Chlorthalidone 50mg 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
Mar 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). It works by making your kidneys remove more salt and water from your blood, which then leaves your body through urine.
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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 this medication with food as directed. Be aware that it may increase your urine production, so try to avoid taking it close to bedtime to minimize sleep disturbances. Continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms. 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 the medication exactly as prescribed, usually once daily in the morning to avoid nighttime urination.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • Maintain a balanced diet, potentially including potassium-rich foods if advised by your doctor, but avoid excessive salt intake.
  • Stay hydrated, but avoid excessive fluid intake unless advised by your doctor.
  • Limit alcohol consumption, as it can increase the risk of dizziness and low blood pressure.
  • Regularly monitor your blood pressure at home if advised by your doctor.
  • Be aware of symptoms of dehydration or electrolyte imbalance, especially during hot weather or illness (e.g., vomiting, diarrhea).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 25 mg orally once daily; Edema: 50-100 mg orally once daily or 100 mg orally every other day
Dose Range: 12.5 - 100 mg

Condition-Specific Dosing:

Hypertension: Initial: 12.5-25 mg orally once daily; Max: 50 mg orally once daily (doses >25 mg rarely provide additional benefit and increase risk of adverse effects)
Edema: Initial: 50-100 mg orally once daily or 100 mg orally every other day; Max: 200 mg orally once daily (rarely used)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Edema: 0.2 mg/kg/dose orally once daily or 0.4 mg/kg/dose orally every other day; Max: 10 mg/kg/dose or 50 mg/day, whichever is less. Hypertension: 0.2 mg/kg/dose orally once daily; Max: 50 mg/day.
Adolescent: Hypertension: 12.5-25 mg orally once daily; Max: 50 mg orally once daily. Edema: 50-100 mg orally once daily or 100 mg orally every other day.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >50 mL/min)
Moderate: Use with caution; may be less effective (CrCl 10-50 mL/min). Consider lower doses.
Severe: Generally not recommended or ineffective (CrCl <10 mL/min). Loop diuretics are preferred.
Dialysis: Not removed by dialysis. Avoid use in anuric patients.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution due to risk of hepatic coma in severe impairment.
Moderate: Use with caution; monitor for electrolyte imbalances and signs of hepatic encephalopathy.
Severe: Contraindicated in hepatic coma or precoma.

Pharmacology

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Mechanism of Action

Chlorthalidone is a phthalimidine derivative, a long-acting sulfonamide diuretic, chemically related to thiazide diuretics. It acts primarily in the cortical diluting segment of the distal convoluted tubule, where it inhibits the reabsorption of sodium and chloride ions by blocking the Na+/Cl- cotransporter (NCC). This leads to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. It also decreases calcium excretion. The antihypertensive effect is initially due to a reduction in plasma volume and cardiac output, followed by a decrease in peripheral vascular resistance with chronic use.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 65%
Tmax: 2-6 hours
FoodEffect: Food may slightly increase absorption and reduce gastrointestinal upset.

Distribution:

Vd: Approximately 4-13 L/kg
ProteinBinding: Approximately 75% (primarily to carbonic anhydrase in red blood cells)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 40-60 hours (highly variable, can range from 35-100 hours)
Clearance: Renal clearance is approximately 2.5 mL/min/kg
ExcretionRoute: Renal (primarily unchanged drug)
Unchanged: Approximately 50-70% of absorbed dose
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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 Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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 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 vomiting
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Erectile dysfunction
Restlessness
Yellowing of the skin or eyes
Changes in vision
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak

Other Possible Side Effects

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

Dizziness
Fatigue
Weakness
Headache
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Stomach cramps

Reporting Side Effects

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
  • Nausea or vomiting
  • Excessive thirst or dry mouth
  • Decreased urination
  • Swelling in hands or feet (paradoxical, if due to worsening heart failure or kidney issues)
  • Sudden, severe joint pain (especially in the big toe, indicating 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. Be sure to describe the allergic reaction and its symptoms.
A known sulfa allergy.
If you have difficulty urinating.
If you are breastfeeding. Note that you should not breastfeed while taking this medication.

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

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

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 tests, as this medication may impact certain lab results. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test interpretations.

Before consuming alcohol, marijuana, or other substances that may impair your actions, consult with your doctor. If you have diabetes, closely monitor your blood sugar levels, as this medication can affect them. Be aware of signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them to your doctor.

If you have high blood pressure, consult with your doctor before taking over-the-counter (OTC) products that may increase blood pressure, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

This medication is a potent diuretic, which can lead to excessive loss of water and electrolytes (such as potassium) in the blood. Your doctor will closely monitor you to adjust the dosage according to your body's needs. Be aware of the risk of gout attacks and discuss any concerns with your doctor.

If you are on a low-sodium or sodium-free diet, inform your doctor, as this may affect your treatment plan. This medication can increase your sensitivity to the sun, making you more prone to sunburn. Take precautions when exposed to sunlight, and report any unusual sunburn or sensitivity to your doctor.

If you are pregnant or planning to become pregnant, discuss the benefits and risks of taking this medication with your doctor to ensure your safety and the well-being of your unborn child.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis (excessive urination)
  • Severe dehydration
  • Electrolyte depletion (especially hypokalemia, hyponatremia)
  • Hypotension (low blood pressure)
  • Dizziness, weakness, confusion
  • Cardiac arrhythmias (due to electrolyte imbalance)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, focusing on fluid and electrolyte replacement.

Drug Interactions

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Contraindicated Interactions

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

  • Lithium (increased lithium toxicity due to decreased renal clearance)
  • Dofetilide (increased risk of QT prolongation and torsades de pointes)
  • Cisapride (increased risk of QT prolongation)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (may reduce diuretic, natriuretic, and antihypertensive effects of chlorthalidone; increased risk of renal impairment)
  • Corticosteroids (increased risk of hypokalemia)
  • Digoxin (increased risk of digoxin toxicity due to hypokalemia)
  • Other antihypertensives (additive hypotensive effects)
  • Neuromuscular blocking agents (prolonged neuromuscular blockade due to hypokalemia)
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Moderate Interactions

  • Antidiabetic agents (may decrease glucose tolerance, requiring adjustment of antidiabetic therapy)
  • Cholestyramine/Colestipol (may reduce absorption of chlorthalidone; administer chlorthalidone 1 hour before or 4 hours after)
  • Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
  • Pressor amines (e.g., norepinephrine) (decreased arterial responsiveness)
  • Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
  • Amantadine (increased risk of amantadine toxicity)
  • Cyclosporine (increased risk of hyperuricemia and gout)
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Minor Interactions

  • Calcium salts (increased risk of hypercalcemia)
  • Vitamin D (increased risk of hypercalcemia)

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 efficacy is reduced in severe renal impairment and it can worsen renal function in some patients.

Timing: Prior to initiation of therapy

Blood Pressure

Rationale: To establish baseline and guide therapy for hypertension.

Timing: Prior to initiation of therapy

Uric Acid

Rationale: Chlorthalidone can increase serum uric acid levels, potentially precipitating gout.

Timing: Prior to initiation of therapy

Blood Glucose

Rationale: Chlorthalidone can cause hyperglycemia, especially in patients with diabetes or pre-diabetes.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Frequency: Weekly for the first few weeks, 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 (consider dose reduction or discontinuation); Significant deviations from normal range.

Renal Function (BUN, Serum Creatinine)

Frequency: Every 3-6 months or as clinically indicated, especially in elderly or those with pre-existing renal impairment.

Target: Within normal limits for age/sex

Action Threshold: Significant increase in BUN/creatinine (e.g., >20-30% above baseline or worsening renal function)

Blood Pressure

Frequency: Regularly, as per hypertension guidelines (e.g., monthly until controlled, then every 3-6 months).

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

Action Threshold: Failure to achieve target blood pressure or symptomatic hypotension.

Uric Acid

Frequency: Every 6-12 months or if symptoms of gout develop.

Target: Within normal limits (e.g., <7 mg/dL for men, <6 mg/dL for women)

Action Threshold: Symptomatic hyperuricemia or significant elevation.

Blood Glucose

Frequency: Every 6-12 months, more frequently in diabetic patients.

Target: Fasting glucose <100 mg/dL; HbA1c <5.7% (for non-diabetics)

Action Threshold: Significant increase in blood glucose or new onset hyperglycemia.

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Symptom Monitoring

  • Signs of electrolyte imbalance (e.g., muscle weakness, cramps, fatigue, irregular heart beat, confusion, nausea, vomiting, excessive thirst)
  • Signs of dehydration (e.g., dry mouth, decreased urination, dizziness, lightheadedness)
  • Symptoms of gout (e.g., acute joint pain, swelling, redness)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue)
  • Orthostatic hypotension (dizziness upon standing)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless essential. Potential for fetal harm not ruled out.
Second Trimester: May be used if clearly indicated for conditions like gestational hypertension, but close monitoring is required. Risk of decreased placental perfusion.
Third Trimester: Risk of neonatal jaundice, thrombocytopenia, and other adverse reactions that have occurred in adults. May decrease plasma volume and placental perfusion.
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Lactation

Chlorthalidone is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant (e.g., electrolyte disturbances, suppression of lactation), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately safe). Potential for electrolyte disturbances, dehydration, and suppression of lactation. Monitor infant for signs of dehydration or electrolyte imbalance.
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Pediatric Use

Use with caution. Dosing is weight-based. Safety and efficacy in infants and very young children are not well-established. Electrolyte imbalances are a significant concern.

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Geriatric Use

Elderly patients may be more sensitive to the effects of chlorthalidone, particularly regarding electrolyte imbalances (e.g., hypokalemia, hyponatremia) and orthostatic hypotension. Lower starting doses and careful monitoring are recommended.

Clinical Information

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Clinical Pearls

  • Chlorthalidone has a significantly longer half-life (40-60 hours) compared to hydrochlorothiazide (6-15 hours), allowing for sustained blood pressure control with once-daily dosing.
  • Current hypertension guidelines (e.g., JNC 8, ACC/AHA) often recommend chlorthalidone as a preferred thiazide-type diuretic due to its superior efficacy in reducing cardiovascular events compared to hydrochlorothiazide in some studies.
  • Administer in the morning to prevent nocturia (nighttime urination).
  • Monitor for electrolyte imbalances (especially potassium, sodium, magnesium) and uric acid levels, particularly during initiation of therapy and dose adjustments.
  • May cause photosensitivity; advise patients to use sunscreen and protective clothing.
  • Less effective in patients with severe renal impairment (CrCl <30 mL/min); loop diuretics are generally preferred in these cases.
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Alternative Therapies

  • ACE inhibitors (e.g., lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine)
  • Beta-blockers (e.g., metoprolol)
  • Loop Diuretics (e.g., furosemide, torsemide - for more potent diuresis, especially in renal impairment or heart failure)
  • Potassium-sparing Diuretics (e.g., spironolactone, amiloride - often used in combination to counteract potassium loss)
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Cost & Coverage

Average Cost: Varies, typically low cost per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (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 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.