Chlorthalidone 25mg Tablets

Manufacturer SUN PHARMACEUTICALS Active Ingredient Chlorthalidone(klor THAL i done) Pronunciation klor THAL i done
It is used to treat high blood pressure.It is used to get rid of extra fluid.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Diuretic
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Pharmacologic Class
Thiazide-like Diuretic
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Pregnancy Category
C
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FDA Approved
Jan 1960
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Chlorthalidone is a 'water pill' (diuretic) that helps your body get rid of extra salt and water. This helps to lower your blood pressure and reduce swelling (edema) in your body.
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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. Take your medication with food to help your body absorb it properly.

It's common for this medication to increase urine production, so try to take it earlier in the day to avoid disrupting your sleep. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, away from the bathroom. Store all medications in a safe location, out of reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist for guidance. 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once a day in the morning to avoid nighttime urination.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Follow a low-sodium (low-salt) diet as advised by your doctor or dietitian.
  • Maintain regular physical activity and a healthy weight.
  • Limit alcohol intake as it can also lower blood pressure and increase dizziness.
  • Report any signs of electrolyte imbalance (e.g., muscle cramps, weakness, unusual tiredness, irregular heartbeat, excessive thirst) to your doctor immediately.
  • Stand up slowly from a sitting or lying position to prevent dizziness.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 25 mg orally once daily. Edema: 25-100 mg orally once daily or every other day.
Dose Range: 12.5 - 100 mg

Condition-Specific Dosing:

Hypertension: Initial: 25 mg once daily; may increase to 50 mg once daily if needed. Doses above 25 mg generally do not provide additional blood pressure reduction but increase adverse effects.
Edema: Initial: 50-100 mg once daily or 100 mg every other day. Maintenance: 25-50 mg once daily or every other day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (off-label): 0.3 mg/kg/day orally once daily (max 50 mg/day). Edema (off-label): 0.5-2 mg/kg/day orally once daily or every other day.
Adolescent: Hypertension (off-label): 0.3 mg/kg/day orally once daily (max 50 mg/day). Edema (off-label): 0.5-2 mg/kg/day orally once daily or every other day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically needed (CrCl > 50 mL/min).
Moderate: Use with caution (CrCl 30-50 mL/min). May be less effective. Consider lower doses.
Severe: Contraindicated or generally not recommended (CrCl < 30 mL/min) due to lack of efficacy and increased risk of adverse effects.
Dialysis: Not effective in anuric patients. Not significantly removed by dialysis.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; may precipitate hepatic coma in susceptible patients.
Severe: Use with extreme caution; contraindicated in severe hepatic impairment or hepatic coma.

Pharmacology

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Mechanism of Action

Chlorthalidone is a phthalimidine derivative, a long-acting sulfonamide diuretic. It acts primarily in the cortical diluting segment of the ascending limb of the loop of Henle and the early distal convoluted tubule, where it inhibits the reabsorption of sodium and chloride ions. This increases the excretion of sodium, chloride, and water, leading to diuresis. It also increases the excretion of potassium and magnesium and decreases the excretion of calcium and uric acid. Its antihypertensive effect is thought to be due to a reduction in plasma volume and extracellular fluid, and possibly a direct vasodilatory effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 65%
Tmax: 2-6 hours
FoodEffect: Food may slightly increase the rate and extent of absorption, but it is not clinically significant.

Distribution:

Vd: Approximately 4-6 L/kg
ProteinBinding: Approximately 75% (primarily to carbonic anhydrase in red blood cells)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 40-60 hours (highly variable, can be up to 100 hours)
Clearance: Not readily available, primarily renal clearance.
ExcretionRoute: Renal (urine) and biliary (feces)
Unchanged: Approximately 50-70% renally excreted unchanged.
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Pharmacodynamics

OnsetOfAction: 2-3 hours
PeakEffect: 2-6 hours
DurationOfAction: 24-72 hours

Safety & Warnings

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Side Effects

Serious 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
+ 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 fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of kidney problems, such as:
+ Unable to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problems), including:
+ Severe stomach pain
+ Severe back pain
+ Severe stomach upset or vomiting
Abnormal sensations, such as burning, numbness, or tingling
Erectile dysfunction
Restlessness
Yellowing of the skin or eyes
Changes in vision
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dizziness
Fatigue
Weakness
Headache
Constipation
Diarrhea
Stomach upset
Vomiting
Decreased appetite
Stomach cramps

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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
  • Unusual muscle weakness or cramps
  • Irregular or fast heartbeat
  • Extreme thirst or dry mouth
  • Nausea or vomiting that doesn't go away
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Sudden joint pain or swelling (signs of gout)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A known sulfa allergy, as this may affect your ability to take this medication safely.
Any difficulties with urination, as this medication may not be suitable for individuals with certain urinary problems.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have or have had in the past

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. This will help prevent any potential interactions or adverse effects.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure they are aware of any potential interactions or effects.

To minimize the risk of accidents, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying position, rise slowly to reduce the likelihood of dizziness or fainting. Be cautious when climbing stairs.

Regularly check your blood pressure as instructed by your healthcare provider. This medication may cause elevated cholesterol and triglyceride levels, so it is crucial to discuss this with your doctor.

Follow your doctor's instructions for blood work and laboratory tests, as this medication may affect certain test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Before consuming alcohol, marijuana, or other cannabis products, or using prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. If you have diabetes, closely monitor your blood sugar levels, as this medication can cause symptoms such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Report any of these symptoms to your doctor.

If you have high blood pressure, consult with your doctor before taking 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.

This medication is a potent diuretic, which can lead to excessive loss of water and electrolytes (like potassium) in the blood. Your doctor will closely monitor you and adjust the dosage as needed to prevent severe health complications.

Be aware of the potential for gout attacks, and if you are on a low-sodium or sodium-free diet, discuss this with your doctor. This medication may increase your sensitivity to the sun, so take precautions when exposed to sunlight and report any unusual sunburn to your doctor.

If you are pregnant or plan to become pregnant, consult with your doctor to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Weakness
  • Dizziness
  • Dry mouth
  • Thirst
  • Vomiting
  • Lethargy
  • Confusion
  • Hypotension (low blood pressure)
  • Electrolyte disturbances (e.g., severe hypokalemia, hyponatremia)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is supportive and symptomatic, focusing on correcting fluid and electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Anuria
  • Hypersensitivity to chlorthalidone or other sulfonamide-derived drugs
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Major Interactions

  • Lithium (increased lithium toxicity due to decreased renal clearance)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (reduced diuretic and antihypertensive effects)
  • Digoxin (increased risk of digoxin toxicity due to hypokalemia)
  • Corticosteroids (increased risk of hypokalemia)
  • Other Antihypertensives (additive hypotensive effects)
  • Amphotericin B (increased risk of hypokalemia)
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Moderate Interactions

  • Antidiabetic agents (may decrease glucose tolerance, requiring adjustment of antidiabetic dose)
  • Cholestyramine, Colestipol (may reduce absorption of chlorthalidone; administer chlorthalidone 1 hour before or 4 hours after these agents)
  • Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
  • Neuromuscular blocking agents (enhanced effect due to hypokalemia)
  • Pressor amines (e.g., norepinephrine) (decreased arterial responsiveness)
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Minor Interactions

  • Not typically categorized as minor for drug-drug interactions, but general caution with other medications that affect electrolytes.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To establish baseline levels and identify pre-existing imbalances, as chlorthalidone can cause hypokalemia, hyponatremia, hypomagnesemia, and hypercalcemia.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine)

Rationale: To assess baseline kidney function, as chlorthalidone is renally eliminated and less effective in severe renal impairment.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline blood pressure and guide initial dosing.

Timing: Prior to initiation of therapy.

Blood Glucose

Rationale: To establish baseline, as chlorthalidone can cause hyperglycemia.

Timing: Prior to initiation of therapy.

Serum Uric Acid

Rationale: To establish baseline, as chlorthalidone can cause hyperuricemia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

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

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L; Magnesium: 1.7-2.2 mg/dL; Calcium: 8.5-10.2 mg/dL

Action Threshold: Potassium < 3.0 mEq/L (consider supplementation or dose reduction); Sodium < 130 mEq/L (investigate cause, consider dose reduction); Significant deviations from normal ranges.

Renal Function (BUN, Serum Creatinine)

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

Target: Within normal limits for age and sex.

Action Threshold: Significant increase in BUN/Creatinine (e.g., >20-30% from baseline) or CrCl < 30 mL/min (consider dose reduction or discontinuation).

Blood Pressure

Frequency: Regularly, at each clinic visit or as directed by healthcare provider.

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

Action Threshold: Failure to achieve target BP, or symptomatic hypotension.

Blood Glucose

Frequency: Periodically, especially in patients with diabetes or risk factors for diabetes.

Target: Fasting: <100 mg/dL; HbA1c: <7% for most diabetics.

Action Threshold: Persistent hyperglycemia or worsening glycemic control.

Serum Uric Acid

Frequency: Periodically, especially in patients with a history of gout or hyperuricemia.

Target: Within normal limits (e.g., 3.5-7.2 mg/dL).

Action Threshold: Symptomatic gout or persistent significant hyperuricemia.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Muscle cramps or weakness
  • Excessive thirst or dry mouth
  • Nausea or vomiting
  • Fatigue or lethargy
  • Irregular heartbeat
  • Swelling in ankles or feet (if edema is worsening)
  • Signs of gout (joint pain, swelling, redness)

Special Patient Groups

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Pregnancy

Category C. Chlorthalidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Routine use in otherwise healthy pregnant women with mild edema is not recommended as it may lead to reduced placental perfusion.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly indicated.
Second Trimester: May be used if essential for managing severe hypertension, but close monitoring for fetal growth restriction and electrolyte imbalances is crucial.
Third Trimester: Avoided near term due to potential for neonatal jaundice, thrombocytopenia, and other adverse effects.
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Lactation

Excreted in breast milk. Use with caution. May suppress lactation. The American Academy of Pediatrics considers it compatible with breastfeeding, but monitor infant for potential adverse effects (e.g., dehydration, electrolyte imbalance).

Infant Risk: Low to Moderate. Potential for dehydration, electrolyte imbalance, and suppression of lactation. Observe infant for signs of fluid/electrolyte disturbance.
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Pediatric Use

Safety and efficacy not fully established in pediatric patients. Use is generally off-label and with caution, typically for hypertension or edema when other agents are not suitable. Dosing is weight-based and requires careful monitoring of fluid and electrolytes.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive and electrolyte-disturbing effects (e.g., hypokalemia, hyponatremia) of chlorthalidone. Lower initial doses and careful monitoring are recommended. Renal function should be assessed before and during therapy.

Clinical Information

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Clinical Pearls

  • Chlorthalidone has a very long half-life (40-60 hours), allowing for once-daily dosing and providing sustained blood pressure control.
  • It is often preferred over hydrochlorothiazide in hypertension guidelines (e.g., JNC 8, ACC/AHA) due to evidence of superior cardiovascular outcome benefits, possibly related to its longer duration of action and higher potency.
  • Despite its long half-life, it is typically dosed in the morning to prevent nocturia.
  • Hypokalemia is a common side effect; potassium supplementation or co-administration with potassium-sparing diuretics may be necessary, especially in patients at high risk (e.g., on digoxin, with arrhythmias).
  • Can cause hyperuricemia and may precipitate gout attacks in susceptible individuals.
  • Less effective in patients with severe renal impairment (CrCl < 30 mL/min).
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Alternative Therapies

  • Other Thiazide Diuretics (e.g., Hydrochlorothiazide, Indapamide)
  • Loop Diuretics (e.g., Furosemide, Torsemide, Bumetanide) - for more potent diuresis, especially in renal impairment
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Potassium-sparing Diuretics (e.g., Spironolactone, Amiloride, Triamterene)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Preferred Generic)
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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 this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.