Demadex 10mg 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
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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 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 disturbances.

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 effectiveness 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 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 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 adverse effects.
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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.
  • Follow your doctor's recommendations for diet, especially regarding salt intake.
  • 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.
  • Avoid excessive alcohol consumption, as it can increase the risk of dizziness and dehydration.
  • Be cautious when standing up quickly, as you may experience dizziness (orthostatic hypotension).

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication: Edema (CHF): 10-20 mg PO once daily; Hypertension: 2.5-5 mg PO once daily
Dose Range: 2.5 - 200 mg

Condition-Specific Dosing:

edema_heart_failure: Initial 10-20 mg PO once daily; may be titrated up to 200 mg/day.
edema_renal_disease: Initial 20 mg PO once daily; may be titrated up to 200 mg/day.
edema_hepatic_cirrhosis: Initial 5-10 mg PO once daily, administered with an aldosterone antagonist; may be titrated up to 40 mg/day.
hypertension: Initial 2.5-5 mg PO once daily; if response is inadequate after 4-6 weeks, dose may be increased to 10 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, generally not recommended)
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 monitor closely. Maximum dose of 200 mg/day is generally effective.
Dialysis: Torsemide is not significantly dialyzable. No supplemental dose needed after dialysis, but monitor fluid and electrolyte status.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; lower initial doses (e.g., 5-10 mg/day for edema due to hepatic cirrhosis) and monitor closely for electrolyte and fluid imbalances.
Severe: Use with caution; lower initial doses and monitor closely. Risk of hepatic coma.

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- cotransport system. This inhibition leads to increased excretion of sodium, chloride, and water, as well as potassium, calcium, and magnesium.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 12-18 L
ProteinBinding: >98%
CnssPenetration: Limited

Elimination:

HalfLife: 3.5 hours (range 2.5-4 hours)
Clearance: Approximately 40 mL/min (renal) and 10 mL/min (hepatic)
ExcretionRoute: Renal (unchanged drug and metabolites), Hepatic (metabolites)
Unchanged: Approximately 20%
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 1-2 hours
DurationOfAction: 6-8 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of kidney problems, including:
+ Unable to pass urine
+ Changes in urine production
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or passing out
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 right away.

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any symptoms that bother you or persist.

This is not an exhaustive list of potential 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
  • Muscle cramps, weakness, or spasms
  • Unusual tiredness or confusion
  • Irregular or fast heartbeat
  • Severe nausea or vomiting
  • Dry mouth, increased thirst, or decreased urination (signs of dehydration)
  • Ringing in the ears or hearing loss
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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 several medications that can cause this issue, so consult your doctor or pharmacist if you are unsure.

To avoid potential interactions, it is crucial to discuss all of your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change 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, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

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

If you are on a low-sodium diet, consult with 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 and 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, resulting in severe health issues. Your doctor will closely monitor you and adjust the dosage as needed to meet your individual requirements. You may need to take additional 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 potential for gout attacks while taking this medication.

If you are pregnant, planning to become pregnant, or breastfeeding, inform 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 (excessive urination)
  • Severe dehydration
  • Electrolyte depletion (e.g., hypokalemia, hyponatremia)
  • Hypotension (low blood pressure)
  • Cardiovascular collapse
  • Thrombosis and embolism (due to hemoconcentration)

What to Do:

Seek immediate medical attention. Management is primarily supportive, focusing on fluid and electrolyte replacement. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Aminoglycosides (increased ototoxicity)
  • Cisplatin (increased ototoxicity)
  • Lithium (increased lithium levels and toxicity due to reduced renal clearance)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia)
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Moderate Interactions

  • NSAIDs (reduced diuretic and antihypertensive effect, increased risk of renal impairment)
  • Corticosteroids (increased risk of hypokalemia)
  • Amphotericin B (increased risk of hypokalemia)
  • Other antihypertensives (additive hypotensive effect)
  • Probenecid (decreased torsemide secretion, reduced diuretic effect)
  • Cholestyramine (reduced torsemide absorption)
  • Warfarin (potential for altered anticoagulant effect, monitor INR)
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Minor Interactions

  • Not available

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 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.

Weight and Fluid Status

Rationale: To establish baseline and monitor for efficacy (fluid removal) and signs of dehydration.

Timing: Prior to initiation of therapy.

Serum Uric Acid

Rationale: Torsemide can increase uric acid levels.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Potassium, Sodium, Magnesium)

Frequency: Weekly initially, then monthly or as clinically indicated, especially during dose titration or in patients with risk factors for electrolyte imbalance.

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 (consider supplementation), Sodium < 130 mEq/L (consider fluid restriction/dose adjustment), Magnesium < 1.7 mg/dL (consider supplementation).

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 range.

Action Threshold: Significant increase in BUN/creatinine (e.g., >25% above baseline or acute kidney injury criteria) may warrant dose adjustment or discontinuation.

Blood Pressure

Frequency: Regularly (e.g., daily at home, at each clinic visit).

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

Action Threshold: Symptomatic hypotension or persistent systolic BP < 90 mmHg.

Weight and Fluid Status

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

Target: Stable dry weight, absence of edema/signs of fluid overload.

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

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Muscle cramps or weakness
  • Excessive thirst or dry mouth
  • Nausea or vomiting
  • Unusual fatigue or lethargy
  • Irregular heartbeat
  • Hearing changes (tinnitus, hearing loss)

Special Patient Groups

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Pregnancy

Category B. Animal studies have shown no evidence of impaired fertility or fetal harm. However, 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: Generally considered low risk based on animal data, but human data are limited.
Second Trimester: Low risk, but monitor for maternal electrolyte imbalances.
Third Trimester: Use with caution; diuretics can reduce placental perfusion and may cause fetal/neonatal jaundice, thrombocytopenia, and other adverse reactions seen in adults.
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Lactation

Torsemide is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant (e.g., dehydration, electrolyte imbalance) and the potential for reduction in milk supply, 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: Moderate risk (L3). Potential for dehydration, electrolyte disturbances, and ototoxicity in the infant. Also, loop diuretics can suppress lactation.
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Pediatric Use

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

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Geriatric Use

No specific dose adjustment is required, but elderly patients may be more susceptible to the hypotensive and electrolyte-disturbing effects of diuretics. Start with lower doses and monitor closely for dehydration and electrolyte imbalances.

Clinical Information

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Clinical Pearls

  • Torsemide has a longer duration of action and higher oral bioavailability compared to furosemide, making it a good option for once-daily dosing.
  • Monitor potassium levels closely, especially in patients also taking digoxin, corticosteroids, or those with liver cirrhosis.
  • Patients should be advised to take torsemide in the morning to prevent nocturia (waking up to urinate at night).
  • While generally well-tolerated, ototoxicity (hearing impairment) can occur, especially with rapid IV administration or in patients with renal impairment or those receiving other ototoxic drugs.
  • For patients with hepatic cirrhosis, torsemide should always be used in conjunction with an aldosterone antagonist (e.g., spironolactone) to prevent hypokalemia and metabolic alkalosis.
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Alternative Therapies

  • Furosemide (another loop diuretic)
  • Bumetanide (another loop diuretic)
  • Ethacrynic acid (another loop diuretic, used for sulfa allergy)
  • Hydrochlorothiazide (thiazide diuretic, for hypertension or mild edema)
  • Spironolactone (potassium-sparing diuretic, often used with loop diuretics for heart failure/cirrhosis)
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Cost & Coverage

Average Cost: Varies widely, typically low for generic per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 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.