Candesartan HCT 32-12.5mg Tablets

Manufacturer SOLCO HEALTHCARE 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
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters (FDA Pregnancy and Lactation Labeling Rule)
FDA Approved
Apr 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Candesartan 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 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.

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, so try to avoid taking it too close to bedtime to minimize sleep disturbances.

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're unsure about the best way to dispose of your medication, consult with your pharmacist or 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 your medication exactly as prescribed, usually once daily at the same time each day.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Limit your intake of sodium (salt) in your diet as directed by your doctor.
  • Maintain a healthy diet rich in fruits, vegetables, and whole grains.
  • Engage in regular physical activity as recommended by your doctor.
  • Limit alcohol consumption.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor, as this medication can affect potassium levels.
  • Stay well-hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 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 32 mg / 12.5 mg or 32 mg / 25 mg if needed. Max Candesartan 32 mg, Max HCT 25 mg.
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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 needed (CrCl >30 mL/min).
Moderate: No initial dose adjustment needed (CrCl >30 mL/min). Monitor renal function and electrolytes closely.
Severe: Contraindicated (CrCl <30 mL/min) due to hydrochlorothiazide ineffectiveness and potential for accumulation.
Dialysis: Not recommended. Candesartan is not dialyzable. Hydrochlorothiazide is dialyzable but combination is contraindicated in severe renal impairment.

Hepatic Impairment:

Mild: No initial dose adjustment needed for Candesartan. Use with caution for HCT.
Moderate: No initial dose adjustment needed for Candesartan. Use with caution for HCT, as minor fluid and electrolyte changes may precipitate hepatic coma.
Severe: Not studied for Candesartan. Contraindicated for HCT due to risk of hepatic coma.

Pharmacology

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Mechanism of Action

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 inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced sodium and water retention. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.
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Pharmacokinetics

Absorption:

Bioavailability: Candesartan: ~15% (from candesartan cilexetil prodrug); Hydrochlorothiazide: 50-80%
Tmax: Candesartan: 3-4 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Candesartan: No significant effect; Hydrochlorothiazide: Increases absorption slightly

Distribution:

Vd: Candesartan: 0.13 L/kg; Hydrochlorothiazide: 0.8 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: ~2.5-3.0 mL/min/kg
ExcretionRoute: Candesartan: Biliary (60%) and renal (33%); Hydrochlorothiazide: Renal
Unchanged: Candesartan: ~26% (renal); Hydrochlorothiazide: >95%
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Pharmacodynamics

OnsetOfAction: Candesartan: 2-4 hours; Hydrochlorothiazide: 2 hours
PeakEffect: Candesartan: 6-8 hours; Hydrochlorothiazide: 4-6 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Candesartan 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 Help Immediately

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 medical attention 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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or throwing up
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ A big weight gain
Signs of lupus, such as:
+ A rash on the cheeks or other body parts
+ Sunburn easy
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Eye problems, which can lead to lasting eyesight loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
+ Change in eyesight
+ Eye pain (usually occurs within hours to weeks of starting this medication)
Rarely, certain types of skin cancer have been reported in people taking hydrochlorothiazide. To minimize your risk:
+ Protect your skin from the sun
+ Have your skin checked as directed by your doctor
+ Contact your doctor immediately if you notice:
- A change in color or size of a mole
- Any new or changing skin lump or growth

Other Side Effects

Most people do not experience serious side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or any other side effects that bother you or do not go away, contact your doctor or seek medical attention:

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:

  • Signs of low blood pressure: severe dizziness, lightheadedness, fainting.
  • Signs of electrolyte imbalance: unusual tiredness, muscle weakness, muscle cramps, nausea, vomiting, confusion, irregular heartbeat.
  • Signs of kidney problems: swelling in your feet or ankles, unusual tiredness, dark urine, decreased urination.
  • Signs of allergic reaction or angioedema: swelling of your face, lips, tongue, or throat; difficulty breathing or swallowing.
  • Signs of high blood sugar: increased thirst, increased urination, dry mouth, fruity breath odor.
  • Signs of gout: sudden, severe joint pain, redness, swelling, warmth in a joint (often the big toe).
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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 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 be cautious when climbing stairs.

If you have diabetes (high blood sugar), this medication may occasionally increase your blood sugar levels. Consult your doctor about strategies to maintain control over your blood sugar. Monitor your blood pressure as directed, and undergo blood tests and other laboratory tests as scheduled by your doctor.

This medication may cause elevated cholesterol and triglyceride levels. Discuss this with your doctor. Additionally, it 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, and certain natural products or aids, consult your doctor.

Also, discuss with your doctor before consuming alcohol, marijuana or other cannabis products, or using prescription or OTC drugs that may slow your reactions.

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.

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
  • Dehydration
  • Electrolyte imbalances (e.g., hypokalemia, hyponatremia)
  • Nausea
  • Vomiting
  • Weakness

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, focusing on correcting hypotension and electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment [CrCl <60 mL/min])
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Major Interactions

  • Lithium (increased serum lithium levels and toxicity)
  • NSAIDs (including COX-2 inhibitors - reduced antihypertensive effect, increased risk of renal impairment, hyperkalemia)
  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • ACE inhibitors (increased risk of hyperkalemia, hypotension, renal impairment with dual RAS blockade)
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Moderate Interactions

  • Other antihypertensive agents (additive hypotensive effects)
  • Corticosteroids (increased risk of electrolyte disturbances, particularly hypokalemia)
  • Digoxin (HCT-induced hypokalemia may potentiate digoxin toxicity)
  • Antidiabetic agents (HCT may increase blood glucose levels, requiring adjustment of antidiabetic therapy)
  • Cholestyramine, colestipol (may reduce HCT absorption)
  • Muscle relaxants, non-depolarizing (enhanced effect due to HCT)
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Minor Interactions

  • Alcohol (additive hypotensive effect)
  • Barbiturates (additive hypotensive effect)
  • Opioids (additive hypotensive effect)

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 establish baseline and identify pre-existing imbalances, especially potassium due to HCT.

Timing: Prior to initiation

Renal Function (Serum Creatinine, BUN, eGFR)

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

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, especially with hepatic impairment.

Timing: Prior to initiation

Serum Uric Acid

Rationale: HCT can increase uric acid levels.

Timing: Prior to initiation

Blood Glucose

Rationale: HCT can affect glucose metabolism.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments (e.g., 1-2 weeks after initiation/adjustment), then monthly/quarterly.

Target: <130/80 mmHg (individualized per guidelines)

Action Threshold: Persistent elevation above target or symptomatic hypotension

Serum Electrolytes (Potassium, Sodium)

Frequency: 1-2 weeks after initiation/dose adjustment, 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 or >150 mEq/L, or symptomatic changes

Renal Function (Serum Creatinine, eGFR)

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

Target: Stable creatinine, eGFR >60 mL/min/1.73m²

Action Threshold: Increase in creatinine >30% from baseline or eGFR <30 mL/min/1.73m²

Serum Uric Acid

Frequency: Periodically, especially if patient has history of gout or symptoms.

Target: Not specified, monitor for trends

Action Threshold: Significant increase or onset of gout symptoms

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized per diabetes guidelines

Action Threshold: Significant increase or loss of glycemic control

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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, or decreased urination (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, redness)
  • Unusual bleeding or bruising (rare, due to HCT effects on platelets)

Special Patient Groups

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Pregnancy

Contraindicated in the 2nd and 3rd trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is generally discouraged due to potential risks.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for fetal harm cannot be excluded. HCT is Category B in 1st trimester, but ARB component is concerning.
Second Trimester: High risk of fetal injury (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death) due to Candesartan.
Third Trimester: High risk of fetal injury (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death) due to Candesartan.
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Lactation

Not recommended during breastfeeding. Both Candesartan and Hydrochlorothiazide are excreted in human milk. Hydrochlorothiazide can also suppress lactation.

Infant Risk: Moderate risk. Potential for adverse effects on the infant (e.g., hypotension, electrolyte imbalance, reduced milk supply).
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Pediatric Use

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

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the effects of Candesartan HCT, particularly hypotension and changes in renal function and electrolytes. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • This combination is typically used when monotherapy with either an ARB or a diuretic is insufficient to control blood pressure.
  • Take the medication at the same time each day, preferably in the morning, to maximize its blood pressure-lowering effect throughout the day and avoid nocturia from the diuretic.
  • Monitor for signs of orthostatic hypotension, especially when initiating therapy, increasing dose, or in patients who are volume-depleted.
  • Educate patients on the importance of regular blood pressure monitoring at home.
  • Advise patients to report any symptoms of angioedema (swelling of face, lips, tongue, throat) immediately, although rare with ARBs compared to ACEIs.
  • Caution patients about the risk of hyperkalemia when co-administered with potassium-sparing diuretics, potassium supplements, or other drugs that increase potassium (e.g., NSAIDs, trimethoprim).
  • Caution patients about the risk of hypokalemia with HCT, especially if not adequately balanced by Candesartan's potassium-sparing effect, or with concomitant use of corticosteroids or laxatives.
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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: $10 - $30 per 30 tablets (generic)
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 is 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 an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.