Demadex 5mg Tablets

Manufacturer MEDA PHARMACEUTICALS 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 your blood pressure and reduce swelling (edema) in your body, especially in your legs, ankles, and lungs, which can be caused by conditions like heart failure, kidney disease, or liver problems.
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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. This medication may increase the frequency of urination, so try to avoid taking it too close to bedtime to minimize sleep disturbances.

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

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. If you have questions about disposing of your medication, consult with your pharmacist. 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 is 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 dose.
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Lifestyle & Tips

  • Take torsemide 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 better.
  • Monitor your weight daily and report any sudden changes (e.g., gain or loss of more than 2-3 pounds in a day) to your doctor.
  • Follow your doctor's recommendations for dietary salt intake. Limiting salt can help the medication work better.
  • Be aware of signs of dehydration (e.g., excessive thirst, dry mouth, dizziness) and electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat). Report these to your doctor.
  • Avoid standing up too quickly, especially when starting the medication, to prevent dizziness or lightheadedness.
  • Limit alcohol consumption, as it can increase the risk of dizziness and low blood pressure.
  • Inform your doctor or pharmacist about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: For hypertension: 5 mg PO once daily. For edema (CHF, renal, hepatic): 10-20 mg PO once daily.
Dose Range: 5 - 200 mg

Condition-Specific Dosing:

Hypertension: Initial 5 mg PO once daily; may increase to 10 mg PO once daily after 4-6 weeks if needed.
Edema (Congestive Heart Failure): Initial 10-20 mg PO once daily; may be titrated up to 200 mg PO once daily.
Edema (Renal Disease): Initial 20 mg PO once daily; may be titrated up to 200 mg PO once daily.
Edema (Hepatic Cirrhosis): Initial 5-10 mg PO once daily, administered with an aldosterone antagonist; may be titrated up to 40 mg PO once daily.
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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 specific adjustment needed.
Moderate: No specific adjustment needed, but monitor closely.
Severe: No specific adjustment needed, but higher doses (up to 200 mg/day) may be required for diuretic effect. Monitor closely for electrolyte imbalances.
Dialysis: Torsemide is not significantly removed by hemodialysis. No specific dose adjustment for patients on dialysis, but monitor fluid status and electrolytes.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution. Lower initial doses (e.g., 5-10 mg/day for edema) and careful titration are recommended. Monitor for electrolyte and fluid imbalances, and hepatic encephalopathy.
Severe: Use with caution. Lower initial doses and careful titration are recommended. Increased risk of electrolyte imbalances and hepatic encephalopathy.

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. It inhibits the Na+/K+/2Cl- cotransport system (NKCC2), thereby decreasing the reabsorption of sodium, potassium, and chloride ions. This leads to increased excretion of water, sodium, chloride, and potassium, resulting in diuresis and natriuresis. It also has a mild venodilatory effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90%
Tmax: 1 hour
FoodEffect: Food delays the time to peak concentration (Tmax) by approximately 30 minutes but does not affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 12-18 L
ProteinBinding: >98% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 3.5 hours (in healthy subjects)
Clearance: Total body clearance is approximately 40 mL/min
ExcretionRoute: Renal (20-25% unchanged drug), Hepatic (metabolites)
Unchanged: Approximately 20-25%
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Pharmacodynamics

OnsetOfAction: Within 1 hour (oral)
PeakEffect: 1-2 hours
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
+ Unable to pass urine or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of kidney problems, including:
+ Unable to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Ringing in the ears
* Hearing loss (although rare, this may occur, especially in people with kidney problems or those taking 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 an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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
  • Muscle cramps or weakness
  • Irregular heartbeat
  • Unusual tiredness or confusion
  • Excessive thirst or dry mouth
  • Nausea or vomiting that doesn't go away
  • Significant decrease in urination
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • 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 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.
If you have been diagnosed with liver disease.
If you are taking any medications that may increase the risk of hearing problems. There are numerous drugs that can cause this issue, so consult your doctor or pharmacist if you are unsure.

Additionally, to avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking.
Any natural products or vitamins you are using.
* Your medical history, including any health problems.

It is crucial to verify that this medication is safe to take with all your other medications and health conditions. 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.

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 exercise caution when climbing stairs.

If you have diabetes, closely monitor your blood sugar levels as directed by your healthcare provider. Regularly check your blood pressure as advised, and undergo blood tests as scheduled by your doctor. Discuss any concerns or questions with your doctor.

If you follow a low-sodium or sodium-free diet, consult your doctor. Additionally, if you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter 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 supplements.

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 individual requirements. You may require potassium supplements; discuss this with your doctor.

Notify your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, 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, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis (excessive urination)
  • Dehydration
  • Electrolyte depletion (especially hypokalemia, hyponatremia, hypochloremia)
  • Hypotension (low blood pressure)
  • Circulatory collapse
  • Thrombosis and embolism (due to hemoconcentration)

What to Do:

Seek immediate medical attention. Management is primarily supportive, focusing on fluid and electrolyte replacement. Induce emesis or perform gastric lavage if ingestion is recent. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Aminoglycosides (increased ototoxicity and nephrotoxicity)
  • Cisplatin (increased ototoxicity and nephrotoxicity)
  • Lithium (decreased renal clearance of lithium, leading to increased lithium levels and toxicity)
  • NSAIDs (e.g., ibuprofen, naproxen; may reduce diuretic and antihypertensive effects of torsemide)
  • Probenecid (may decrease renal secretion of torsemide, reducing its diuretic effect)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia)
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Moderate Interactions

  • Corticosteroids (increased risk of hypokalemia)
  • Amphotericin B (increased risk of hypokalemia)
  • Other antihypertensives (additive hypotensive effects)
  • Neuromuscular blockers (prolonged blockade due to hypokalemia)
  • Sucralfate (may reduce absorption of torsemide; administer torsemide 2 hours before sucralfate)
  • Cholestyramine (may reduce absorption of torsemide; administer torsemide 2 hours before cholestyramine)
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Minor Interactions

  • Warfarin (potential for minor displacement from protein binding, but usually not clinically significant)

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)

Rationale: To assess baseline kidney function, as torsemide is renally excreted and its efficacy can be affected by renal impairment.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and guide therapy for hypertension or assess risk of hypotension.

Timing: Prior to initiation of therapy.

Fluid Status (Weight, Edema assessment)

Rationale: To establish baseline and monitor response to diuretic therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Potassium, Sodium, Magnesium)

Frequency: Weekly for the first few weeks, then monthly or as clinically indicated, especially after dose changes or in patients with renal/hepatic impairment.

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

Action Threshold: Potassium < 3.5 mEq/L or > 5.5 mEq/L; Sodium < 130 mEq/L or > 150 mEq/L; Magnesium < 1.5 mg/dL. Requires intervention (supplementation, dose adjustment, or discontinuation).

Renal Function (BUN, Serum Creatinine)

Frequency: Monthly or as clinically indicated, especially in patients with pre-existing renal impairment or those on concomitant nephrotoxic drugs.

Target: Within patient's baseline or normal limits.

Action Threshold: Significant increase in BUN or creatinine (e.g., >25% from baseline or above upper limit of normal). Requires investigation and potential dose adjustment.

Blood Pressure

Frequency: Regularly, especially during initial titration and with dose changes.

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

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

Fluid Status (Daily Weight, Edema, Urine Output)

Frequency: Daily (weight) for patients with edema, or as clinically indicated.

Target: Stable weight, reduction in edema, adequate urine output.

Action Threshold: Rapid weight loss (>2-3 lbs/day), signs of dehydration (dry mucous membranes, orthostasis), or persistent/worsening edema.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized.

Action Threshold: Significant hyperglycemia.

Uric Acid

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

Target: Within normal limits.

Action Threshold: Significant hyperuricemia or symptoms of gout.

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Symptom Monitoring

  • Dizziness or lightheadedness (signs of hypotension or dehydration)
  • Muscle cramps or weakness (signs of hypokalemia or hypomagnesemia)
  • Excessive thirst or dry mouth (signs of dehydration)
  • Nausea or vomiting
  • Fatigue or lethargy
  • Changes in urination (too much or too little)
  • Swelling in ankles, feet, or legs (if edema persists or worsens)
  • Signs of gout (joint pain, swelling, redness)

Special Patient Groups

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Pregnancy

Torsemide is classified as Pregnancy Category B. Animal studies have not shown evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Generally considered low risk based on animal data, but human data is limited. Avoid if possible unless essential.
Second Trimester: May be used if clinically indicated, with careful monitoring of maternal fluid and electrolyte status.
Third Trimester: Use with caution. Diuretics can decrease plasma volume and placental perfusion, potentially leading to fetal growth restriction. Risk of neonatal thrombocytopenia has been reported with thiazide diuretics, but less clear with loop diuretics.
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Lactation

Torsemide is excreted in breast milk. The amount is generally considered small, and the risk to the infant is likely low (L3 - Moderately Safe). However, caution is advised. Monitor the infant for signs of dehydration, electrolyte imbalance, or decreased weight gain. Maternal milk production may also be reduced.

Infant Risk: Low to moderate risk. Monitor for dehydration, electrolyte disturbances, and adequate weight gain. Consider alternative if infant is premature or has underlying conditions.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in children.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients may be more sensitive to the effects of diuretics and more prone to dehydration and electrolyte imbalances. Start with lower doses and titrate carefully. Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • Torsemide has a higher and more consistent oral bioavailability compared to furosemide, making it a preferred choice for some patients.
  • Administer torsemide in the morning to prevent nocturia (nighttime urination).
  • Unlike furosemide, torsemide's efficacy is less affected by renal impairment, making it a useful option in patients with reduced kidney function.
  • Always monitor electrolytes, especially potassium, as hypokalemia is a common side effect of loop diuretics. Potassium supplementation or potassium-sparing diuretics may be needed.
  • Educate patients on the importance of daily weight monitoring as a key indicator of fluid status.
  • In patients with hepatic cirrhosis, torsemide should always be used in conjunction with an aldosterone antagonist (e.g., spironolactone) to prevent hypokalemia and minimize the risk of hepatic encephalopathy.
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Alternative Therapies

  • Furosemide (another loop diuretic)
  • Bumetanide (another loop diuretic)
  • Ethacrynic acid (another loop diuretic, used for patients with sulfa allergy)
  • Hydrochlorothiazide (thiazide diuretic, for hypertension or mild edema)
  • Chlorthalidone (thiazide-like diuretic, for hypertension)
  • Metolazone (thiazide-like diuretic, often used in combination with loop diuretics for refractory edema)
  • Spironolactone (potassium-sparing diuretic, often used in heart failure or hepatic cirrhosis)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (5mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.