Candesartan

Candesartan
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: João André Alves Silva, M.D. [2]

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Black Box Warning

WARNING: FETAL TOXICITY

See full prescribing information for complete Boxed Warning.

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

Overview

Candesartan is an angiotensin II receptor blocker that is FDA approved for the {{{indicationType}}} of hypertension and heart failure. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, backache, dizziness, pharyngitis, rhinitis and upper respiratory infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

Starting dosage:

16 mg/day, as monotherapy, in non-volume depleted patients.

Use in hepatic impairment:

Initiate with 8 mg/day. If blood pressure is not controlled by candesartan cilexetil alone, a diuretic may be added.
Candesartan cilexetil may be administered with other antihypertensive agents.

Heart Failure

Initial dosage:

4 mg/day

Target dosage, achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient:

32 mg/day

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of candesartan cilexetil in adult patients.

Non–Guideline-Supported Use

Cerebrovascular accident

Dosing Information

(Dosage)

Diabetic nephropathy

Dosing Information

(Dosage)

Essential hypertension - Left ventricular hypertrophy

Dosing Information

(Dosage)

Kidney disease

Dosing Information

(Dosage)

Migraine

Dosing Information

(Dosage)

Transplantation

Dosing Information

(Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Hypertension

1 to < 17 Years of age

Candesartan cilexetil may be administered once daily or divided into two equal doses.

In children 1 - 6 years of age:

Initial dosage:

0.20 mg/kg/day PO

Further dosages:

0.05 to 0.4 mg/kg per day PO

Children 6 - 17 years of age:

Less than 50 kg

Initial dosage:

4 to 8 mg/day PO

Further dosages:

2 to 16 mg per day PO

Greater than 50 kg

Initial dosage:

8 to 16 mg/day PO

Further dosages:

4 to 32 mg/day PO

For patients who can not swallow a pill, follow the instructions below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension:

Prepare the vehicle by adding equal volumes of 1Ora-Plus® (80 mL) and 1Ora-Sweet SF® (80 mL) or, alternatively, use, 1,2Ora-Blend SF® (160 mL).
Add a small amount of vehicle to the required number of ATACAND tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle.
Add the paste to a preparation vessel of suitable size.
Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary.
Prepare the final volume by adding the remaining vehicle.
Mix thoroughly.
Dispense into suitably sized amber PET bottles.
Label with an expiry date of 100 days and include the following instructions:

Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle.
Do not freeze.
Shake well before each use.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of candesartan cilexetil in children.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non-Guideline-Supported Use of candesartan cilexetil in adult patients.

Contraindications

Hypersensitivity to candesartan.
Do not co-administer aliskiren with candesartan cilexetil in diabetic patients.

Warnings

WARNING: FETAL TOXICITY

See full prescribing information for complete Boxed Warning.

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

Fetal Toxicity

Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include:

When pregnancy is detected, discontinue candesartan cilexetil as soon as possible.
Oral doses ≥10 mg of candesartan cilexetil/kg/day administered to pregnant rats during late gestation and continued through lactation were associated with reduced survival and an increased incidence of hydronephrosis in the offspring. The 10-mg/kg/day dose in rats is approximately 2.8 times the maximum recommended daily human dose (MRHD) of 32 mg on a mg/m2 basis (comparison assumes human body weight of 50 kg).
Candesartan cilexetil given to pregnant rabbits at an oral dose of 3 mg/kg/day (approximately 1.7 times the MRHD on a mg/m2 basis) caused maternal toxicity (decreased body weight and death) but, in surviving dams, had no adverse effects on fetal survival, fetal weight, or external, visceral, or skeletal development.
No maternal toxicity or adverse effects on fetal development were observed when oral doses up to 1000 mg of candesartan cilexetil/kg/day (approximately 138 times the MRHD on a mg/m2 basis) were administered to pregnant mice.

Morbidity in Infants

Children < 1 year of age must not receive candesartan cilexetil for hypertension. Drugs that act directly on the renin-angiotensin system (RAS) can have effects on the development of immature kidneys.

Hypotension

Candesartan cilexetil can cause symptomatic hypotension.
Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
Patients with symptomatic hypotension may require temporarily reducing the dose of candesartan cilexetil, diuretic or both, and volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with candesartan cilexetil.
In the CHARM program (heart failure patients), hypotension was reported in 18.8% of patients on candesartan cilexetil versus 9.8% of patients on placebo. The incidence of hypotension leading to drug discontinuation in candesartan cilexetil-treated patients was 4.1% compared with 2.0% in placebo-treated patients. In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, hypotension was reported in 22.6% of patients treated with candesartan cilexetil versus 13.8% treated with placebo.
Monitoring of blood pressure is recommended during dose escalation and periodically thereafter.
Major Surgery/Anesthesia

Hypotension may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists, including candesartan cilexetil, due to blockade of the renin-angiotensin system. Very rarely, hypotension may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.

Impaired Renal Function

Monitor renal function periodically in patients treated with candesartan cilexetil. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend, in part, on the activity of the renin-angiotensin system (e.g., patient 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 when treated with candesartan cilexetil. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on candesartan cilexetil.
In the CHARM program (heart failure patients), the incidence of abnormal renal function (e.g., creatinine increase) was 12.5% in patients treated with candesartan cilexetil versus 6.3% in patients treated with placebo. The incidence of abnormal renal function (e.g., creatinine increase) leading to drug discontinuation in candesartan cilexetil-treated patients was 6.3% compared with 2.9% in placebo-treated patients. In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, the incidence of abnormal renal function (e.g., creatinine increase) was 15% in patients treated with candesartan cilexetil versus 9% in patients treated with placebo.

Hyperkalemia

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia.
Monitor serum potassium periodically.
In the CHARM program (heart failure patients), the incidence of hyperkalemia was 6.3% in patients treated with candesartan cilexetil versus 2.1% in patients treated with placebo. The incidence of hyperkalemia leading to drug discontinuation in candesartan cilexetil-treated patients was 2.4% compared with 0.6% in placebo-treated patients. In the CHARM-Added program where candesartan or placebo was given in addition to ACE inhibitors, the incidence of hyperkalemia was 9.5% in patients treated with candesartan cilexetil versus 3.5% in patients treated with placebo.

Adverse Reactions

Clinical Trials Experience

Adult Hypertension:

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo.
The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (ie, 108 of 3260) of patients treated with candesartan cilexetil as monotherapy and 3.5% (ie, 39 of 1106) of patients treated with placebo. In placebo-controlled trials, discontinuation of therapy due to clinical adverse events occurred in 2.4% (ie, 57 of 2350) of patients treated with candesartan cilexetil and 3.4% (ie, 35 of 1027) of patients treated with placebo.

Pediatric Hypertension

Among children in clinical studies, 1 in 93 children age 1 to < 6 and 3 in 240 age 6 to < 17 experienced worsening renal disease. The association between candesartan and exacerbation of the underlying condition could not be excluded.

Heart Failure

The adverse event profile of candesartan cilexetil in adult heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing candesartan cilexetil in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued candesartan cilexetil for adverse events vs. 16.1% of placebo patients.

Central Nervous System

Respiratory

Miscellaneous

Back pain

Postmarketing Experience

The following adverse reactions were identified during post-approval use of candesartan cilexetil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

The following have been very rarely reported in post-marketing experience:

Digestive

Abnormal hepatic function
Hepatitis

Hematologic

Immunologic

Angioedema

Metabolic and Nutritional Disorders

Hyperkalemia
Hyponatremia

Respiratory system disorders

Cough

Skin and Appendages Disorders

Drug Interactions

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Drug 4
Drug 5

Drug 1

(Description)

Drug 2

(Description)

Drug 3

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Drug 4

(Description)

Drug 5

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Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

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Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

Solution 1
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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

Solution 1
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Incompatible

Solution 1
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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Candesartan
Systematic (IUPAC) name
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Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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Condition 2

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How Supplied

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Storage

There is limited information regarding Candesartan Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Candesartan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Candesartan Brand Names in the drug label.

Look-Alike Drug Names

(Paired Confused Name 1a) — (Paired Confused Name 1b)
(Paired Confused Name 2a) — (Paired Confused Name 2b)
(Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.