Candesartan 8mg Tablets
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It is used to treat heart failure (weak heart).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Heart Failure Agent
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Not available
FDA Approved
Jun 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Candesartan is a medication used to treat high blood pressure (hypertension) and heart failure. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. This can reduce the risk of heart attacks, strokes, and kidney problems.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you start feeling well. Establish a routine by taking your medication at the same time every day.
If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, make sure to shake it well before each use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep the container tightly closed. If a liquid suspension is made from tablets, store it at room temperature and avoid freezing. Discard any unused portion of the liquid suspension after 30 days. Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, consult your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you start feeling well. Establish a routine by taking your medication at the same time every day.
If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, make sure to shake it well before each use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep the container tightly closed. If a liquid suspension is made from tablets, store it at room temperature and avoid freezing. Discard any unused portion of the liquid suspension after 30 days. Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, consult your doctor for guidance.
Lifestyle & Tips
- Take medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Monitor your blood pressure regularly at home as advised by your doctor.
- Limit sodium intake in your diet as directed by your doctor or dietitian.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor, as this medication can increase potassium levels.
- Maintain a healthy lifestyle including regular exercise, a balanced diet, and limiting alcohol intake.
- Inform your doctor or dentist that you are taking candesartan before any surgery or dental procedures.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 8-16 mg orally once daily; Heart Failure: 4 mg orally once daily, titrate to 32 mg once daily as tolerated
Dose Range:
4 - 32 mg
Condition-Specific Dosing:
hypertension:
Initial 8-16 mg once daily, maintenance 8-32 mg once daily. Max 32 mg/day.
heartFailure:
Initial 4 mg once daily, double dose at 2-week intervals to target 32 mg once daily as tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (contraindicated in infants <1 year due to renal effects)
Child:
Hypertension (1 to <6 years): Initial 0.2 mg/kg once daily, max 0.4 mg/kg once daily. Hypertension (6 to <17 years, <50 kg): Initial 4 mg once daily, max 16 mg once daily. Hypertension (6 to <17 years, ≥50 kg): Initial 8 mg once daily, max 32 mg once daily.
Adolescent:
Hypertension (6 to <17 years, ≥50 kg): Initial 8 mg once daily, max 32 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required.
Severe:
Consider lower initial dose (e.g., 4 mg) in patients with severe renal impairment (CrCl <30 mL/min/1.73 m²).
Dialysis:
No dose adjustment needed for patients on hemodialysis, but monitor closely.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
Consider lower initial dose (e.g., 4 mg) in patients with moderate hepatic impairment. Use with caution.
Severe:
Not recommended in severe hepatic impairment due to lack of data.
Pharmacology
Mechanism of Action
Candesartan cilexetil is a prodrug that is rapidly and completely hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. It blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral vascular resistance, and reduced blood pressure. It does not inhibit ACE (kininase II) and thus does not potentiate bradykinin, which may explain the lower incidence of cough compared to ACE inhibitors.
Pharmacokinetics
Absorption:
Bioavailability:
15% (of candesartan from candesartan cilexetil)
Tmax:
3-4 hours
FoodEffect:
Food does not affect the bioavailability of candesartan.
Distribution:
Vd:
0.13 L/kg
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
9-12 hours
Clearance:
Not available
ExcretionRoute:
Renal (26%) and biliary/fecal (73%)
Unchanged:
Approximately 33% (renal) and 67% (biliary/fecal) of an oral dose is excreted as unchanged candesartan.
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-8 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue candesartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Back pain
Flu-like symptoms
Common cold symptoms
Sore throat
Stuffy nose
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Back pain
Flu-like symptoms
Common cold symptoms
Sore throat
Stuffy nose
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
- Unusual swelling of the face, lips, tongue, or throat (signs of angioedema) - seek immediate medical attention
- Difficulty breathing or swallowing
- Signs of high potassium: unusual tiredness, muscle weakness, slow or irregular heartbeat
- Signs of kidney problems: decreased urination, swelling in feet or ankles
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, especially if you have diabetes or kidney problems.
If you are breastfeeding, as you should not breastfeed while taking this medication.
For Parents and Caregivers:
* If your child is under 1 year of age, do not administer this medication, as it is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, especially if you have diabetes or kidney problems.
If you are breastfeeding, as you should not breastfeed while taking this medication.
For Parents and Caregivers:
* If your child is under 1 year of age, do not administer this medication, as it is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Regularly check your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests monitored.
It may take 4 to 6 weeks to experience the full effects of this medication. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor to discuss potential interactions.
If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication. When taking this medication for high blood pressure, be cautious with over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids. Always discuss the use of these products with your doctor before taking them.
It is also important to talk to your doctor before consuming alcohol while taking this medication. In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.
Note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, be sure to discuss them with your doctor.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Regularly check your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests monitored.
It may take 4 to 6 weeks to experience the full effects of this medication. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor to discuss potential interactions.
If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication. When taking this medication for high blood pressure, be cautious with over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids. Always discuss the use of these products with your doctor before taking them.
It is also important to talk to your doctor before consuming alcohol while taking this medication. In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.
Note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, be sure to discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Severe low blood pressure (hypotension)
- Dizziness
- Fainting
- Tachycardia (rapid heartbeat)
- Bradycardia (slow heartbeat)
What to Do:
If overdose is suspected, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic, focusing on maintaining blood pressure and fluid status. Hemodialysis is unlikely to be effective for removing candesartan.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes mellitus or renal impairment [GFR <60 mL/min/1.73 m²])
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- NSAIDs (including selective COX-2 inhibitors)
- ACE inhibitors (dual blockade of RAAS)
Moderate Interactions
- Lithium
- Other antihypertensive agents (additive hypotensive effect)
- Trimethoprim (risk of hyperkalemia)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, especially important in patients with pre-existing renal impairment or those at risk.
Timing: Prior to initiation
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with known or suspected hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly after dose changes, then monthly or quarterly)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Persistent elevation above target, or symptomatic hypotension
Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)
Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months or as clinically indicated)
Target: Stable within normal limits or acceptable baseline variation
Action Threshold: Significant increase (>30% from baseline or progressive increase), or signs of acute kidney injury
Serum Potassium (K+)
Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months or as clinically indicated)
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L (especially >6.0 mEq/L), or symptomatic hyperkalemia
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (signs of hypotension)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing
- Unusual fatigue
- Muscle weakness or cramps (signs of hyperkalemia)
- Changes in urine output
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks, though data are limited.
Trimester-Specific Risks:
First Trimester:
Limited human data; potential risk cannot be excluded. Generally avoided.
Second Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
Third Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
Lactation
Not recommended during breastfeeding. Candesartan is excreted into the milk of lactating rats, and it is unknown if it is excreted in human milk. Due to the potential for serious adverse effects in the breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Possible risk of adverse effects (e.g., hypotension, renal effects) in breastfed infant. L3 (Moderately Safe) or L4 (Possibly Hazardous) depending on source, but generally advised against.
Pediatric Use
Approved for hypertension in children 1 to <17 years of age. Contraindicated in infants less than 1 year of age due to potential adverse effects on the developing kidney. Dosing is weight-based and requires careful titration.
Geriatric Use
No initial dose adjustment is generally required based on age alone. However, older patients may have reduced renal function, which should be considered. Monitor renal function and potassium levels closely.
Clinical Information
Clinical Pearls
- Candesartan is a good alternative for patients who develop a cough with ACE inhibitors, as it does not affect bradykinin metabolism.
- It is effective for both hypertension and heart failure, offering a dual benefit in patients with both conditions.
- Patients should be advised to avoid sudden changes in position to minimize orthostatic hypotension.
- Hyperkalemia risk is increased when co-administered with potassium-sparing diuretics, potassium supplements, or other drugs that increase potassium (e.g., trimethoprim, NSAIDs).
- Regular monitoring of blood pressure, renal function, and serum potassium is crucial, especially during initiation and dose titration.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, Irbesartan, Olmesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem
- Beta-blockers: Metoprolol, Carvedilol
- Direct Renin Inhibitors: Aliskiren (limited use)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (8mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.