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

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• (Dosage)

Condition 2

• Dosing Information

• (Dosage)

Condition 3

• 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

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• (Dosage)

Condition 2

• Dosing Information

• (Dosage)

Condition 3

• Dosing Information

• (Dosage)

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

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.

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Condition 2

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

• Drug 1
• Drug 2
• Drug 3
• Drug 4
• Drug 5

Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

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

(Description)

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

• Solution 1
• Solution 2
• Solution 3

Not Tested

• Solution 1
• Solution 2
• Solution 3

Variable

• Solution 1
• Solution 2
• Solution 3

Incompatible

• Solution 1
• Solution 2
• Solution 3

Y-Site

Compatible

• Solution 1
• Solution 2
• Solution 3

Not Tested

• Solution 1
• Solution 2
• Solution 3

Variable

• Solution 1
• Solution 2
• Solution 3

Incompatible

• Solution 1
• Solution 2
• Solution 3

Admixture

Compatible

• Solution 1
• Solution 2
• Solution 3

Not Tested

• Solution 1
• Solution 2
• Solution 3

Variable

• Solution 1
• Solution 2
• Solution 3

Incompatible

• Solution 1
• Solution 2
• Solution 3

Syringe

Compatible

• Solution 1
• Solution 2
• Solution 3

Not Tested

• Solution 1
• Solution 2
• Solution 3

Variable

• Solution 1
• Solution 2
• Solution 3

Incompatible

• Solution 1
• Solution 2
• Solution 3

TPN/TNA

Compatible

• Solution 1
• Solution 2
• Solution 3

Not Tested

• Solution 1
• Solution 2
• Solution 3

Variable

• Solution 1
• Solution 2
• Solution 3

Incompatible

• Solution 1
• Solution 2
• Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Candesartan
Systematic (IUPAC) name
?
Identifiers
CAS number	?
ATC code	?
PubChem	?
Chemical data
Formula	?
Mol. mass	?
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

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.