Atacand 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, 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 attack, stroke, and kidney problems.
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, be sure to shake it well before each use. When measuring a liquid dose, 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, be sure to shake it well before each use. When measuring a liquid dose, 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 medication exactly as prescribed, usually once daily.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Monitor blood pressure regularly at home if advised by your doctor.
- Maintain a healthy lifestyle: balanced diet (low in sodium), regular exercise, limit alcohol, and avoid smoking.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 16 mg once daily; Heart Failure: Initial 4 mg once daily, titrate to target 32 mg once daily
Dose Range:
4 - 32 mg
Condition-Specific Dosing:
hypertension:
Initial 16 mg once daily, may be increased to 32 mg once daily if needed.
heartFailure:
Initial 4 mg once daily, double dose at 2-week intervals, as tolerated, to target 32 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (1 to <6 years): Initial 0.2 mg/kg once daily (max 16 mg/day); 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 dosage adjustment needed.
Moderate:
No initial dosage adjustment needed.
Severe:
Consider lower initial dose (e.g., 4 mg) in patients with severe renal impairment (CrCl <30 mL/min/1.73 m²).
Dialysis:
Not removed by hemodialysis. Consider lower initial dose (e.g., 4 mg) in patients on dialysis.
Hepatic Impairment:
Mild:
No initial dosage adjustment needed.
Moderate:
Consider lower initial dose (e.g., 4 mg) in patients with moderate hepatic impairment.
Severe:
Not recommended in severe hepatic impairment due to lack of data.
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 an angiotensin II receptor blocker (ARB) that selectively 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, nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Pharmacokinetics
Absorption:
Bioavailability:
15% (candesartan cilexetil)
Tmax:
3-4 hours
FoodEffect:
Food does not affect the bioavailability of candesartan.
Distribution:
Vd:
0.13 L/kg
ProteinBinding:
Greater than 99%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 9 hours
Clearance:
Not available
ExcretionRoute:
Renal (26%) and biliary/fecal (71%)
Unchanged:
Approximately 33% (renal), 67% (biliary/fecal)
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-6 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 Attention Immediately
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 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 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 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 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 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 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:
- Severe dizziness or fainting (signs of low blood pressure)
- Swelling of the face, lips, tongue, or throat (signs of angioedema, though rare)
- 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, 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, such as foods or medications. 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 the risk of adverse effects.
If you are breast-feeding, as you should not take this medication while nursing.
Additionally, consider the following age-related guidelines:
* 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.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or modify 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, such as foods or medications. 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 the risk of adverse effects.
If you are breast-feeding, as you should not take this medication while nursing.
Additionally, consider the following age-related guidelines:
* 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.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or modify 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.
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 supplement, 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, 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 mindful of fluid loss and drink plenty of fluids. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.
It's 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 to achieve the desired effect. If you have any questions or concerns, 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 supplement, 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, 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 mindful of fluid loss and drink plenty of fluids. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.
It's 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 to achieve the desired effect. If you have any questions or concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Hypotension (low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Administer IV fluids to support blood pressure. Candesartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Lithium
- NSAIDs (including selective COX-2 inhibitors)
Moderate Interactions
- ACE inhibitors (increased risk of hyperkalemia, hypotension, renal impairment)
- Diuretics (increased risk of hypotension)
- Other antihypertensives (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
Serum Creatinine (SCr)
Rationale: To assess baseline renal function, as ARBs can affect renal perfusion.
Timing: Prior to initiation
Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation
Serum Potassium (K+)
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, may vary by patient)
Action Threshold: Persistent high BP (consider dose increase/add-on therapy); symptomatic hypotension (consider dose reduction/discontinuation)
Serum Creatinine (SCr) and BUN
Frequency: Periodically, especially after dose adjustments or in patients with renal impairment or on diuretics
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase (e.g., >30% from baseline) or acute kidney injury (consider dose reduction/discontinuation, investigate cause)
Serum Potassium (K+)
Frequency: Periodically, especially in patients with renal impairment, diabetes, or on potassium-sparing diuretics/supplements
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L (consider dose reduction/discontinuation, manage hyperkalemia)
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Swelling (angioedema, though rare with ARBs)
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
- Signs of worsening renal function (e.g., decreased urine output)
Special Patient Groups
Pregnancy
Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. First trimester exposure may also carry risk.
Trimester-Specific Risks:
First Trimester:
Limited human data, but potential risk cannot be excluded. Animal studies show risk. Generally, avoid if possible.
Second Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and fetal death.
Third Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and fetal death.
Lactation
Limited data. Candesartan is excreted into the milk of lactating rats. 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:
Risk cannot be excluded. Potential for hypotension, hyperkalemia, and renal effects in the infant.
Pediatric Use
Approved for hypertension in children 1 to <17 years. Dosing is weight-based for younger children. Safety and efficacy for heart failure in pediatric patients have not been established.
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 dosage adjustment is generally needed based solely on age, but consider age-related decline in renal function.
Clinical Information
Clinical Pearls
- Candesartan cilexetil is a prodrug; the active drug is candesartan.
- Unlike ACE inhibitors, ARBs like candesartan are less likely to cause cough, making them a good alternative for patients who develop ACE inhibitor-induced cough.
- Monitor potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements, due to the risk of hyperkalemia.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is rare with ARBs.
- Always check for pregnancy status before initiating or continuing candesartan in women of childbearing potential due to the severe fetal toxicity risk.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Olmesartan, Irbesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
- Diuretics: Hydrochlorothiazide, Chlorthalidone, Furosemide
- Direct Renin Inhibitors: Aliskiren (limited use)
Cost & Coverage
Average Cost:
Not available per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.