Hygroton 50mg Tablets

Manufacturer RHONE 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 sodium and water from your blood.
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How to Use This Medicine

Taking Your Medication

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 feeling better.

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 and secure location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.

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 a missed one.
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Lifestyle & Tips

  • Take chlorthalidone exactly as prescribed, usually once daily in the morning to avoid nighttime urination.
  • Do not stop taking this medication without consulting your doctor, even if you feel well.
  • Follow a low-sodium diet as recommended by your doctor or dietitian.
  • Maintain adequate fluid intake unless otherwise advised by your doctor.
  • If you experience dizziness or lightheadedness, especially when standing up, rise slowly from a sitting or lying position.
  • Limit alcohol intake, as it can increase the risk of dizziness.
  • Discuss potassium-rich foods or potassium supplements with your doctor, as this medication can lower potassium levels.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 25 mg once daily; Edema: 50-100 mg 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 50 mg generally do not provide additional benefit and increase adverse effects.
edema: Initial 50-100 mg once daily or every other day. Some patients may require 150-200 mg daily initially, then reduced for maintenance.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; limited data for hypertension (0.5-2 mg/kg/day divided, max 50 mg/day)
Adolescent: Not established for routine use; limited data for hypertension (0.5-2 mg/kg/day divided, max 50 mg/day)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed (CrCl > 50 mL/min)
Moderate: Use with caution (CrCl 30-50 mL/min); reduced efficacy, increased risk of adverse effects.
Severe: Generally ineffective and not recommended (CrCl < 30 mL/min). Loop diuretics are preferred.
Dialysis: Not removed by dialysis; generally not used in anuric patients.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: Use with caution; increased risk of hepatic coma in predisposed patients.
Severe: Use with caution; increased risk of hepatic coma in predisposed patients.

Pharmacology

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Mechanism of Action

Chlorthalidone is a thiazide-like diuretic that acts primarily in the cortical diluting segment of the distal convoluted tubule. It inhibits the reabsorption of sodium and chloride ions by blocking the Na+/Cl- cotransporter (NCC), leading to increased excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion. Its antihypertensive effect is thought to be due to a reduction in plasma volume and peripheral vascular resistance.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 64%
Tmax: 2-6 hours
FoodEffect: Food may slightly increase absorption but 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: 40-60 hours (highly variable, can be up to 100 hours in some individuals)
Clearance: Not readily available, but primarily renal.
ExcretionRoute: Renal (primarily unchanged)
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 notice 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, including:
+ 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), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach 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 very 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 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 list is not exhaustive, and you may experience other 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
  • Muscle cramps, weakness, or spasms
  • Unusual tiredness or fatigue
  • Irregular or fast heartbeat
  • Excessive thirst or dry mouth
  • Nausea or vomiting
  • Confusion or mood changes
  • Sudden, severe joint pain (especially in the big toe, indicating gout)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 symptoms you experienced.
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 any potential interactions with other treatments.

To minimize the risk of accidents, avoid driving and engaging in activities that require your full attention until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to reduce the likelihood of feeling dizzy or lightheaded. Be cautious when climbing stairs to avoid falls.

Regularly monitor your blood pressure as directed by your healthcare provider. This medication may cause an increase in cholesterol and triglyceride levels, so it is crucial to discuss this with your doctor.

Follow your doctor's instructions for getting blood work done, as this medication may impact certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test results.

Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you have diabetes, closely monitor your blood sugar levels, as this medication may affect them. Be aware of the 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, talk to your doctor before taking any over-the-counter 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 means it can cause your body to lose excess water and electrolytes, such as potassium. This can lead to severe health problems if not properly managed. Your doctor will closely monitor you and adjust the dosage as needed to ensure your body's needs are met.

Be aware of the potential for gout attacks while taking this medication. If you are on a low-sodium or sodium-free diet, discuss this with your doctor to ensure safe treatment.

This medication may increase your risk of sunburn, so take precautions when spending time outdoors. If you experience easy sunburning while taking this medication, inform your doctor.

If you are pregnant or planning to become pregnant, discuss the benefits and risks of taking this medication with your doctor to make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Severe dehydration
  • Electrolyte imbalance (e.g., severe hypokalemia, hyponatremia)
  • Hypotension (low blood pressure)
  • Dizziness, weakness, confusion
  • Nausea, vomiting
  • Cardiac arrhythmias

What to Do:

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

Drug Interactions

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Major Interactions

  • Lithium (increased lithium toxicity)
  • Dofetilide (increased dofetilide levels, risk of arrhythmias)
  • Corticosteroids (increased risk of hypokalemia)
  • Digoxin (increased risk of digoxin toxicity with hypokalemia)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (reduced diuretic/antihypertensive effect, increased risk of renal impairment)
  • Antidiabetic agents (may decrease hypoglycemic effect)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effect)
  • Muscle relaxants, non-depolarizing (potentiated effect)
  • Cholestyramine/Colestipol (reduced chlorthalidone absorption)
  • Alcohol, barbiturates, narcotics (additive orthostatic hypotension)
  • Pressor amines (e.g., norepinephrine) (decreased arterial responsiveness)

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, eGFR)

Rationale: To assess 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: Within 1-2 weeks of initiation or dose change, 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, eGFR)

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

Target: Normal ranges for age and sex.

Action Threshold: Significant increase in BUN/Creatinine or decrease in eGFR (e.g., >20-30% from baseline).

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 BP, or symptomatic hypotension.

Uric Acid

Frequency: Periodically, especially if patient develops symptoms of gout.

Target: Normal ranges.

Action Threshold: Symptomatic hyperuricemia or significant elevation.

Blood Glucose

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

Target: Fasting glucose <100 mg/dL (non-diabetic); individualized for diabetic patients.

Action Threshold: Significant hyperglycemia.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Chlorthalidone is generally not recommended for routine use in healthy pregnant women with mild edema or hypertension, as it may reduce placental perfusion and is associated with potential fetal/neonatal adverse effects (e.g., jaundice, thrombocytopenia, electrolyte disturbances). Use only if clearly needed and the benefit outweighs the potential risk.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential for fetal effects.
Second Trimester: Potential for reduced placental perfusion and fetal growth restriction.
Third Trimester: Increased risk of neonatal jaundice, thrombocytopenia, and electrolyte disturbances (e.g., hypokalemia, hyponatremia).
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Lactation

Chlorthalidone is excreted in breast milk. While the amount is generally small, it can potentially decrease milk supply due to its diuretic effect. Use with caution; monitor the infant for signs of dehydration or electrolyte imbalance. Consider alternative antihypertensives if possible.

Infant Risk: Low to moderate; potential for decreased milk supply, and theoretical risk of electrolyte imbalance or other effects in the infant, though typically not significant with usual doses.
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Pediatric Use

Safety and efficacy are not well-established for routine pediatric use. Use is generally off-label and requires careful consideration of risks vs. benefits, with close monitoring of electrolytes and renal function.

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Geriatric Use

Elderly patients may be more sensitive to the effects of chlorthalidone, particularly regarding electrolyte imbalances (hypokalemia, hyponatremia) and orthostatic hypotension. Lower initial doses and careful titration are recommended. Close monitoring of electrolytes and renal function is crucial.

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 more sustained blood pressure control with once-daily dosing.
  • It is considered by many guidelines (e.g., JNC 8, ACC/AHA) as a preferred thiazide-type diuretic for hypertension due to its superior evidence base for cardiovascular outcome reduction compared to hydrochlorothiazide.
  • Administer in the morning to prevent nocturia (nighttime urination).
  • Patients should be advised about the importance of maintaining adequate hydration and monitoring for symptoms of electrolyte imbalance, especially hypokalemia.
  • Caution should be exercised in patients with a history of gout or hyperuricemia, as chlorthalidone can exacerbate these conditions.
  • Not effective in patients with severe renal impairment (CrCl < 30 mL/min); loop diuretics are preferred in this setting.
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Alternative Therapies

  • Other Thiazide Diuretics (e.g., Hydrochlorothiazide, Indapamide, Metolazone)
  • Loop Diuretics (e.g., Furosemide, Torsemide, Bumetanide) - for more potent diuresis, especially in renal impairment or heart failure.
  • Potassium-Sparing Diuretics (e.g., Spironolactone, Amiloride, Triamterene) - often used in combination to counteract potassium loss.
  • Other Antihypertensive Classes (e.g., ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers) - depending on patient comorbidities and specific indications.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 25mg-50mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (Non-Preferred Generic) on most formularies.
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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.