Candesartan 4mg 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
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D (2nd and 3rd trimesters), Category C (1st trimester)
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 Correctly
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension. 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 your medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep the lid tightly closed. If you have a liquid suspension, store it at room temperature and avoid freezing. Discard any unused portion of the liquid suspension after 30 days. Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss 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 get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension. 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 your medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep the lid tightly closed. If you have a liquid suspension, store it at room temperature and avoid freezing. Discard any unused portion of the liquid suspension after 30 days. Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss 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.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Limit alcohol intake as it can increase the blood pressure lowering effect.
- Maintain a healthy diet (low sodium, rich in fruits and vegetables).
- Engage in regular physical activity as advised by your doctor.
- Monitor blood pressure regularly at home if advised.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: Initial 16 mg once daily. Heart Failure: Initial 4 mg once daily.
Dose Range:
4 - 32 mg
Condition-Specific Dosing:
hypertension:
Initial 16 mg once daily; usual maintenance 8-32 mg once daily. Max 32 mg/day.
heart_failure:
Initial 4 mg once daily, titrate up to target dose of 32 mg once daily as tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants <1 year of age.
Child:
Hypertension (1 to <6 years): Initial 0.2 mg/kg once daily (max 16 mg/day). Hypertension (6 to <17 years): Initial 8 mg once daily (max 32 mg/day).
Adolescent:
Hypertension (6 to <17 years): Initial 8 mg once daily (max 32 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required.
Severe:
CrCl <30 mL/min: Consider lower initial dose (e.g., 4 mg once daily) for hypertension. For heart failure, use with caution and monitor closely.
Dialysis:
Candesartan is not removed by hemodialysis. No specific dose adjustment, but monitor closely.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
Consider lower initial dose (e.g., 4 mg once daily) for hypertension. For heart failure, use with caution and monitor closely.
Severe:
Not recommended due to lack of data.
Pharmacology
Mechanism of Action
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 inhibition leads to vasodilation, reduction in aldosterone secretion, decreased sodium and water reabsorption, and ultimately, a reduction in blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
15% (candesartan from candesartan cilexetil)
Tmax:
3-4 hours
FoodEffect:
Minimal effect on absorption; can be taken with or without food.
Distribution:
Vd:
0.13 L/kg
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
9 hours
Clearance:
Not available (primarily renal and biliary excretion)
ExcretionRoute:
Renal (33%) and biliary (67%) excretion of unchanged drug
Unchanged:
Approximately 33% (renal), 67% (biliary)
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-6 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 Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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:
- Severe dizziness or fainting (especially when standing up)
- Swelling of the face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in feet or ankles, unusual tiredness)
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, as well as any symptoms you experienced as a result of these allergies.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase the risk of certain complications.
If you are breast-feeding, as you should not take this medication while nursing.
Special Considerations for Children:
If your child is under 1 year of age, do not administer this medication, as it is not recommended for infants younger than 1 year.
Additional Precautions:
This medication may interact with other drugs or health conditions, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter medications you are taking
+ Any natural products or vitamins you are using
+ Any health problems you have
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety and the effectiveness of your treatment plan.
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, as well as any symptoms you experienced as a result of these allergies.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase the risk of certain complications.
If you are breast-feeding, as you should not take this medication while nursing.
Special Considerations for Children:
If your child is under 1 year of age, do not administer this medication, as it is not recommended for infants younger than 1 year.
Additional Precautions:
This medication may interact with other drugs or health conditions, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter medications you are taking
+ Any natural products or vitamins you are using
+ Any health problems you have
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety and the effectiveness of your treatment plan.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this drug affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. Additionally, have your blood work and other laboratory tests checked as directed by your healthcare provider. 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. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.
When taking this drug 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 consult with your doctor before using these products.
It is also important to discuss alcohol consumption with your doctor 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 conditions may lead to low blood pressure.
Note that this drug 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, do not hesitate to discuss them with your doctor.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this drug affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. Additionally, have your blood work and other laboratory tests checked as directed by your healthcare provider. 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. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.
When taking this drug 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 consult with your doctor before using these products.
It is also important to discuss alcohol consumption with your doctor 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 conditions may lead to low blood pressure.
Note that this drug 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, do not hesitate to discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Profound hypotension (low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, focusing on maintaining blood pressure and fluid status.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- NSAIDs (including COX-2 inhibitors)
- Lithium
- Other antihypertensive agents (additive hypotensive effects)
Moderate Interactions
- Trimethoprim (increased risk of hyperkalemia)
- Heparin (increased risk of hyperkalemia)
- Cyclosporine (increased risk of hyperkalemia)
Minor Interactions
- Alcohol (may enhance hypotensive effect)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Serum Creatinine and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect renal perfusion.
Timing: Prior to initiation
Serum Potassium
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments
Target: <130/80 mmHg (general target, individualized)
Action Threshold: Persistent hypotension or uncontrolled hypertension
Serum Creatinine and BUN
Frequency: Periodically, especially after dose adjustments or in patients with renal impairment
Target: Within normal limits or stable for patient's baseline
Action Threshold: Significant increase (>30% from baseline) or acute kidney injury
Serum Potassium
Frequency: Periodically, especially in patients at risk for hyperkalemia (e.g., renal impairment, concomitant potassium-sparing diuretics)
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (signs of hypotension)
- Swelling of face, lips, tongue, or throat (signs of angioedema)
- Muscle weakness
- Fatigue
- Irregular heartbeat (signs of hyperkalemia)
- Decreased urine output (signs of renal dysfunction)
Special Patient Groups
Pregnancy
Candesartan is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. It should be discontinued as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks, though data are more limited.
Trimester-Specific Risks:
First Trimester:
Category C. Limited human data, but animal studies show adverse effects. Generally avoided.
Second Trimester:
Category D. Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Category D. Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Lactation
Not recommended during breastfeeding. Candesartan is excreted into the milk of lactating rats, and while human data are limited, there is a potential for serious adverse effects in the breastfed infant.
Infant Risk:
Moderate to High (potential for hypotension, hyperkalemia, renal effects in infant).
Pediatric Use
Approved for hypertension in children 1 year of age and older. Dosing is weight-based. Not recommended for heart failure in pediatric patients. Close monitoring of renal function and potassium is essential.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, older patients may have reduced renal function, which warrants careful monitoring of renal parameters and potassium, and potentially a lower starting dose.
Clinical Information
Clinical Pearls
- Candesartan cilexetil is a prodrug; it is converted to the active drug candesartan in the GI tract.
- Unlike ACE inhibitors, ARBs like candesartan do not typically cause a cough, making them a suitable alternative for patients who develop ACE inhibitor-induced cough.
- Monitor for hyperkalemia, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
- Advise patients to report any signs of angioedema immediately, although it is less common with ARBs than with ACE inhibitors.
- Emphasize the critical importance of discontinuing the drug if pregnancy is detected due to the black box warning.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Olmesartan, Irbesartan, Telmisartan, Azilsartan
- ACE Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
- Calcium Channel Blockers: Amlodipine, Nifedipine, Diltiazem, Verapamil
- Diuretics: Hydrochlorothiazide, Furosemide
- Direct Renin Inhibitors: Aliskiren (limited use)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.