selective cyclooxygenase-2 (COX-2) inhibitors, and angiotensin II receptor antagonists may result in deterioration of renal function, including possible acute renal failure, in patients who are geriatric, volume-depleted (including those on diuretic therapy), or who have compromised renal function.1 These effects usually are reversible.1 Renal function should be periodically monitored in patients receiving candesartan and NSAIA therapy.1
Potential pharmacologic interaction (attenuated antihypertensive effects) when angiotensin II receptor antagonists are used concomitantly with NSAIAs, including selective COX-2 inhibitors.1
Candesartan cilexetil, a nonpeptide tetrazole derivative, is a selective inhibitor of the angiotensin II receptor (type AT1).1 Candesartan cilexetil is a prodrug and is hydrolyzed during absorption from the GI tract to candesartan.1 Candesartan has a much greater affinity for the AT1 receptor than for the AT2 receptor.1 Through selective blockade of angiotensin II binding at the AT1 receptor, candesartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 Candesartan does not inhibit the angiotensin converting enzyme (ACE), and does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.1 After 1 week of administration of candesartan cilexetil at a dosage of 8 mg once daily, at peak, the angiotensin II pressor effect was inhibited by about 90% with about 50% inhibition persisting for 24 hours.1
The absolute bioavailability of candesartan is approximately 15% following oral administration of candesartan cilexetil.1 In adults, the peak serum concentration is reached after 3-4 hours after oral administration.1 Administration with food with a high fat content does not affect bioavailability.1 The pharmacokinetics of candesartan are linear after single and repeated administration for oral doses up to 32 mg of candesartan cilexetil.1 Candesartan is highly protein bound (>99%).1 Distribution across the blood-brain barrier is poor, according to animal studies.1 Candesartan is mainly excreted unchanged in urine and feces (via bile), though it also undergoes minor hepatic metabolism by O-deethylation to an inactive metabolite.1 The elimination half-life of candesartan is about 9 hours.1 Following oral administration, approximately 26% of the dose of candesartan is excreted unchanged in the urine.1 After an oral dose of candesartan cilexetil, about 33 and 67% are recovered in the urine and feces, respectively.1 Elimination of candesartan occurs mainly through biliary excretion.1 There is no difference in the pharmacokinetics of candesartan between female and male patients.1 In patients with heart failure (New York Heart Association class II and III), after repeated dosing of candesartan, the AUC was approximately doubled compared to healthy patients.1 The pharmacokinetics in patients with heart failure are similar to the pharmacokinetics in healthy geriatric volunteers.1
In pediatric patients 1-17 years of age, after a single dose, plasma levels of the drug are more than 10-fold higher at peak (about 4 hours) than at 24 hours.1 In pediatric patients 1 to <6 years of age, a dosage of 0.2 mg/kg has similar exposure of the drug to adults given 8 mg.1 Pediatric patients >6 years of age had similar exposure to the drug as adults given the same dose.1 The pharmacokinetics (maximum plasma concentration and AUC) of candesartan in pediatric patients 1 to <17 years of age are not modified by age, sex, or body weight.1 For pediatric patients <1 year of age, the pharmacokinetics of candesartan have not been studied; candesartan cilexetil must not be given to these patients, as drugs that act directly on the renin-angiotensin system (e.g., candesartan cilexetil) can alter normal renal development.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 4 mg* | ANI Pharmaceuticals | |
Candesartan Cilexetil Tablets | ||||
8 mg* | Atacand® | ANI Pharmaceuticals | ||
Candesartan Cilexetil Tablets | ||||
16 mg* | Atacand® | ANI Pharmaceuticals | ||
Candesartan Cilexetil Tablets | ||||
32 mg* | Atacand® | ANI Pharmaceuticals | ||
Candesartan Cilexetil Tablets |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 16 mg with Hydrochlorothiazide 12.5 mg* | Atacand® HCT | ANI Pharmaceuticals |
Candesartan Cilexetil and Hydrochlorothiazide Tablets | ||||
32 mg with Hydrochlorothiazide 12.5 mg* | Atacand® HCT | ANI Pharmaceuticals | ||
Candesartan Cilexetil and Hydrochlorothiazide Tablets | ||||
32 mg with Hydrochlorothiazide 25 mg* | Atacand® HCT | ANI Pharmaceuticals | ||
Candesartan Cilexetil and Hydrochlorothiazide Tablets |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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2. ANI Pharmaceuticals. Atacand HCT® (candesartan cilexetil-hydrochlorothiazide) tablets prescribing information. Baudette, MN; 2020 Aug.
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