Candesartan
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
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WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
|
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.
|
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
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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
{{#ask: Page Name::Candesartan |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Candesartan |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.