Candesartan 16mg 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
Not applicable (Contraindicated in 2nd and 3rd trimesters; avoid in 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, be sure to shake it well before each use. When measuring liquid doses, use the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed. If you've prepared a liquid suspension 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 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, be sure to shake it well before each use. When measuring liquid doses, use the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed. If you've prepared a liquid suspension 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 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.
- Maintain a healthy diet, low in sodium.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Avoid smoking.
- Monitor your blood pressure regularly at home if advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 16 mg once daily. Heart Failure: Initial 4 mg once daily, titrate to 32 mg once daily.
Dose Range:
4 - 32 mg
Condition-Specific Dosing:
Hypertension:
Initial 16 mg once daily; maintenance 8-32 mg once daily. Max 32 mg/day.
Heart Failure:
Initial 4 mg once daily; double dose at 2-week intervals as tolerated, up to 32 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Hypertension (1 to <6 years): Initial 0.2 mg/kg once daily, max 0.4 mg/kg once daily.
Child:
Hypertension (≥6 years): Initial 8 mg once daily, max 32 mg once daily.
Adolescent:
Hypertension (≥6 years): 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., 8 mg for hypertension, 4 mg for heart failure) for CrCl <30 mL/min/1.73m².
Dialysis:
Not significantly removed by hemodialysis. Monitor closely; consider lower initial dose.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
Consider lower initial dose (e.g., 8 mg for hypertension, 4 mg for heart failure).
Severe:
Not studied; use with caution or avoid.
Pharmacology
Mechanism of Action
Candesartan cilexetil is a prodrug that is rapidly converted to the active drug, candesartan, during absorption from the gastrointestinal tract. Candesartan is a selective angiotensin II receptor blocker (ARB) that binds to the AT1 receptor, preventing angiotensin II from binding. This blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced blood pressure. It does not inhibit ACE, nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
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 hours
Clearance:
0.37 mL/min/kg
ExcretionRoute:
Renal (urine) and Biliary (feces)
Unchanged:
Approximately 26% renally excreted unchanged; 43% excreted unchanged in feces.
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-8 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected.
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 significant 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 list is not exhaustive, and you may experience other 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 significant 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 list is not exhaustive, and you may experience other 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:
- Severe dizziness or fainting spells
- Swelling of the face, lips, tongue, or throat (signs of 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 ankles/feet)
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.
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 your risk of adverse effects.
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 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.
To ensure your safety, verify that it is acceptable to take this medication with all your other medications and health conditions.
Never start, stop, or adjust the dose of any medication without consulting 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.
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 your risk of adverse effects.
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 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.
To ensure your safety, verify that it is acceptable to take this medication with all your other medications and health conditions.
Never start, stop, or adjust the dose of any medication without consulting your doctor.
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.
Follow your doctor's instructions for monitoring your blood pressure. Additionally, have your blood work and other laboratory tests checked as directed by your doctor. 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.
When taking this medication for high blood pressure, consult with your doctor before using 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.
Before consuming alcohol, talk to your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.
It is also important to 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. If you have any questions or concerns, 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.
Follow your doctor's instructions for monitoring your blood pressure. Additionally, have your blood work and other laboratory tests checked as directed by your doctor. 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.
When taking this medication for high blood pressure, consult with your doctor before using 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.
Before consuming alcohol, talk to your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.
It is also important to 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. If you have any questions or concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
If an overdose is suspected, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive, including intravenous fluid administration to correct hypotension.
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
Moderate Interactions
- ACE inhibitors (dual blockade of RAAS)
- Other antihypertensive agents (additive hypotensive effect)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN)
Rationale: To assess baseline kidney function, especially important in patients with pre-existing renal impairment or those at risk.
Timing: Prior to initiation of therapy.
Serum Electrolytes (Potassium)
Rationale: To assess baseline potassium levels due to risk of hyperkalemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments.
Target: Individualized based on patient's condition (e.g., <130/80 mmHg for most adults with hypertension).
Action Threshold: Persistent high BP (consider dose increase or add therapy); symptomatic hypotension (consider dose reduction).
Renal Function (Serum Creatinine, BUN)
Frequency: Periodically, especially with dose changes, initiation of concomitant medications (e.g., NSAIDs), or in patients with pre-existing renal impairment.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant increase in creatinine or BUN (consider dose adjustment, discontinuation, or investigation of cause).
Serum Electrolytes (Potassium)
Frequency: Periodically, especially in patients at risk for hyperkalemia (e.g., renal impairment, concomitant potassium-sparing diuretics, potassium supplements).
Target: 3.5-5.0 mEq/L.
Action Threshold: Potassium >5.5 mEq/L (consider dose adjustment, discontinuation, or management of hyperkalemia).
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Fatigue
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- Muscle weakness or cramps (signs of hyperkalemia)
- Irregular heartbeat (palpitations)
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 avoided in the first trimester. If pregnancy is detected, discontinue candesartan as soon as possible.
Trimester-Specific Risks:
First Trimester:
Limited human data, but generally advised to avoid due to potential for fetal harm. Animal studies show risk.
Second Trimester:
High risk of fetal toxicity, including oligohydramnios, fetal anuria, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
Third Trimester:
High risk of fetal toxicity, including oligohydramnios, fetal anuria, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
Lactation
It is not known whether candesartan is excreted in human milk, but it is present in rat milk. Due to the potential for serious adverse effects on the breastfed infant, breastfeeding is not recommended during candesartan therapy.
Infant Risk:
Risk unknown, but potential for serious adverse effects. L3 (Moderately Safe) is often cited, but caution and alternative agents are preferred.
Pediatric Use
Approved for hypertension in children 1 year and older. Dosing is weight-based for younger children. Not established for heart failure in pediatric patients.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is typically needed based on age alone, but monitor renal function and potassium levels closely, as these patients may be more susceptible to adverse effects.
Clinical Information
Clinical Pearls
- Candesartan cilexetil is a prodrug; the active moiety is candesartan.
- Unlike ACE inhibitors, ARBs like candesartan are less likely to cause cough, making them a suitable alternative for patients who develop cough with ACE inhibitors.
- Risk of hyperkalemia is increased, especially with concomitant use of potassium-sparing diuretics, potassium supplements, or in patients with renal impairment.
- Although less common than with ACE inhibitors, angioedema can occur with ARBs; patients should be advised to seek immediate medical attention if swelling of the face, lips, tongue, or throat occurs.
- Full antihypertensive effect may take 4-6 weeks to develop.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs) (e.g., Valsartan, Losartan, Irbesartan, Olmesartan)
- Angiotensin-Converting Enzyme (ACE) Inhibitors (e.g., Lisinopril, Enalapril, Ramipril)
- Beta-blockers (e.g., Metoprolol, Carvedilol)
- Calcium Channel Blockers (e.g., Amlodipine, Diltiazem)
- Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic 16mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 information. If you have any questions or concerns about this 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 details about the medication taken, the amount, and the time it happened.