Atacand HCT 32-25mg Tablets

Manufacturer ANI Active Ingredient Candesartan and Hydrochlorothiazide(kan de SAR tan & hye droe klor oh THYE a zide) Pronunciation KAN-de-SAR-tan & HYE-droe-KLOR-oh-THYE-a-zide
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.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB) and Thiazide Diuretic Combination
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Pregnancy Category
Not available (Old categories are being phased out. Contraindicated in 2nd and 3rd trimesters. See Black Box Warning and Special Populations for detailed risk.)
FDA Approved
Apr 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Atacand HCT is a combination medicine used to treat high blood pressure (hypertension). It contains two active ingredients: candesartan, which helps relax blood vessels, and hydrochlorothiazide, which helps your body get rid of extra salt and water. Together, they help lower your blood pressure, reducing the risk of heart attack and stroke.
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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 the medication as directed by your doctor or healthcare provider, even if you start to feel better.

It's essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. Be aware that this medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking the medication too close to bedtime.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.

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 to make up for the missed one.
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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.
  • Limit sodium (salt) intake in your diet as advised by your doctor or dietitian.
  • Engage in regular physical activity (e.g., walking, cycling) as recommended by your doctor.
  • Maintain a healthy weight.
  • Limit alcohol consumption.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
  • Stay hydrated, especially during exercise or hot weather, but avoid excessive fluid intake unless advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose is typically Candesartan 16 mg/Hydrochlorothiazide 12.5 mg once daily. The 32 mg/25 mg strength is for patients who require further blood pressure reduction after initial therapy or who are already on these doses separately.
Dose Range: 16 - 32 mg

Condition-Specific Dosing:

Hypertension: Initial dose: Candesartan 16 mg/Hydrochlorothiazide 12.5 mg once daily. May be titrated up to Candesartan 32 mg/Hydrochlorothiazide 25 mg once daily if needed for blood pressure control. The 32-25mg strength is a maximum dose combination.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment required (CrCl > 50 mL/min).
Moderate: Use with caution. Not recommended as initial therapy. For patients already on candesartan, consider lower doses or alternative therapy if CrCl is 30-50 mL/min. Hydrochlorothiazide becomes less effective below CrCl 30 mL/min.
Severe: Contraindicated (CrCl < 30 mL/min) due to hydrochlorothiazide component.
Dialysis: Not recommended. Candesartan is not dialyzable. Hydrochlorothiazide is not effectively removed by dialysis.

Hepatic Impairment:

Mild: No initial dose adjustment required.
Moderate: Use with caution. Candesartan exposure may be increased. Hydrochlorothiazide should be used with caution in severe hepatic impairment as it may precipitate hepatic coma.
Severe: Not recommended.

Pharmacology

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Mechanism of Action

Candesartan is an angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic. It acts on the distal convoluted tubule of the kidney to inhibit the reabsorption of sodium and chloride ions. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and blood pressure.
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Pharmacokinetics

Absorption:

Bioavailability: Candesartan: 15% (candesartan cilexetil is a prodrug, 100% converted to candesartan). Hydrochlorothiazide: 50-80%.
Tmax: Candesartan: 3-4 hours. Hydrochlorothiazide: 1-2.5 hours.
FoodEffect: Candesartan: Food does not affect bioavailability. Hydrochlorothiazide: Food may increase absorption slightly but is not clinically significant.

Distribution:

Vd: Candesartan: 0.13 L/kg. Hydrochlorothiazide: 0.8-1.7 L/kg.
ProteinBinding: Candesartan: >99%. Hydrochlorothiazide: 40-68%.
CnssPenetration: Candesartan: Limited. Hydrochlorothiazide: Limited.

Elimination:

HalfLife: Candesartan: 9-12 hours. Hydrochlorothiazide: 5.6-14.8 hours.
Clearance: Candesartan: 0.37 mL/min/kg. Hydrochlorothiazide: 2.5-3.0 mL/min/kg.
ExcretionRoute: Candesartan: Primarily renal (33%) and biliary/fecal (67%). Hydrochlorothiazide: Primarily renal (95% unchanged).
Unchanged: Candesartan: Approximately 26% (renal). Hydrochlorothiazide: Approximately 95% (renal).
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Pharmacodynamics

OnsetOfAction: Candesartan: Within 2 hours. Hydrochlorothiazide: Within 2 hours.
PeakEffect: Candesartan: 4-8 hours. Hydrochlorothiazide: 4-6 hours.
DurationOfAction: Candesartan: 24 hours. Hydrochlorothiazide: 6-12 hours.

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Atacand HCT 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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Change in urine output or dry mouth
+ Dry eyes or severe stomach upset or vomiting
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn or muscle and joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Eye problems, which can lead to permanent vision loss if left untreated. If you experience:
+ Changes in vision or eye pain, contact your doctor immediately (these symptoms usually occur within hours to weeks of starting the medication)
Rarely, skin cancer has been reported in people taking hydrochlorothiazide. To minimize your risk:
+ Protect your skin from the sun
+ Follow your doctor's instructions for skin checks
+ Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Signs of a common cold
Back pain
Flu-like symptoms
* Dizziness

This is not an exhaustive list of possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Unusual tiredness or weakness
  • Muscle cramps or pain
  • Irregular heartbeat
  • Swelling of the face, lips, tongue, or throat (signs of angioedema - seek emergency medical attention)
  • Difficulty breathing or swallowing
  • Decreased urination or swelling in your feet/ankles (signs of kidney problems)
  • Yellowing of skin or eyes (jaundice)
  • Severe skin rash or blistering
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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 known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A confirmed sulfa allergy.
Current treatment with dofetilide.
Difficulty urinating or inability to pass urine.
Pre-existing kidney disease.
Elevated calcium levels.
Concurrent use of a medication containing aliskiren, especially if you have diabetes or kidney problems.
Breast-feeding or plans to breast-feed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage 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, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position and be careful when climbing stairs.

If you have diabetes, this medication may cause an increase in blood sugar levels. Discuss with your doctor how to maintain control over your blood sugar levels. Regularly check your blood pressure as advised by your doctor, and undergo blood tests and other laboratory tests as recommended.

This medication may lead to increased cholesterol and triglyceride levels. Consult your doctor about this potential effect. Additionally, this medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with 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, or certain natural products or aids, consult your doctor.

Exercise caution when consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may slow your reactions. Discuss these substances with your doctor before use.

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.

If you are taking cholestyramine or colestipol, consult your pharmacist about the best way to take these medications with this drug. Be aware of the potential for gout attacks.

For individuals with lupus, this medication may reactivate or worsen the condition. Immediately report any new or worsening symptoms to your doctor. It may take approximately one month to experience the full effects of this medication.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Dizziness, lightheadedness, fainting
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)
  • Electrolyte imbalances (e.g., hypokalemia, hyponatremia)
  • Dehydration
  • Nausea, vomiting

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Induce emesis or perform gastric lavage if ingestion is recent. Administer activated charcoal. Monitor vital signs, fluid and electrolyte balance, and renal function closely.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Potassium supplements or potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) due to increased risk of hyperkalemia
  • Lithium (increased lithium levels and toxicity)
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Major Interactions

  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib): May reduce antihypertensive effect and increase risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
  • Other antihypertensives (e.g., ACE inhibitors, beta-blockers, calcium channel blockers): Additive hypotensive effects.
  • Digoxin: Thiazides can increase digoxin toxicity due to hypokalemia.
  • Corticosteroids: May enhance electrolyte depletion, particularly hypokalemia.
  • Cholestyramine and colestipol resins: May impair absorption of hydrochlorothiazide.
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Moderate Interactions

  • Antidiabetic agents (oral agents and insulin): Thiazides may decrease glucose tolerance, requiring adjustment of antidiabetic dosage.
  • Pressor amines (e.g., norepinephrine): May decrease arterial responsiveness to pressor amines.
  • Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine): May potentiate the effect of muscle relaxants.
  • Allopurinol: Increased risk of hypersensitivity reactions to allopurinol.
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Minor Interactions

  • Alcohol, barbiturates, or narcotics: May potentiate orthostatic hypotension.
  • Calcium salts: Increased serum calcium levels due to decreased excretion.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy of treatment.

Timing: Prior to initiation of therapy

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To establish baseline and identify pre-existing imbalances, especially potassium due to diuretic effect and ARB effect.

Timing: Prior to initiation of therapy

Renal Function (Serum Creatinine, BUN, eGFR)

Rationale: To assess baseline kidney function, as both components are renally cleared and can affect renal function.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, as candesartan is metabolized by the liver and HCTZ can affect liver function in severe impairment.

Timing: Prior to initiation of therapy

Serum Uric Acid

Rationale: Hydrochlorothiazide can increase uric acid levels.

Timing: Prior to initiation of therapy

Fasting Blood Glucose

Rationale: Hydrochlorothiazide can affect glucose metabolism.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly/quarterly once stable

Target: <130/80 mmHg (individualized based on guidelines and patient comorbidities)

Action Threshold: If BP remains uncontrolled, consider dose titration or additional therapy. If hypotensive, reduce dose.

Serum Electrolytes (Potassium, Sodium)

Frequency: 1-2 weeks after initiation/dose change, then every 3-6 months or as clinically indicated

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L

Action Threshold: Potassium < 3.5 mEq/L or > 5.5 mEq/L; Sodium < 130 mEq/L or > 150 mEq/L. Address imbalances promptly.

Renal Function (Serum Creatinine, eGFR)

Frequency: 1-2 weeks after initiation/dose change, then every 3-6 months or as clinically indicated

Target: Stable creatinine, eGFR > 60 mL/min/1.73m² (or stable for patient's baseline)

Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR. Consider dose adjustment or discontinuation.

Serum Uric Acid

Frequency: Annually or as clinically indicated, especially if patient has history of gout

Target: Within normal limits

Action Threshold: Elevated levels, especially if symptomatic (gout flares).

Blood Glucose

Frequency: Annually or as clinically indicated, especially in diabetic patients

Target: Within target range for patient

Action Threshold: Significant hyperglycemia.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Excessive fatigue or weakness
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Dry mouth, increased thirst (signs of dehydration)
  • Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
  • Persistent cough (less common with ARBs than ACEIs, but possible)
  • Signs of gout (joint pain, swelling)
  • Unusual bleeding or bruising (rare, due to HCTZ effect on platelets)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is also associated with potential risks.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies suggest potential for fetal harm. Risk of major congenital malformations cannot be ruled out.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Increased risk of fetal renal dysfunction, oligohydramnios, anuria, hypotension, hyperkalemia, and skull hypoplasia. Neonatal renal failure and death have been reported.
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Lactation

Not recommended during breastfeeding. Both candesartan and hydrochlorothiazide are excreted in breast milk. Due to the potential for serious adverse effects in the breastfed infant (e.g., hypotension, electrolyte disturbances), 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 hypotension, hyperkalemia (from candesartan), and electrolyte disturbances (from HCTZ). May also suppress lactation.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

No overall differences in effectiveness 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 carefully, monitoring renal function and electrolytes more frequently due to increased susceptibility to adverse effects (e.g., dehydration, electrolyte imbalances, renal impairment).

Clinical Information

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Clinical Pearls

  • Atacand HCT is a fixed-dose combination and should not be used for initial therapy in patients who require individualized dose titration of candesartan and hydrochlorothiazide.
  • Monitor serum potassium levels closely, especially at initiation and after dose changes, due to the opposing effects of candesartan (hyperkalemia risk) and hydrochlorothiazide (hypokalemia risk).
  • Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but potentially life-threatening side effect.
  • Educate patients about the importance of consistent daily dosing and not missing doses to maintain blood pressure control.
  • Caution patients about orthostatic hypotension, especially during initial therapy, dose increases, or when standing up quickly.
  • Hydrochlorothiazide can increase uric acid levels and may precipitate gout attacks in susceptible individuals.
  • This combination is particularly useful for patients whose blood pressure is not adequately controlled with either candesartan or hydrochlorothiazide alone.
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Alternative Therapies

  • Other Angiotensin II Receptor Blockers (ARBs) monotherapy (e.g., candesartan, valsartan)
  • Other Thiazide Diuretics monotherapy (e.g., hydrochlorothiazide, chlorthalidone)
  • ACE Inhibitors (e.g., lisinopril, enalapril)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Loop Diuretics (e.g., furosemide, torsemide) for patients with significant renal impairment or heart failure
  • Alpha-blockers (e.g., prazosin, doxazosin)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 happened.