Atacand 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, Heart Failure Agent
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D (2nd and 3rd trimesters), Category C (1st trimester) - now generally contraindicated in 2nd/3rd trimesters due to fetal toxicity
FDA Approved
Aug 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 belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels, which helps lower blood pressure and makes it easier for your heart to pump blood.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions 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 directed by your doctor or healthcare provider, even if you start to feel better. To establish a routine, take your medication at the same time every day.
If you have trouble 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
Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed to maintain the medication's effectiveness. If a liquid suspension is prepared 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 and 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, follow your doctor's instructions 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 directed by your doctor or healthcare provider, even if you start to feel better. To establish a routine, take your medication at the same time every day.
If you have trouble 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
Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed to maintain the medication's effectiveness. If a liquid suspension is prepared 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 and 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 the 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 if advised by your doctor.
- Limit sodium intake as advised 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 diet, regular exercise, and limit alcohol consumption as part of a comprehensive treatment plan for hypertension or heart failure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 8-32 mg once daily; Heart Failure: Initial 4 mg once daily, target 32 mg once daily
Dose Range:
4 - 32 mg
Condition-Specific Dosing:
hypertension:
Initial 4-16 mg once daily, maintenance 8-32 mg once daily. Max 32 mg/day.
heartFailure:
Initial 4 mg once daily, titrate up to 32 mg once daily as tolerated.
Pediatric Dosing
Neonatal:
Not established (contraindicated in infants <1 year due to potential effects on kidney development)
Infant:
Not established (contraindicated in infants <1 year)
Child:
Hypertension (1 to <6 years): Initial 0.2 mg/kg once daily (max 0.4 mg/kg); Hypertension (6 to <17 years): Initial 4-8 mg once daily (max 32 mg/day).
Adolescent:
Hypertension (6 to <17 years): Initial 4-8 mg once daily (max 32 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment needed, monitor renal function.
Moderate:
Consider lower initial dose (e.g., 4 mg) for hypertension. Monitor renal function and potassium closely.
Severe:
Consider lower initial dose (e.g., 4 mg) for hypertension. Monitor renal function and potassium closely. Use with caution.
Dialysis:
Candesartan is not dialyzable. Consider lower initial dose (e.g., 4 mg) and monitor closely.
Hepatic Impairment:
Mild:
No initial dose adjustment needed.
Moderate:
Consider lower initial dose (e.g., 4 mg) for hypertension. Monitor closely.
Severe:
Not studied. Use with caution, if at all, and monitor closely.
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 competitive antagonist of the angiotensin II type 1 (AT1) receptor. It blocks the binding of angiotensin II to the AT1 receptor, thereby inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. This leads to vasodilation, decreased peripheral vascular resistance, and reduced blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
15% (of candesartan cilexetil)
Tmax:
3-4 hours
FoodEffect:
No clinically significant effect on absorption.
Distribution:
Vd:
0.13 L/kg
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
9 hours
Clearance:
Not available (plasma clearance approximately 0.37 mL/min/kg)
ExcretionRoute:
Renal (approximately 33%) and biliary/fecal (approximately 67%)
Unchanged:
Approximately 26% renally, 43% fecally
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-8 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue Atacand 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 or seek immediate 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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, 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 or seek immediate 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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)
- Unusual swelling of the face, lips, tongue, or throat (signs of angioedema – seek emergency medical attention)
- Difficulty breathing or swallowing
- Signs of high potassium (e.g., muscle weakness, irregular heartbeat, numbness or tingling)
- Signs of kidney problems (e.g., decreased urine, swelling in feet/ankles, unusual tiredness)
- If you become pregnant, stop taking this medication immediately and contact your doctor.
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, and 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 have either diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are breast-feeding, as you should not breast-feed 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 infants 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 to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor to avoid potential interactions or adverse effects.
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, and 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 have either diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are breast-feeding, as you should not breast-feed 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 infants 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 to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor to avoid potential interactions or adverse effects.
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 monitor your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests checked.
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.
If you are on a low-sodium or sodium-free diet, discuss this with your doctor. When taking this medication for high blood pressure, consult 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 avoid 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 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.
Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests checked.
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.
If you are on a low-sodium or sodium-free diet, discuss this with your doctor. When taking this medication for high blood pressure, consult 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 avoid 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 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 (low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
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. Lay the patient supine with legs elevated. Intravenous fluids may be administered for hypotension. Candesartan is not removed by hemodialysis.
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)
- Lithium
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effect)
- ACE inhibitors (dual blockade of the renin-angiotensin system, increased risk of hyperkalemia, hypotension, and renal impairment)
- Trimethoprim/sulfamethoxazole (increased risk of hyperkalemia)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum Creatinine and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect kidney function, especially in patients with pre-existing renal impairment or heart failure.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia, particularly in patients with renal impairment or those taking potassium-sparing diuretics or supplements.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments, until stable. Then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: <130/80 mmHg (general target, may vary based on patient comorbidities)
Action Threshold: Persistent hypertension despite maximum dose, or symptomatic hypotension.
Serum Creatinine and BUN
Frequency: Periodically, especially after dose changes, initiation of concomitant medications (e.g., NSAIDs), or in patients with renal impairment or heart failure (e.g., every 1-3 months initially, then every 6-12 months).
Target: Within normal limits or stable from baseline.
Action Threshold: Significant increase (e.g., >30% above baseline or >2.5 mg/dL) or signs of acute kidney injury; consider dose reduction or discontinuation.
Serum Potassium
Frequency: Periodically, especially after dose changes, initiation of concomitant medications (e.g., potassium-sparing diuretics, potassium supplements), or in patients with renal impairment or heart failure (e.g., every 1-3 months initially, then every 6-12 months).
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L; consider dose reduction, discontinuation, or management of hyperkalemia.
Symptom Monitoring
- Dizziness or lightheadedness (signs of hypotension)
- Fatigue or weakness
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing (signs of angioedema)
- Muscle weakness, irregular heartbeat, or numbness/tingling (signs of hyperkalemia)
- Decreased urine output (signs of worsening renal function)
Special Patient Groups
Pregnancy
Contraindicated in the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Not recommended in the first trimester. If pregnancy is detected, discontinue as soon as possible.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not recommended due to potential risk. Category C.
Second Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
Third Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
Lactation
Not recommended during breastfeeding. It is unknown if candesartan is excreted in human milk. Due to the potential for serious adverse effects on 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:
Potential for serious adverse effects (e.g., hypotension, renal effects) in the breastfed infant. Risk is considered L3 (Moderately Safe) or L4 (Possibly Hazardous) by some sources, but generally advised against.
Pediatric Use
Contraindicated in infants less than 1 year of age due to potential adverse effects on developing kidneys. For children 1 to <17 years with hypertension, specific dosing guidelines exist, but use requires careful monitoring of blood pressure, renal function, and potassium.
Geriatric Use
No overall difference in efficacy or safety has been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is generally not needed based on age alone, but monitor renal function more closely as it may be impaired in elderly patients.
Clinical Information
Clinical Pearls
- Candesartan cilexetil is a prodrug that is converted to the active drug candesartan in the GI tract.
- It is a good alternative for patients who develop a cough with ACE inhibitors, as ARBs do not inhibit bradykinin breakdown.
- Monitor serum potassium and renal function (creatinine, BUN) regularly, especially in patients with pre-existing renal impairment, heart failure, or those on concomitant medications that affect potassium or renal function.
- The full antihypertensive effect may take 4-6 weeks to develop.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but serious side effect.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Olmesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
- Beta-blockers: Metoprolol, Atenolol, Carvedilol
- Other antihypertensive classes depending on patient comorbidities.
Cost & Coverage
Average Cost:
Not available (varies widely by pharmacy and location) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic), Tier 3 or 4 (for brand)
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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.