Candesartan 32mg Tablets

Manufacturer MACLEODS PHARMACEUTICALS 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, Heart Failure Agent
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Category D (1st Trimester), Category X (2nd and 3rd Trimesters)
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 to you 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 well. Take your medication at the same time every day to establish a routine.

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

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 the 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 consistently as prescribed, preferably at the same time each day.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • Follow a low-sodium diet as recommended by your doctor or dietitian.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically advised by your doctor.
  • Monitor blood pressure at home as instructed by your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 16 mg once daily; Heart Failure: 4-8 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 (NYHA Class II-IV): Initial: 4 mg once daily; Titrate up to 32 mg once daily as tolerated (doubling dose at 2-week intervals).
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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 8 mg once daily (max 32 mg/day).
Adolescent: Hypertension (6 to <17 years): Initial 8 mg once daily (max 32 mg/day).
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Dose Adjustments

Renal Impairment:

Mild: No initial dosage adjustment needed.
Moderate: No initial dosage adjustment needed.
Severe: Consider lower initial dose (e.g., 8 mg for hypertension, 4 mg for heart failure) and careful titration. Monitor renal function and potassium closely.
Dialysis: Candesartan is not dialyzable. Consider lower initial dose and careful titration. Monitor renal function and potassium closely.

Hepatic Impairment:

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

Pharmacology

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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 blockade inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced sodium and water retention, thereby lowering blood pressure and reducing cardiac preload/afterload in heart failure.
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Pharmacokinetics

Absorption:

Bioavailability: 15% (candesartan cilexetil is a prodrug, hydrolyzed to candesartan)
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: 9-12 hours
Clearance: 0.37 mL/min/kg (renal clearance 0.19 mL/min/kg)
ExcretionRoute: Approximately 33% renal (26% unchanged, 7% as inactive metabolite) and 67% hepatic/biliary (56% unchanged, 11% as inactive metabolite).
Unchanged: Approximately 26% (renal) and 56% (biliary) of the absorbed dose.
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Pharmacodynamics

OnsetOfAction: Within 2 hours
PeakEffect: 4-6 hours (antihypertensive effect)
DurationOfAction: 24 hours

Safety & Warnings

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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.
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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.
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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 emergency medical attention)
  • Difficulty breathing or swallowing
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat, numbness or tingling)
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet, unusual tiredness)
  • If you become pregnant or suspect pregnancy, stop taking the medication and contact your doctor immediately.
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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, 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.

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 safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor to avoid potential interactions or adverse effects.
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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 drug, 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 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 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. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, focusing on maintaining blood pressure and fluid status (e.g., IV fluids).

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
  • Lithium (increased serum lithium concentrations and toxicity)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effect)
  • Diuretics (increased risk of hypotension, especially with initial doses)
  • Trimethoprim (increased risk of hyperkalemia)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

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

Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.

Timing: Prior to initiation

Serum Potassium (K+)

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

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments, then periodically (e.g., monthly, quarterly) once stable.

Target: Individualized, typically <130/80 mmHg for most adults with hypertension.

Action Threshold: If BP remains uncontrolled, consider dose increase or add-on therapy. If hypotensive, consider dose reduction.

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

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with pre-existing renal impairment or on concomitant diuretics/NSAIDs.

Target: Within patient's baseline range or acceptable limits.

Action Threshold: If SCr increases significantly (>30% from baseline or >0.5 mg/dL), consider dose reduction, discontinuation, or investigation for renal artery stenosis.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with renal impairment, diabetes, or on concomitant potassium-sparing agents.

Target: 3.5-5.0 mEq/L

Action Threshold: If K+ >5.5 mEq/L, consider dose reduction, discontinuation, or management of hyperkalemia.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing, indicating hypotension)
  • Fatigue or weakness
  • Swelling of face, lips, tongue, or throat (signs of angioedema)
  • Muscle weakness, irregular heartbeat, or numbness/tingling (signs of hyperkalemia)
  • Signs of worsening renal function (e.g., decreased urine output, swelling)

Special Patient Groups

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Pregnancy

Candesartan is contraindicated in the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. It should be discontinued as soon as pregnancy is detected. Exposure during the 1st trimester is associated with a lower, but still present, risk of major congenital malformations.

Trimester-Specific Risks:

First Trimester: Limited human data suggest a potential risk of major congenital malformations, though less severe than 2nd/3rd trimester exposure. Category D.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Category X.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Neonatal hypotension, hyperkalemia, and renal failure may occur. Category X.
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Lactation

Limited data suggest that candesartan is excreted into human milk. Due to the potential for serious adverse effects in the breastfed infant (e.g., hypotension, hyperkalemia, renal impairment), breastfeeding is generally not recommended while taking candesartan. A safer alternative should be considered.

Infant Risk: Risk level: L3 (Moderate Concern)
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Pediatric Use

Approved for hypertension in children 1 to <17 years of age. Dosing is weight-based for younger children. Close monitoring of blood pressure, renal function, and potassium is essential. Not recommended for heart failure in pediatric patients.

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Geriatric Use

No overall differences in efficacy or safety have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of candesartan, particularly regarding renal function and blood pressure. Initiate at the lower end of the dosing range and titrate carefully. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • Candesartan cilexetil is a prodrug; it is rapidly 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.
  • Always check for concomitant use of potassium-sparing diuretics, potassium supplements, or NSAIDs, as these can increase the risk of hyperkalemia and/or renal dysfunction.
  • Educate patients about the importance of avoiding pregnancy while on candesartan due to the severe fetal risks.
  • For heart failure, candesartan is typically initiated at a low dose and gradually titrated upwards to the target dose (32 mg daily) as tolerated, often in combination with a beta-blocker.
  • Patients with severe heart failure or significant renal impairment may be more susceptible to hypotension and acute kidney injury, requiring closer monitoring.
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Alternative Therapies

  • Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Olmesartan, Telmisartan, Azilsartan
  • Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril
  • Beta-blockers: Metoprolol, Carvedilol
  • Calcium Channel Blockers: Amlodipine, Nifedipine
  • Diuretics: Hydrochlorothiazide, Furosemide
  • Direct Renin Inhibitors: Aliskiren (limited use)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 32mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 information about what was taken, the amount, and the time it occurred.