Atacand 8mg 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, Heart Failure Agent
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Category D (2nd and 3rd trimesters), Category C (1st trimester) - Note: FDA has moved to a risk summary approach, but this classification is still widely referenced for ARBs due to the significant risk.
FDA Approved
Aug 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 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.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. It's essential to continue taking this 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, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, be sure to shake it well before each use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable device to ensure accurate measurements.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep the lid tightly closed. If a liquid suspension is made 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 your medication exactly as prescribed, usually once daily, with or without food.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Monitor your blood pressure regularly at home as advised by your doctor.
  • Limit your intake of high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens) and avoid potassium supplements or salt substitutes containing potassium, unless specifically instructed by your doctor.
  • Maintain a healthy diet low in sodium and saturated fats.
  • Engage in regular physical activity as recommended by your doctor.
  • Limit alcohol consumption.
  • 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: Initial 16 mg once daily. Heart Failure: Initial 4 mg once daily.
Dose Range: 4 - 32 mg

Condition-Specific Dosing:

Hypertension: Initial 16 mg once daily; usual maintenance 8-32 mg once daily. Max 32 mg/day.
Heart Failure: Initial 4 mg once daily, titrate to target dose of 32 mg once daily as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for infants <1 year. For children 1 to <6 years: Initial 0.2 mg/kg once daily (max 16 mg/day).
Child: For children 6 to <17 years: Initial 8 mg once daily for patients weighing <50 kg; 16 mg once daily for patients weighing ≥50 kg. Max 32 mg/day.
Adolescent: Initial 16 mg once daily; usual maintenance 8-32 mg once daily. Max 32 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment needed.
Moderate: No initial dose adjustment needed.
Severe: Consider lower initial dose (e.g., 8 mg once daily for hypertension, 4 mg once daily for heart failure) for patients with severe renal impairment (CrCl <30 mL/min/1.73 m²).
Dialysis: Candesartan is not removed by hemodialysis. No specific dose adjustment for patients on dialysis, but monitor closely.

Hepatic Impairment:

Mild: No initial dose adjustment needed.
Moderate: Consider lower initial dose (e.g., 8 mg once daily for hypertension, 4 mg once daily for heart failure) for patients with moderate hepatic impairment. Use with caution.
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, the active drug, 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. It also reduces cardiac remodeling and fibrosis in heart failure.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 15% (of candesartan cilexetil)
Tmax: 3-4 hours
FoodEffect: Food does not affect the bioavailability of candesartan.

Distribution:

Vd: 0.13 L/kg
ProteinBinding: >99% (primarily to plasma albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 9-10 hours
Clearance: Not readily available as a single value, but renal clearance is approximately 0.19 L/hr/kg.
ExcretionRoute: Approximately 33% renally excreted and 67% excreted via bile/feces.
Unchanged: Approximately 26% of an oral dose is excreted unchanged in urine.
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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

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (signs of low blood pressure)
  • Swelling of the face, lips, tongue, or throat (angioedema - seek immediate medical attention)
  • Difficulty breathing or swallowing (angioedema - seek immediate medical attention)
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles or feet, unusual tiredness)
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, especially if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are breast-feeding, as this medication is not recommended for nursing mothers. 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 approved for use in infants younger than 1 year.

Additional Precautions:

This medication may interact with other drugs, including prescription and over-the-counter medications, natural products, and vitamins. Provide your doctor and pharmacist with a comprehensive list of all your medications and health conditions to ensure safe treatment.
* Do not start, stop, or change the dose of any medication without consulting your doctor, as this may affect the safety and efficacy of your treatment.
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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.

Regularly check your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests monitored.

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.

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 with 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, an additional medication may be necessary. If you have any questions or concerns, discuss them with your doctor.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Dizziness
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate, less common)

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic. Lay the patient supine with legs elevated. Intravenous fluids may be administered to correct hypotension.

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) - increased risk of hyperkalemia
  • Potassium supplements - increased risk of hyperkalemia
  • NSAIDs (Nonsteroidal Anti-inflammatory Drugs, including COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment (especially in elderly, volume-depleted, or renally impaired patients)
  • Lithium - increased serum lithium concentrations and lithium toxicity
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Moderate Interactions

  • ACE inhibitors (e.g., enalapril, lisinopril) - increased risk of hypotension, hyperkalemia, and renal impairment (dual blockade generally not recommended)
  • Other antihypertensives - additive hypotensive effect
  • Trimethoprim/sulfamethoxazole (Bactrim) - 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 and are renally eliminated.

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: <130/80 mmHg (general target, individualized based on patient comorbidities)

Action Threshold: Persistent BP above target, or symptomatic hypotension.

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

Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Stable or minor fluctuations from baseline.

Action Threshold: Significant increase in SCr (>30% from baseline or >0.5 mg/dL), especially if accompanied by symptoms of renal dysfunction.

Serum Potassium (K+)

Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially if on concomitant medications that increase K+.

Target: 3.5-5.0 mEq/L

Action Threshold: K+ >5.5 mEq/L (consider dose reduction or discontinuation), or symptomatic hyperkalemia.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
  • Fatigue or weakness
  • Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
  • Difficulty breathing or swallowing (angioedema)
  • Muscle cramps or weakness, irregular heartbeat (symptoms of hyperkalemia)
  • Signs of worsening renal function (e.g., decreased urine output, edema)

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 may also carry risks. If pregnancy is detected, discontinue candesartan as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies suggest potential for adverse effects. Considered Category C.
Second Trimester: High risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal death. Considered Category D.
Third Trimester: High risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal death. Considered Category D.
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Lactation

It is not known whether candesartan is excreted in human milk. Due to the potential for adverse effects on the nursing 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. Caution is advised.

Infant Risk: Potential for serious adverse reactions in the breastfed infant (e.g., hypotension, hyperkalemia, renal impairment). Risk is generally considered low for healthy, full-term infants, but caution is warranted.
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Pediatric Use

Approved for hypertension in children 1 to <17 years. Dosing is weight-based for younger children. Safety and efficacy have not been established in children less than 1 year of age. Close monitoring of blood pressure, renal function, and potassium is essential.

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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. No specific dose adjustment is required based on age alone, but consider starting at the lower end of the dosing range and monitor renal function more closely, as elderly patients are more likely to have decreased renal function.

Clinical Information

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Clinical Pearls

  • Candesartan cilexetil is a prodrug; it is converted to the active drug candesartan in the GI tract.
  • It is generally well-tolerated and a good alternative for patients who develop a cough with ACE inhibitors.
  • Once-daily dosing promotes patient adherence.
  • Monitor for hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics or potassium supplements.
  • Angioedema is a rare but serious side effect; educate patients on symptoms and to seek immediate medical attention if it occurs.
  • Not recommended for use in combination with ACE inhibitors for most patients due to increased risk of adverse events without significant additional benefit.
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Alternative Therapies

  • Other Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, Irbesartan, Telmisartan, Olmesartan, Azilsartan
  • ACE Inhibitors (e.g., Lisinopril, Enalapril, Ramipril)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine, Diltiazem)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • 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), Tier 3 or higher (for brand)
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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 your 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 medication taken, the amount, and the time it occurred.