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candesartan cilexetil 32 mg tb generic atacand

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Uses

Hypertension

Candesartan cilexetil is used alone or in combination with other classes of antihypertensive agents in the management of hypertension. Angiotensin II receptor antagonists, such as candesartan cilexetil, are considered one of several preferred antihypertensive drugs for the initial management of hypertension; other options include angiotensin-converting enzyme (ACE) inhibitors, calcium-channel blockers, and thiazide diuretics. While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes. 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 or chronic kidney disease; angiotensin II receptor antagonists also may be preferred, generally as an alternative to ACE inhibitors, in hypertensive patients with heart failure or ischemic heart disease and/or postmyocardial infarction.

Efficacy of candesartan cilexetil in the treatment of hypertension in adults has been established in placebo-controlled studies of 4-12 weeks' duration in patients with hypertension of mild to moderate severity. In these patients, candesartan cilexetil dosages of 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. After withdrawal of candesartan cilexetil, blood pressure gradually returns to pretreatment levels; rebound hypertension following abrupt withdrawal of the drug has not been reported.

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 4-16 mg once daily for 6 or 12 months without apparent loss of clinical effect. Clinical studies have shown that the hypotensive effect of candesartan cilexetil in patients with mild to moderate hypertension is greater than that of placebo and comparable to that of usual dosages of enalapril or amlodipine. Like ACE inhibitors, angiotensin II receptor antagonists such as candesartan may produce a smaller blood pressure response in hypertensive black patients compared with nonblack patients.

Efficacy of candesartan has been established in hypertensive pediatric patients 1 to less than 6 years of age and 6 to less than 17 years of age in 2 randomized, double-blind, multicenter, 4-week dose-ranging studies. Dosages of candesartan cilexetil used in these studies were adjusted for body weight to mimic dosages established in adults. Results of these studies indicate that efficacy and tolerability of candesartan in pediatric patients is comparable to that reported in adults. Changes in systolic and diastolic blood pressures from baseline with candesartan therapy in these studies were dose related and similar between the 2 patient age groups; antihypertensive effects were apparent within 1-2 weeks and full effects were observed by week 4. The pharmacokinetics of candesartan in these groups was comparable to that reported in adults and supported once-daily dosing.

In one study, 93 patients 1 to less than 6 years of age (74% with renal disease) received 0.05, 0.2 or 0.4 mg/kg of candesartan cilexetil once daily as an extemporaneously prepared oral suspension. The primary end point in this study was change in trough systolic blood pressure from baseline to the end of the study (i.e., at 4 weeks). Because this study did not include a placebo arm, the change in blood pressure from baseline likely overestimates the true magnitude of candesartan's blood pressure effects. However, reductions from baseline of 6-12 and 5-11 mm Hg in trough systolic blood pressure and diastolic blood pressure, respectively, were observed across the 3 doses of candesartan, supporting the appropriateness of the dosing regimen used. Blood pressure response to candesartan was similar in children with or without renal disease.

In another study, 240 patients 6 to less than 17 years of age were randomly allocated (in a 1: 2: 2: 2 ratio) to receive either placebo or low, medium, or high doses of candesartan. Dosages of candesartan cilexetil were 2, 8, or 16 mg once daily for patients who weighed less than 50 kg and 4, 16, or 32 mg once daily for those who weighed 50 kg or more. Mean age of patients in the study was approximately 13 years; 47% of those enrolled were black and 29% were female. The primary efficacy variable in this study was the placebo-corrected change from baseline in trough sitting systolic blood pressure to the end of week 4 of the study (or the last observation carried forward). The overall placebo-corrected changes in trough sitting systolic blood pressure and sitting diastolic blood pressure ranged from 4.9-7.5 and from 3-6.2 mmHg, respectively, after 4 weeks.

In children 6 to less than 17 years of age, there was a trend for a lesser blood pressure effect in blacks compared with patients of other races. There were too few individuals in the age group of 1 to less than 6 years to determine whether blacks respond differently than other patients to candesartan.

For additional information on the use of angiotensin II receptor antagonists in the management of hypertension, For information on overall principles and expert recommendations for treatment of hypertension,

Heart Failure

Candesartan is used in the management of mild to severe (New York Heart Association [NYHA] class II-IV) heart failure secondary to left ventricular dysfunction (i.e., a left ventricular ejection fraction [LVEF] of 40% or less) to reduce cardiovascular death and heart failure-associated hospitalization.

Current guidelines for the management of heart failure in adults generally recommend a combination of drug therapies to reduce morbidity and mortality, including neurohormonal antagonists (e.g., ACE inhibitors, angiotensin II receptor antagonists, angiotensin receptor-neprilysin inhibitors [ARNIs], β-adrenergic blocking agents (β-blockers), aldosterone receptor antagonists) that inhibit the detrimental compensatory mechanisms in heart failure. Additional agents (e.g., cardiac glycosides, diuretics, sinoatrial modulators [i.e., ivabradine]) added to a heart failure treatment regimen in selected patients have been associated with symptomatic improvement and/or reduction in heart-failure related hospitalizations. Experts recommend that all asymptomatic patients with reduced LVEF (American College of Cardiology Foundation [ACCF]/American Heart Association [AHA] stage B heart failure) receive therapy with an ACE inhibitor and β-blocker to prevent symptomatic heart failure and to reduce morbidity and mortality. In patients with prior or current symptoms of chronic heart failure with reduced LVEF (ACCF/AHA stage C heart failure), ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend inhibition of the renin-angiotensin-aldosterone (RAA) system with an ACE inhibitor, angiotensin II receptor antagonist, or ARNI in conjunction with a β-blocker, and an aldosterone antagonist in selected patients, to reduce morbidity and mortality. While ACE inhibitors have been the preferred drugs for inhibition of the RAA system because of their established benefits in patients with heart failure and reduced ejection fraction, some evidence indicates that therapy with sacubitril/valsartan, an ARNI, may be more effective than ACE inhibitor therapy (enalapril) in reducing cardiovascular death and heart failure-related hospitalization. ACCF, AHA, and HFSA recommend that patients with chronic symptomatic heart failure with reduced LVEF (NYHA class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality. However, in patients in whom an ARNI is not appropriate, continued use of an ACE inhibitor for all classes of heart failure with reduced ejection fraction remains strongly advised. In patients in whom an ARNI or ACE inhibitor is not appropriate, an angiotensin II receptor antagonist may be used.

While angiotensin II receptor antagonists are considered reasonable alternatives in patients who are unable to tolerate ACE inhibitors (e.g., because of cough or angioedema), sensitivity reactions (e.g., various anaphylactoid reactions and/or angioedema) have been reported with use of angiotensin II receptor antagonists, including candesartan.(See Warnings: Sensitivity Reactions, under Warnings/Precautions in Cautions.)

Efficacy of candesartan for the management of heart failure has been studied in a large (2028 patients), multicenter, double-blind, placebo-controlled, randomized study (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity [CHARM]-Alternative) in patients (32% were female and the mean age of all patients was 67 years) with NYHA class II-IV heart failure and a mean LVEF of 30%, who were intolerant of ACE inhibitors. Addition of candesartan cilexetil 4-8 mg once daily (initial dosage, with dosage doubled every 2 weeks to a target dosage of 32 mg once daily [mean daily dosage about 23 mg]) to standard therapy (diuretics, digoxin, β-blockers, spironolactone) was associated with a 23% reduction (compared with placebo) in the primary end point of cardiovascular death or hospitalization for worsened heart failure at a median follow-up of 34 months.

Efficacy of candesartan for the management of heart failure has been studied in a second large (2548 patients), multicenter, double-blind, placebo-controlled, randomized study (CHARM-Added) in patients (21% were female and the mean age of all patients was 64 years) with NYHA class II-IV heart failure and a mean LVEF of 28%. Addition of candesartan cilexetil 4-8 mg once daily (initial dosage, with dosage doubled every 2 weeks to a target dosage of 32 mg once daily [mean daily dosage about 24 mg]) to standard therapy (ACE inhibitors, diuretics, digoxin, β-blockers, spironolactone) was associated with a 15% reduction (compared with placebo) in the primary end point of cardiovascular death or hospitalization for worsened heart failure at a median follow-up of 41 months. Patients receiving combination therapy with drugs that block the renin-angiotensin system (angiotensin II receptor antagonists, ACE inhibitors, aliskiren), should be closely monitored.(See Drug Interactions: Drugs that Block the Renin-Angiotensin System.)

A third large (3023 patients), multicenter, double-blind, placebo-controlled, randomized study (CHARM-Preserved) was conducted in patients (40% were female and the mean age of all patients was 67 years) with NYHA class II-IV heart failure and preserved LVEF (higher than 40%). Addition of candesartan cilexetil 4-8 mg once daily (initial dosage, with dosage doubled every 2 weeks to a target dosage of 32 mg once daily [mean daily dosage about 25 mg]) to standard therapy, including an ACE inhibitor in about 19% of patients, was associated with a moderate reduction in the number of patients hospitalized one or more times for heart failure but no difference in the number of cardiovascular deaths at a median follow-up of 36.6 months.

Diabetic Nephropathy

Both angiotensin II receptor antagonists and ACE inhibitors have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria, and use of a drug from either class is recommended in such patients with modestly elevated (30-300 mg/24 hours) or higher (exceeding 300 mg/24 hours) levels of urinary albumin excretion. The usual precautions of angiotensin II receptor antagonist or ACE inhibitor therapy in patients with substantial renal impairment should be observed.(See Renal Effects under Warnings/Precautions: General Precautions, in Cautions). For additional information on the use of angiotensin II receptor antagonists in the treatment of diabetic nephropathy, and in .

Dosage and Administration

General

Candesartan cilexetil is administered orally, and can be taken without regard to meals.

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. Any strength of candesartan cilexetil tablet can be used to prepare the suspension. 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. A small amount of the vehicle should be added to five 32-mg candesartan cilexetil tablets and the tablets subsequently ground into a smooth paste using a mortar and pestle. The paste should then be added to a container of suitable size. 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. The final amount of suspension should be prepared by adding the remaining vehicle to the container and mixing the suspension thoroughly. The suspension should be dispensed into suitably sized amber polyethylene terephthalate (PET) bottles. 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/86°F), 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.

Hypertension

Dosage of candesartan cilexetil must be individualized and adjusted according to blood pressure response.

Candesartan Therapy

The panel members appointed to the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8 expert panel) state that evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) should be used when available to determine target dosages of antihypertensive agents. Based on such information, an initial adult candesartan cilexetil dosage of 4 mg once daily and a target dosage of 12-32 mg once daily are recommended. The manufacturer states that 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. Experience with dosages exceeding 32 mg daily is limited, and there is no evidence that higher dosages provide additional therapeutic benefit. Target dosages of antihypertensive agents generally can be achieved within 2-4 weeks, but it may take up to several months. The manufacturer states that the antihypertensive effect of candesartan cilexetil generally is evident within 2 weeks, with a maximum blood pressure reduction after 4-6 weeks.

In pediatric patients, candesartan cilexetil may be administered once daily or twice daily in equally divided doses. Dosage should be adjusted according to blood pressure response. 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. In patients 1 to less than 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. In patients 6 to less than 17 years of age who weigh less than 50 kg, the recommended initial dosage is 4-8 mg daily, with a dosage range of 2-16 mg daily. For patients 6 to less than 17 years of age who weigh more than 50 kg, the recommended initial dosage is 8-16 mg daily, with a dosage range of 4-32 mg daily. Safety and efficacy of dosages exceeding 0.4 mg/kg daily (in patients 1 to less than 6 years of age) or 32 mg daily (in patients 6 to less than 17 years of age) have not been established in this patient population. An antihypertensive effect usually is present within 2 weeks following initiation of candesartan therapy, with full effects generally obtained within 4 weeks. Children younger than 1 year of age must not receive candesartan for hypertension.(See Infant Morbidity under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) Safety and efficacy of candesartan have not been established in pediatric patients with a glomerular filtration rate less than 30 mL/minute per 1.73 m, and such patients should not receive the drug. For children who cannot swallow tablets, candesartan may be administered as an oral suspension.

Antihypertensive therapy should be titrated until goal blood pressure is achieved. If an adequate blood pressure response is not achieved with candesartan monotherapy, another antihypertensive agent with demonstrated benefit may be added; if goal blood pressure is still not achieved with the use of 2 antihypertensive agents at optimal dosages, a third drug may be added. In patients who experience intolerable adverse effects with candesartan, dosage reduction should be considered; if adverse effects worsen or fail to resolve, it may be necessary to discontinue the angiotensin II receptor antagonist and initiate another class of antihypertensive agent.

Candesartan/Hydrochlorothiazide Fixed-combination Therapy

In patients who do not respond adequately to monotherapy with candesartan cilexetil or, alternatively, with hydrochlorothiazide, combined therapy with the drugs can be used. When combination therapy is necessary, the manufacturer states that commercially available preparation containing candesartan cilexetil in fixed combination with hydrochlorothiazide should not be used initially. Dosage preferably should first be adjusted by titrating the dosage of each drug separately; if it is determined that the optimum maintenance dosage corresponds to the ratio in the commercial combination preparation, this product may be used. The manufacturer states that combined therapy with the commercially available fixed-combination preparation containing 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide can be used in adults whose blood pressure is not adequately controlled by monotherapy with 25 mg of hydrochlorothiazide or in those in whom control of blood pressure is maintained but hypokalemia is problematic at this hydrochlorothiazide dosage. In patients whose blood pressure is not adequately controlled by monotherapy with candesartan cilexetil dosages of 32 mg daily, the commercially available fixed-combination containing 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide, or alternatively, 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide can be used.

Blood Pressure Monitoring and Treatment Goals

Careful monitoring of blood pressure during initial titration or subsequent upward adjustment in dosage of candesartan cilexetil is recommended.

The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure; specific target levels of blood pressure should be individualized based on consideration of multiple factors, including patient age and comorbidities, and the currently available evidence from clinical studies.

Heart Failure

Caution should be observed when initiating candesartan cilexetil therapy in patients with heart failure. For the management of symptomatic heart failure (New York Heart Association [NYHA] class II-IV), the manufacturer recommends an initial candesartan cilexetil dosage of 4 mg once daily, while some experts recommend an initial dosage of 4-8 mg once daily. Dosage should be increased (by doubling the dosage at approximately 2-week intervals) as tolerated to a target dosage of 32 mg once daily. The American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) recommend a maximum candesartan cilexetil dosage of 32 mg once daily in patients with heart failure.

Special Populations

The manufacturer recommends that patients with depletion of intravascular volume (e.g., patients receiving treatment with a diuretic, particularly those with renal impairment) should have this condition corrected prior to initiation of candesartan cilexetil therapy or they should be monitored closely and consideration should be given to administering a lower initial dose of the drug. The manufacturer states that no adjustment in initial candesartan cilexetil dosage is necessary in geriatric patients or in those with mild renal or hepatic impairment. However, the area under the concentration-time curve and peak plasma concentration of candesartan are increased substantially in patients with moderate (Child-Pugh B) hepatic impairment, and the manufacturer states that consideration should be given to initiating candesartan cilexetil therapy at a reduced dosage (e.g., 8 mg once daily). Some clinicians recommend an initial 4- or 8-mg daily dosage of candesartan cilexetil in patients with severe hepatic or renal impairment.

The commercially available preparation containing candesartan cilexetil in fixed combination with hydrochlorothiazide is not recommended for patients with renal impairment whose creatinine clearance is less than 30 mL/minute, and such preparations should be used with caution in patients with hepatic impairment. If a lower initial (less than 8 mg once daily) candesartan cilexetil dosage is selected in patients with moderate hepatic impairment, the commercially available preparation containing candesartan cilexetil in fixed combination with hydrochlorothiazide is not recommended for initial titration, because the appropriate starting dose of candesartan cilexetil is not available as a fixed-ratio preparation. The fixed combination preparation should be individualized and adjusted carefully in patients with hepatic impairment.

Cautions

Contraindications

Known hypersensitivity to candesartan or any ingredient in the formulation.

Concomitant use of candesartan and aliskiren in patients with diabetes mellitus.(See Drug Interactions: Drugs that Block the Renin-Angiotensin System.)

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Drugs that act on the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists) reduce fetal renal function and increase fetal and neonatal morbidity and mortality when used during the second and third trimesters of pregnancy. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Candesartan should be discontinued as soon as possible when pregnancy is detected, unless continued use is considered life-saving. Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy. Cases of fetal and neonatal toxicity in infants born to women who received candesartan cilexetil during pregnancy have been reported during postmarketing experience with the drug. For additional information on the risk of such drugs during pregnancy, see Cautions: Pregnancy, Fertility, and Lactation, in and .

Sensitivity Reactions

Sensitivity reactions, including various anaphylactoid reactions and/or angioedema, have been reported with use of angiotensin II receptor antagonists, including candesartan. Candesartan is not recommended in patients with a history of angioedema associated with or unrelated to ACE or angiotensin II receptor antagonist therapy.

Other Warnings and Precautions

Effects on Potassium

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).(See Drug Interactions: Agents that Increase Serum Potassium.) Serum potassium concentrations should be monitored periodically.

Hypotension

Symptomatic hypotension may occur. Patients at particular risk include those with volume or salt depletion secondary to salt restriction, prolonged diuretic therapy, heart failure, or dialysis. Volume and/or salt depletion should be corrected before initiation of candesartan therapy or a lower initial dosage should be used. 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.

Malignancies

In July 2010, the US Food and Drug Administration (FDA) initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis suggested a possible association between the use of these agents and an increased risk of cancer. The meta-analysis, which combined cancer-related findings from 5 randomized, controlled trials in over 60,000 patients, found a modest but significant increase in the risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist (mostly telmisartan) compared with those in control groups (7.2 versus 6%, respectively; risk ratio 1.08). However, because of several limitations of the study (e.g., trials included in the meta-analysis were not specifically designed to evaluate cancer outcomes, lack of individual patient data), the validity of these findings has been questioned.

Subsequent studies, including a larger, more comprehensive meta-analysis conducted by FDA, have not shown an increased risk of cancer in patients receiving angiotensin II receptor antagonists. FDA's meta-analysis, which included trial-level data from 31 randomized studies (total of approximately 156,000 patients), found no evidence of an increased risk of cancer in patients who received an angiotensin II receptor antagonist compared with those who received other treatments (placebo or active control). The overall rate of new cancer occurrence was essentially the same in both groups of patients (1.82 and 1.84 cases per 100 patient-years, respectively). In addition, there was no difference in the risk of cancer-related death, breast cancer, lung cancer, or prostate cancer between the groups. Based on these results and a review of all currently available data related to this potential safety concern, FDA has concluded that use of angiotensin II receptor antagonists is not associated with an increased risk of cancer.

Renal Effects

Because the renin-angiotensin-aldosterone (RAA) system appears to contribute substantially to maintenance of glomerular filtration in patients with heart failure in whom renal perfusion is severely compromised, renal function may deteriorate markedly (e.g., oliguria, progressive azotemia, renal failure, death) in these patients during therapy with an ACE inhibitor or an angiotensin II receptor antagonist (e.g., candesartan cilexetil). Increases in serum creatinine requiring discontinuance of the drug may occur in patients with heart failure receiving candesartan. Serum creatinine should be monitored during dosage escalation and periodically thereafter. Renal artery stenosis, preexisting renal impairment, and concomitant diuretic therapy also are risk factors for renal impairment during therapy with drugs that inhibit the RAA system. ()

Infant Morbidity

Patients younger than 1 year of age must not receive candesartan for hypertension; drugs that act directly on the renin-angiotensin system can have effects on the development of immature kidneys.

Surgery/Anesthesia

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 renin-angiotensin system. Rarely, hypotension may be severe enough to require volume expansion with IV fluids and/or use of vasopressors.

Fixed-combination Preparations

When candesartan cilexetil is used as a fixed combination that includes hydrochlorothiazide, the cautions, precautions, and contraindications associated with thiazide diuretics must be considered in addition to those associated with candesartan cilexetil.

Specific Populations

Pregnancy

Category D.

Candesartan can cause fetal and neonatal morbidity and mortality when administered to a pregnant woman. Candesartan should be discontinued as soon as possible when pregnancy is detected.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

The effects of candesartan on labor and delivery in humans have not been established.

Lactation

It is not known whether candesartan cilexetil is distributed into breast milk. Because of the potential for serious adverse reactions to candesartan in nursing infants, a decision should be made whether to discontinue nursing or the drug.

Pediatric Use

If oliguria or hypotension occurs in neonates with a history of in utero exposure to candesartan, blood pressure and renal function should be supported; exchange transfusions or dialysis may be required.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

The antihypertensive effects and pharmacokinetics of candesartan have been evaluated in patients 1 to less than 17 years of age in randomized double-blind studies.(See Uses: Hypertension.)

The pharmacokinetics of candesartan in pediatric patients 1 to less than 17 years of age were not modified by age, sex, or body weight. Data are lacking on the pharmacokinetics of candesartan in patients younger than 1 year of age or in children with renal impairment.

Candesartan must not be administered to children younger than 1 year of age.(See Infant Morbidity under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the .

Geriatric Use

No substantial differences in safety and efficacy for the treatment of hypertension have been observed in geriatric patients relative to younger adults, but increased sensitivity cannot be ruled out.

Increased incidence of candesartan-associated adverse effects (e.g., abnormal renal function, hypotension, hyperkalemia) and consequent discontinuance of candesartan have been reported in patients with heart failure who were 75 years of age or older when compared with younger patients.

Renal Impairment

Candesartan should be used with caution in patients with renal impairment.(See Dosage and Administration: Special Populations.)

Hepatic Impairment

Candesartan should be used with caution in patients with hepatic impairment.(See Dosage and Administration: Special Population.)

Common Adverse Effects

Adverse effects occurring in 1% or more of patients receiving candesartan cilexetil in clinical trials included back pain, dizziness, upper respiratory tract infection, pharyngitis, and rhinitis. The incidence of adverse effects was not affected by age, gender, or race.

Drug Interactions

Agents 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. Serum potassium concentrations should be monitored in such patients.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of cytochrome P-450 (CYP) system; pharmacokinetic interaction unlikely.

Drugs that Block the Renin-Angiotensin System

Increased risk of hypotension, hyperkalemia, and changes in renal function (e.g., renal impairment) 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. 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 [GFR] less than 60 mL/minute per 1.73 m).

Cardiac Drugs

Pharmacologic interactions unlikely when candesartan is used concomitantly with cardiac drugs (e.g., digoxin, nifedipine).

Lithium

Pharmacokinetic interaction (increased serum lithium concentrations) when candesartan is used concomitantly with lithium. Monitoring of serum lithium concentrations is recommended during concomitant use.

Warfarin

Pharmacologic interaction unlikely.

Glyburide

Pharmacologic interaction unlikely.

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. These effects usually are reversible. Renal function should be periodically monitored in patients receiving candesartan and NSAIA therapy.

Potential pharmacologic interaction (attenuated antihypertensive effects) when angiotensin II receptor antagonists are used concomitantly with NSAIAs, including selective COX-2 inhibitors.

Oral Contraceptives

Pharmacokinetic interaction unlikely.

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