Atacand HCT 32-12.5mg Tablets

Manufacturer ANI PHARMACEUTICALS 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) / Thiazide Diuretic Combination
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Pregnancy Category
Not applicable (FDA has moved away from letter categories, but historically D/X for ARBs in 2nd/3rd trimester, and HCTZ is D in 2nd/3rd trimester. Current labeling states 'Do not use in pregnancy.')
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FDA Approved
Jan 2000
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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, a 'water pill' that 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

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. Continue taking it as prescribed by your doctor or healthcare provider, even if you're feeling well.

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 your urine production. To minimize sleep disturbances, try to avoid taking it too close to bedtime.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missing 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 consistently, 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.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Stay hydrated, but avoid excessive fluid intake unless advised by your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet (Candesartan 32 mg / Hydrochlorothiazide 12.5 mg) orally once daily.
Dose Range: 16 - 32 mg

Condition-Specific Dosing:

Hypertension: Initial dose typically Candesartan 16 mg / Hydrochlorothiazide 12.5 mg once daily. May be titrated up to Candesartan 32 mg / Hydrochlorothiazide 25 mg once daily based on blood pressure response. The 32-12.5mg strength is for patients whose blood pressure is not adequately controlled on Candesartan monotherapy or lower doses of the 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 dosage adjustment required (CrCl > 30 mL/min).
Moderate: Use with caution. Not recommended for patients with severe renal impairment (CrCl < 30 mL/min) due to the hydrochlorothiazide component.
Severe: Contraindicated (CrCl < 30 mL/min) due to the hydrochlorothiazide component.
Dialysis: Not recommended for use in patients on dialysis.

Hepatic Impairment:

Mild: No dosage adjustment required.
Moderate: Use with caution. Candesartan exposure may be increased. Hydrochlorothiazide should be used with caution in patients with impaired hepatic function or progressive liver disease, as minor alterations of fluid and electrolyte balance 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 and reduced sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic. It inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule of the nephron, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This results in reduced plasma volume and peripheral vascular resistance.
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Pharmacokinetics

Absorption:

Bioavailability: Candesartan: ~15% (as candesartan cilexetil is a prodrug); Hydrochlorothiazide: 65-75%
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: Limited

Elimination:

HalfLife: Candesartan: ~9 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Candesartan: ~0.37 mL/min/kg; Hydrochlorothiazide: Renal clearance is ~2.5 mL/min/kg
ExcretionRoute: Candesartan: Urine (26%) and bile (74%); Hydrochlorothiazide: Primarily renal (unchanged)
Unchanged: Candesartan: ~26% (renal); Hydrochlorothiazide: >95% (renal)
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Pharmacodynamics

OnsetOfAction: Candesartan: Within 2 hours; Hydrochlorothiazide: Within 2 hours
PeakEffect: Candesartan: 4-8 weeks for full BP effect; Hydrochlorothiazide: 4 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

Serious 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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or fruity-smelling breath.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling very tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of lupus: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.

Eye Problems

This medication can cause certain eye problems, which can lead to permanent vision loss if left untreated. If you experience any eye problems, symptoms such as changes in vision or eye pain usually occur within hours to weeks of starting this medication. Contact your doctor immediately if you experience these symptoms.

Skin Cancer Risk

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize this risk, protect your skin from the sun and 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 Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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
  • Signs of electrolyte imbalance: unusual weakness, muscle cramps, confusion, irregular heartbeats
  • Signs of kidney problems: little or no urination, swelling in your feet or ankles, feeling tired or short of breath
  • Signs of allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat (angioedema)
  • Unusual bruising or bleeding
  • Yellowing of skin or eyes (jaundice)
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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. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Difficulty urinating.
Kidney disease or kidney problems.
High calcium levels in your blood.
* Use of a medication containing aliskiren, especially if you have diabetes or kidney problems.

Additionally, if you are breast-feeding or plan to breast-feed, you should discuss this with your doctor.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.

Managing Diabetes and Blood Pressure
If you have diabetes, this medication may increase your blood sugar levels. Consult your doctor about maintaining control over your blood sugar. Monitor your blood pressure as directed by your doctor. Additionally, have your blood work and other laboratory tests checked as recommended by your doctor.

Potential Effects on Cholesterol and Triglyceride Levels
This medication may cause elevated cholesterol and triglyceride levels. Discuss this with your doctor.

Impact on Laboratory Tests
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Interactions with Other Medications and Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. 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, consult your doctor. Also, discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or OTC medications that may slow your reactions, with your doctor.

Precautions in Hot Weather and with Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Lupus Considerations
If you have lupus, this medication may activate or worsen the condition. Inform your doctor immediately if you experience any new or worsening symptoms.

Timing of Full Effect
It may take approximately one month to experience the full effects of this medication.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Dizziness
  • Fainting
  • Tachycardia (fast heart rate)
  • Bradycardia (slow heart rate)
  • Electrolyte disturbances (e.g., hypokalemia, hyponatremia)
  • Dehydration

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including intravenous fluids for hypotension and correction of electrolyte imbalances.

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 risk of hyperkalemia
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Major Interactions

  • Lithium (increased lithium levels and toxicity)
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib) - reduced antihypertensive effect, increased risk of renal impairment
  • Other antihypertensives (additive hypotensive effects)
  • Digoxin (thiazides may increase digoxin toxicity due to hypokalemia)
  • Corticosteroids (enhanced electrolyte depletion, particularly hypokalemia)
  • Cholestyramine and colestipol resins (reduced absorption of hydrochlorothiazide)
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Moderate Interactions

  • Alcohol, barbiturates, or narcotics (potentiation of orthostatic hypotension)
  • Antidiabetic drugs (oral agents and insulin) - thiazides may decrease glucose tolerance, requiring dosage adjustment
  • Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines
  • Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide therapy.

Timing: Prior to initiation

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To assess baseline electrolyte status, as both components can affect levels (Candesartan: hyperkalemia risk; HCTZ: hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia).

Timing: Prior to initiation

Renal Function (Serum Creatinine, BUN, eGFR)

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

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially given caution in hepatic impairment.

Timing: Prior to initiation

Uric Acid

Rationale: Hydrochlorothiazide can increase uric acid levels.

Timing: Prior to initiation

Blood Glucose

Rationale: Hydrochlorothiazide can affect glucose tolerance.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly initially, then monthly or as clinically indicated

Target: <130/80 mmHg or individualized target

Action Threshold: Persistent BP above target, or symptomatic hypotension

Serum Electrolytes (Potassium, Sodium)

Frequency: Within 1-2 weeks of 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 <3.0 or >5.5 mEq/L; Sodium <130 mEq/L or symptomatic hyponatremia

Renal Function (Serum Creatinine, BUN)

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

Target: Stable within patient's baseline range

Action Threshold: Increase in creatinine >30% from baseline, or significant decrease in eGFR

Uric Acid

Frequency: Periodically, especially if history of gout

Target: Within normal limits

Action Threshold: Elevated levels, especially if symptomatic gout

Blood Glucose

Frequency: Periodically, especially in diabetic patients

Target: Individualized glycemic targets

Action Threshold: Significant hyperglycemia

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Excessive thirst or dry mouth (signs of dehydration)
  • Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
  • Persistent cough (less common with ARBs than ACEIs, but possible)
  • Signs of gout (joint pain, swelling)

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy, especially during the second and third trimesters. Discontinue as soon as pregnancy is detected.

Trimester-Specific Risks:

First Trimester: Limited data, but ARBs are generally considered to pose a theoretical risk of teratogenicity. HCTZ is generally considered low risk in the first trimester.
Second Trimester: High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death) due to ARB component.
Third Trimester: High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death) due to ARB component.
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Lactation

Not recommended. Both candesartan and hydrochlorothiazide are excreted in breast milk. Potential for serious adverse effects in the nursing infant.

Infant Risk: Moderate risk (L3). Potential for hypotension, hyperkalemia (candesartan), and electrolyte disturbances, dehydration, and reduced milk supply (hydrochlorothiazide).
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Not recommended for use.

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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 monitor renal function and electrolytes closely due to increased likelihood of impaired renal function and polypharmacy.

Clinical Information

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Clinical Pearls

  • This combination is typically used when monotherapy with either an ARB or a thiazide diuretic is insufficient to control blood pressure.
  • Take consistently at the same time each day, with or without food.
  • Monitor for signs of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat), especially potassium levels.
  • Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically advised by a physician.
  • Patients with a history of gout may experience exacerbations due to the hydrochlorothiazide component.
  • Inform patients about the black box warning regarding pregnancy and the need to discontinue immediately if pregnancy is detected.
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Alternative Therapies

  • Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, other diuretics)
  • Monotherapy with Candesartan or Hydrochlorothiazide if blood pressure is adequately controlled.
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so be sure to check with your pharmacist for more details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.