Atacand 32mg Tablets

Manufacturer ASTRA ZENECA Active Ingredient Candesartan(kan de SAR tan) Pronunciation kan de SAR tan
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.
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Drug Class
Antihypertensive, Agent for Heart Failure
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Category D (2nd/3rd trimester), Category X (1st trimester - generally contraindicated)
FDA Approved
Jun 1998
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DEA Schedule
Not Controlled

Overview

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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. For heart failure, it helps the heart pump blood more efficiently.
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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. Take your medication at the same time every day to establish a routine.

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 place, 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.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily, with or without food.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • Monitor your blood pressure regularly at home if advised by your doctor.
  • Limit alcohol intake as it can further lower blood pressure.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Maintain a healthy diet (low sodium), regular exercise, and manage stress to support blood pressure control.
  • Inform your doctor or dentist that you are taking candesartan before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 16 mg once daily; Heart Failure: 4-8 mg once daily, titrated up to 32 mg once daily
Dose Range: 4 - 32 mg

Condition-Specific Dosing:

Hypertension: Initial dose 16 mg once daily; usual maintenance 8-32 mg once daily. Max 32 mg/day.
Heart Failure: Initial dose 4 mg once daily, doubled at 2-week intervals, as tolerated, to a target dose of 32 mg once daily.
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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).
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment needed.
Moderate: Consider lower initial dose (e.g., 8 mg for hypertension, 4 mg for heart failure). Titrate cautiously.
Severe: Consider lower initial dose (e.g., 8 mg for hypertension, 4 mg for heart failure). Titrate cautiously. Monitor renal function and potassium closely.
Dialysis: Not removed by hemodialysis. Consider lower initial dose and titrate cautiously. Monitor renal function and potassium closely.

Hepatic Impairment:

Mild: No initial dose adjustment needed.
Moderate: Consider lower initial dose (e.g., 8 mg for hypertension, 4 mg for heart failure). Titrate cautiously. Monitor closely.
Severe: Not recommended due to lack of data.

Pharmacology

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Mechanism of Action

Candesartan cilexetil is a prodrug that is rapidly and completely hydrolyzed to 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.
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Pharmacokinetics

Absorption:

Bioavailability: 15% (candesartan cilexetil prodrug)
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: Approximately 33% renally (26% as unchanged candesartan, 7% as inactive metabolite) and 67% hepatobiliary (56% as unchanged candesartan, 11% as inactive metabolite).
Unchanged: Approximately 26% (renal), 56% (biliary)
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Pharmacodynamics

OnsetOfAction: Within 2 hours
PeakEffect: 4-6 hours
DurationOfAction: 24 hours

Safety & Warnings

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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.
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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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Swelling of the face, lips, tongue, or throat (signs of angioedema - seek immediate medical attention)
  • Difficulty breathing or swallowing
  • Unusual tiredness or weakness
  • Muscle cramps or weakness
  • Irregular heartbeat
  • Signs of kidney problems (e.g., decreased urination, swelling in feet/ankles)
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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 due to 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 breast-feed while taking this medication.

Special Considerations for Children:

If your child is under 1 year of age, do not give them 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.
You must verify that it is safe to take this medication with all your other medications and health conditions.
Do not start, stop, or change the dose of any medication without consulting your doctor first.
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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 supplement, consult with your doctor. Similarly, 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 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.
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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 to correct hypotension. Hemodialysis is not effective in removing candesartan.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or moderate to severe renal impairment [GFR <60 mL/min/1.73 m²])
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • Salt substitutes containing potassium
  • NSAIDs (including selective COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment and hyperkalemia
  • Lithium (increased serum lithium concentrations and toxicity)
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Moderate Interactions

  • Other antihypertensive agents (additive hypotensive effect)
  • Diuretics (increased risk of hypotension, especially first-dose hypotension)
  • Trimethoprim (increased risk of hyperkalemia)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Rationale: To assess baseline renal function, especially important in patients with pre-existing renal impairment or heart failure.

Timing: Prior to initiation of therapy.

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Individualized based on treatment guidelines (e.g., <130/80 mmHg for most adults).

Action Threshold: Persistent high BP (consider dose increase or add therapy); symptomatic hypotension (consider dose reduction).

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Frequency: Periodically, especially after dose changes, in patients with renal impairment, or those on concomitant diuretics/NSAIDs.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant increase (e.g., >30% from baseline or acute kidney injury symptoms) - consider dose reduction or discontinuation.

Serum Potassium (K+)

Frequency: Periodically, especially after dose changes, in patients with renal impairment, heart failure, or those on concomitant potassium-sparing agents.

Target: 3.5-5.0 mEq/L.

Action Threshold: K+ >5.5 mEq/L - consider dose reduction or discontinuation; K+ >6.0 mEq/L - urgent intervention.

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Symptom Monitoring

  • Dizziness or lightheadedness (signs of hypotension)
  • Swelling of face, lips, tongue, or throat (signs of angioedema)
  • Muscle weakness, fatigue, irregular heartbeats (signs of hyperkalemia)
  • Decreased urine output, swelling in ankles/feet (signs of worsening renal function)

Special Patient Groups

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Pregnancy

Candesartan is contraindicated in pregnancy, especially during the second and third trimesters, due to the risk of fetal injury and death. Exposure during the first trimester should also be avoided if possible.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal data suggest potential for teratogenicity. Generally, ARBs should be avoided if possible, and alternative antihypertensive therapy should be considered if pregnancy is planned or detected.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Neonatal hypotension, hyperkalemia, and renal failure may also occur.
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Lactation

Not recommended during breastfeeding. Candesartan is excreted into the milk of lactating rats, and there is a potential for serious adverse effects in the nursing infant.

Infant Risk: Potential for serious adverse reactions in the breastfed infant (e.g., hypotension, renal effects). Risk is considered moderate (L3).
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Pediatric Use

Approved for hypertension in children 1 to <17 years of age. Dosing is weight-based for younger children. Safety and efficacy for heart failure in pediatric patients have not been established. Close monitoring of renal function and potassium is crucial.

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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. Start with lower doses and titrate cautiously, monitoring renal function and potassium closely due to higher likelihood of impaired renal function.

Clinical Information

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Clinical Pearls

  • Candesartan is a prodrug; the active compound is candesartan.
  • Unlike ACE inhibitors, ARBs like candesartan do not cause cough as a common side effect, making them a good alternative for patients who develop ACE inhibitor-induced cough.
  • Risk of hyperkalemia is increased when co-administered with potassium-sparing diuretics, potassium supplements, or NSAIDs. Monitor serum potassium closely.
  • First-dose hypotension can occur, especially in volume-depleted patients (e.g., those on high-dose diuretics). Consider reducing diuretic dose or initiating candesartan at a lower dose.
  • Angioedema is a rare but serious side effect; patients should be advised to seek immediate medical attention if swelling of the face, lips, tongue, or throat occurs.
  • Patients with severe heart failure whose renal function is dependent on the activity of the renin-angiotensin-aldosterone system may be at risk of oliguria and/or progressive azotemia, and rarely, acute renal failure and/or death.
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Alternative Therapies

  • ACE inhibitors (e.g., Lisinopril, Enalapril)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
  • Thiazide diuretics (e.g., Hydrochlorothiazide)
  • Loop diuretics (e.g., Furosemide - for heart failure)
  • Direct Renin Inhibitors (e.g., Aliskiren - limited use)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for generic 30 tablets per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.