Demadex 20mg Tablets

Manufacturer MEDA Active Ingredient Torsemide(TORE se mide) Pronunciation TORE se mide
It is used to get rid of extra fluid. It is used to treat high blood pressure.
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Drug Class
Diuretic, Antihypertensive
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Pharmacologic Class
Loop Diuretic
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Pregnancy Category
Category B
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FDA Approved
Dec 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Torsemide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water. This can help lower high blood pressure and reduce swelling (edema) caused by conditions like heart failure, kidney disease, or liver disease.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. This medication may increase your urine production, so try to avoid taking it too close to bedtime to minimize sleep disruptions.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. If you're also taking cholestyramine, consult with your pharmacist to determine the best way to take these medications together.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity. Keep all medications in a secure location, out of reach of children and pets.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire about potential 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. Avoid taking two doses at the same time or taking extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Follow a low-sodium diet as advised by your doctor or dietitian.
  • Monitor your weight daily, preferably at the same time each day, and report any sudden changes (e.g., gain or loss of 2-3 pounds in a day) to your doctor.
  • Limit alcohol intake as it can worsen dehydration and lower blood pressure.
  • Avoid standing up too quickly to prevent dizziness or lightheadedness.
  • Stay hydrated as advised by your doctor; do not restrict fluids unless specifically instructed.
  • Take the medication in the morning to avoid frequent urination at night.

Dosing & Administration

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Adult Dosing

Standard Dose: Edema: 10-20 mg orally or intravenously once daily. Hypertension: 5 mg orally once daily.
Dose Range: 5 - 200 mg

Condition-Specific Dosing:

edema_congestive_heart_failure: Initial 10-20 mg PO/IV once daily; titrate up to 200 mg/day if needed.
edema_renal_disease: Initial 20 mg PO/IV once daily; titrate up to 200 mg/day if needed.
edema_hepatic_cirrhosis: Initial 10 mg PO/IV once daily; titrate up to 20 mg/day if needed (use with aldosterone antagonist).
hypertension: Initial 5 mg PO once daily; may increase to 10 mg/day after 4-6 weeks if needed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, individualized dosing for specific conditions like CHF or renal failure, typically 0.1-0.4 mg/kg/day)
Adolescent: Not established (limited data, individualized dosing)
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment, monitor closely.
Moderate: No initial dose adjustment, monitor closely. Higher doses (e.g., 20-200 mg/day) may be required for diuresis in severe renal impairment.
Severe: Higher doses (e.g., 20-200 mg/day) may be required for diuresis. Monitor fluid and electrolyte status closely.
Dialysis: Not significantly dialyzable. Higher doses may be needed for fluid removal in patients on dialysis; monitor closely for fluid and electrolyte balance.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution. Lower initial doses may be considered. Increased risk of electrolyte imbalance and hepatic encephalopathy.
Severe: Use with extreme caution. Contraindicated in hepatic coma or pre-coma. Monitor fluid, electrolytes, and mental status closely.

Pharmacology

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Mechanism of Action

Torsemide is a loop diuretic that acts on the thick ascending limb of the loop of Henle, where it inhibits the Na+/K+/2Cl- cotransporter (NKCC2). This inhibition prevents the reabsorption of sodium, potassium, and chloride, leading to increased excretion of water, sodium, chloride, and potassium. It also has a mild venodilatory effect.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1 hour (oral)
FoodEffect: Minimal impact on absorption rate or extent.

Distribution:

Vd: Approximately 12-15 L
ProteinBinding: >95% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 3.5 hours
Clearance: Total plasma clearance approximately 40 mL/min/kg
ExcretionRoute: Renal (20-25% as unchanged drug), Hepatic (75-80% as metabolites)
Unchanged: 20-25%
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Pharmacodynamics

OnsetOfAction: Oral: 60 minutes; Intravenous: 10 minutes
PeakEffect: Oral: 1-2 hours; Intravenous: 1 hour
DurationOfAction: 6-8 hours

Safety & Warnings

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Side Effects

Urgent 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 or seek immediate 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
+ Difficulty urinating or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of kidney problems, including:
+ Difficulty urinating
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Ringing in the ears (tinnitus)
* Hearing loss (which is rare, but may be more likely if you have kidney problems or take high doses of this medication)

If you experience any hearing problems, such as hearing loss, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical attention.

This is not a comprehensive list of all 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, lightheadedness, or fainting
  • Signs of dehydration: extreme thirst, dry mouth, decreased urination, dark urine
  • Signs of electrolyte imbalance: muscle cramps, weakness, irregular heartbeat, confusion
  • Unusual tiredness or weakness
  • Nausea or vomiting that doesn't go away
  • New or worsening swelling in your legs, ankles, or feet
  • Difficulty breathing or shortness of breath
  • Ringing in your ears or hearing loss (rare, but report immediately)
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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.
If you have difficulty urinating or are unable to pass urine.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you are taking any medications that can increase the risk of hearing problems. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.

To avoid potential interactions and ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:

A comprehensive list of all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have, as these may affect the medication's safety and efficacy.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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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, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

If you have diabetes (high blood sugar), closely monitor your blood sugar levels as advised by your healthcare provider. Regularly check your blood pressure as directed, and have your blood work checked according to your doctor's instructions. Discuss any concerns or questions with your doctor.

If you are on a low-sodium or sodium-free diet, consult your doctor. Additionally, if you have high blood pressure and are taking this medication, talk to 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.

This medication is a potent diuretic, which can lead to excessive loss of water and electrolytes (including potassium) in the blood, potentially causing severe health issues. Your doctor will closely monitor you and adjust the dosage as needed to meet your body's requirements. You may need to take extra potassium; discuss this with your doctor.

If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions can lead to low blood pressure. Be aware of the possibility of gout attacks and report any symptoms to your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis leading to dehydration and electrolyte depletion (e.g., hypokalemia, hyponatremia, hypochloremia)
  • Hypotension (low blood pressure)
  • Cardiovascular collapse
  • Hemoconcentration

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 to correct imbalances and maintain blood pressure.

Drug Interactions

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Contraindicated Interactions

  • Anuria (due to lack of efficacy)
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Major Interactions

  • Aminoglycosides (increased risk of ototoxicity and nephrotoxicity)
  • Cisplatin (increased risk of ototoxicity)
  • NSAIDs (e.g., ibuprofen, naproxen; may reduce diuretic and antihypertensive effects, increase risk of renal impairment)
  • Lithium (decreased renal clearance of lithium, leading to increased lithium levels and toxicity)
  • Digoxin (hypokalemia induced by torsemide can potentiate digoxin toxicity)
  • ACE inhibitors/ARBs/Aliskiren (increased risk of severe hypotension and renal dysfunction, especially with initial doses)
  • Other antihypertensives (additive hypotensive effects)
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Moderate Interactions

  • Corticosteroids (increased risk of hypokalemia)
  • Amphotericin B (increased risk of hypokalemia)
  • Sucralfate (may decrease absorption of torsemide; separate administration by at least 2 hours)
  • Probenecid (may decrease diuretic effect of torsemide)
  • Cholestyramine (may decrease absorption of torsemide)
  • Phenytoin (may decrease diuretic effect of torsemide)
  • Warfarin (torsemide may displace warfarin from protein binding sites, potentially increasing anticoagulant effect; monitor INR)
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Minor Interactions

  • None specifically categorized as minor with significant clinical impact.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Magnesium, Calcium)

Rationale: To establish baseline levels and identify pre-existing imbalances, as torsemide can cause electrolyte disturbances.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function and guide dosing, as well as monitor for potential renal impairment.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for hypotensive effects.

Timing: Prior to initiation of therapy.

Fluid Status (Weight, Edema, Lung Sounds)

Rationale: To assess baseline volume status and monitor therapeutic response.

Timing: Prior to initiation of therapy.

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: Especially in patients with suspected or known hepatic impairment, due to hepatic metabolism and risk of encephalopathy.

Timing: Prior to initiation of therapy in relevant patients.

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Routine Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride)

Frequency: Weekly for the first few weeks, then monthly or as clinically indicated.

Target: Sodium: 135-145 mEq/L; Potassium: 3.5-5.0 mEq/L; Chloride: 98-107 mEq/L

Action Threshold: Potassium < 3.0 mEq/L or > 5.5 mEq/L; Sodium < 130 mEq/L; significant changes from baseline.

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically, or more frequently with dose changes or in patients with renal impairment.

Target: Within normal limits for patient's age/sex; stable.

Action Threshold: Significant increase in BUN/Creatinine (e.g., >25% increase from baseline or above upper limit of normal).

Blood Pressure

Frequency: Daily (patient self-monitoring) or at each clinic visit.

Target: Individualized based on condition (e.g., <130/80 mmHg for hypertension).

Action Threshold: Symptomatic hypotension (e.g., dizziness, syncope) or systolic BP < 90 mmHg.

Weight

Frequency: Daily (patient self-monitoring).

Target: Stable, or target weight as determined by clinician.

Action Threshold: Rapid weight loss (>2-3 lbs/day) or gain, indicating over-diuresis or inadequate diuresis.

Fluid Status (Edema, Lung Sounds, Urine Output)

Frequency: Daily (patient self-monitoring for edema/urine output), at each clinic visit (physical exam).

Target: Resolution of edema, clear lung sounds, adequate urine output.

Action Threshold: Persistent or worsening edema, signs of dehydration (dry mucous membranes, decreased skin turgor), oliguria.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Excessive thirst or dry mouth
  • Muscle cramps or weakness
  • Irregular heartbeat (palpitations)
  • Nausea or vomiting
  • Unusual tiredness or fatigue
  • Changes in hearing (rare, but possible with high doses or rapid IV administration)
  • Signs of dehydration (decreased urination, dark urine, sunken eyes)
  • Signs of worsening edema (increased swelling, shortness of breath)

Special Patient Groups

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Pregnancy

Category B. Animal studies have shown no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital anomalies observed in animal studies.
Second Trimester: No specific risks identified beyond general diuretic use considerations.
Third Trimester: Diuretics can reduce plasma volume and placental perfusion, potentially causing fetal growth restriction. Not recommended for routine use in healthy pregnant women with mild edema.
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Lactation

L3 (Moderately Safe). Torsemide is excreted in the milk of lactating rats. It is unknown if torsemide is excreted in human milk. Due to the potential for serious adverse reactions in the nursing infant (e.g., dehydration, electrolyte imbalance), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Potential for dehydration, electrolyte imbalance, and inhibition of lactation. Monitor infant for signs of fluid/electrolyte disturbances.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended. If used, dosing must be individualized and closely monitored due to potential for severe fluid and electrolyte disturbances.

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Geriatric Use

Elderly patients may be more susceptible to the effects of torsemide, particularly fluid and electrolyte imbalances (e.g., hypokalemia, hyponatremia, dehydration) and orthostatic hypotension. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Torsemide has a longer duration of action and higher bioavailability compared to furosemide, allowing for once-daily dosing and more predictable absorption.
  • It is generally considered less ototoxic than furosemide, especially with rapid IV administration.
  • Torsemide can be effective in patients with impaired renal function where thiazide diuretics may be less effective.
  • Patients should be advised to take torsemide in the morning to prevent nocturia (waking up to urinate at night).
  • Close monitoring of electrolytes (especially potassium) and renal function is crucial, particularly during initiation of therapy and dose adjustments.
  • In patients with hepatic cirrhosis, torsemide should be used with caution and often in combination with an aldosterone antagonist (e.g., spironolactone) to prevent hypokalemia and metabolic alkalosis, and to reduce the risk of hepatic encephalopathy.
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Alternative Therapies

  • Other Loop Diuretics (e.g., Furosemide, Bumetanide, Ethacrynic acid)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone, Indapamide)
  • Potassium-Sparing Diuretics (e.g., Spironolactone, Eplerenone, Amiloride, Triamterene)
  • For Hypertension: ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers, etc.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 20mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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.