Demadex 100mg (hundred Mg) Tab

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
Loop Diuretic
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Pharmacologic Class
Sulfonamide-derived 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, 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 well.

If you are also taking cholestyramine, consult with your pharmacist about the best way to take these medications together.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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's close to the time for your next dose, skip the missed dose and resume your regular 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 exactly as prescribed, usually once daily in the morning to avoid nighttime urination.
  • Do not stop taking 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 (gain or loss) to your doctor.
  • Be aware of signs of dehydration (e.g., excessive thirst, dizziness) and electrolyte imbalance (e.g., muscle cramps, weakness).
  • Avoid standing up too quickly to prevent dizziness or lightheadedness.
  • Limit alcohol consumption as it can increase the risk of dizziness and low blood pressure.
  • Discuss any new medications, including over-the-counter drugs and herbal supplements, with your doctor or pharmacist.

Dosing & Administration

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Adult Dosing

Standard Dose: For edema associated with CHF, renal, or hepatic disease: Initial 10-20 mg once daily. For hypertension: Initial 5 mg once daily.
Dose Range: 5 - 200 mg

Condition-Specific Dosing:

edema_CHF: 20 mg once daily, titrate up to 200 mg/day if needed.
edema_renal: 20 mg once daily, titrate up to 200 mg/day if needed.
edema_hepatic: 5-10 mg once daily, titrate up to 40 mg/day if needed. Use with aldosterone antagonist or potassium-sparing diuretic.
hypertension: 5 mg once daily, titrate up to 10 mg once daily after 4-6 weeks if needed. Higher doses not recommended for hypertension.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, off-label use may occur in specific conditions under specialist supervision)
Adolescent: Not established (limited data, off-label use may occur in specific conditions under specialist supervision)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor closely.
Severe: Initial 20 mg once daily, may increase to 200 mg once daily if needed for diuresis. Monitor closely for fluid and electrolyte imbalances.
Dialysis: Torsemide is not significantly removed by hemodialysis. Dosing adjustments may be needed based on residual renal function and fluid status.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution. Start with lower doses (e.g., 5-10 mg daily) and titrate slowly. Increased risk of hepatic coma.
Severe: Use with extreme caution. Start with lower doses (e.g., 5-10 mg daily) and titrate slowly. Increased risk of hepatic coma. Consider concomitant potassium-sparing diuretic.

Pharmacology

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Mechanism of Action

Torsemide is a loop diuretic that acts from within the lumen of the thick ascending limb of the loop of Henle, where it inhibits the Na+/K+/2Cl- carrier system. This inhibition reduces the reabsorption of sodium, potassium, and chloride, leading to increased excretion of water, sodium, chloride, and potassium. It also has a mild aldosterone antagonist effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90%
Tmax: Approximately 1 hour
FoodEffect: Food delays the rate (Tmax) but not the extent (AUC) of absorption.

Distribution:

Vd: Approximately 12-15 liters
ProteinBinding: Greater than 99%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 3.5 hours (range 2.1-5.7 hours)
Clearance: Approximately 40 mL/min
ExcretionRoute: Renal (approximately 20% unchanged drug, 80% metabolites)
Unchanged: Approximately 20%
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Pharmacodynamics

OnsetOfAction: Within 1 hour (oral)
PeakEffect: Within 1-2 hours
DurationOfAction: Approximately 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 (tinnitus)
* Hearing loss, which is rare but may occur, especially in people with kidney problems or those taking high doses of this medication. If you experience hearing problems, contact your doctor immediately.

Other Possible Side Effects

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

Not all possible side effects are listed here. 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
  • Signs of dehydration (e.g., extreme thirst, dry mouth, decreased urination)
  • Signs of electrolyte imbalance (e.g., severe muscle cramps, unusual weakness, irregular heartbeat, confusion, seizures)
  • Sudden hearing loss or ringing in the ears (tinnitus)
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe stomach pain with nausea or vomiting
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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 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 ask 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 medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems

It is crucial to verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 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, 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 supplemental potassium; 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis leading to severe dehydration and electrolyte depletion (e.g., hypokalemia, hyponatremia, hypochloremia)
  • Hypotension (low blood pressure)
  • Cardiovascular collapse
  • Hemoconcentration
  • Thrombosis
  • Acute renal failure
  • Lethargy, confusion, coma (especially with hepatic impairment)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is primarily supportive, focusing on fluid and electrolyte replacement. Induce emesis or gastric lavage if ingestion is recent. Monitor vital signs, fluid balance, and electrolytes closely.

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 (may reduce diuretic and antihypertensive effects of torsemide)
  • Probenecid (may reduce diuretic effect of torsemide)
  • Sucralfate (may reduce absorption of torsemide)
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Moderate Interactions

  • ACE inhibitors/ARBs (increased risk of hypotension and renal dysfunction, especially with initial doses)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia)
  • Corticosteroids (increased risk of hypokalemia)
  • Amphotericin B (increased risk of hypokalemia)
  • Other antihypertensives (additive hypotensive effects)
  • Neuromuscular blockers (potentiated effect due to hypokalemia)
  • Antidiabetic agents (may decrease hypoglycemic effect)
  • Warfarin (no significant interaction reported, but monitor INR)
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Minor Interactions

  • Cholestyramine (may reduce absorption of torsemide if given concurrently)

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 significant electrolyte disturbances.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function, which influences dosing and risk of adverse effects.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for excessive hypotension.

Timing: Prior to initiation of therapy.

Body Weight

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

Timing: Prior to initiation of therapy.

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: Especially important in patients with pre-existing hepatic impairment due to risk of hepatic coma.

Timing: Prior to initiation of therapy in patients with suspected or known liver disease.

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Routine Monitoring

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

Frequency: Weekly initially, then monthly or as clinically indicated, especially after dose changes or in patients with unstable conditions.

Target: Within normal limits (e.g., K+ 3.5-5.0 mEq/L)

Action Threshold: Significant deviations (e.g., K+ < 3.0 mEq/L or > 5.5 mEq/L), symptomatic electrolyte imbalance.

Renal Function (BUN, Serum Creatinine, eGFR)

Frequency: Weekly initially, then monthly or as clinically indicated, especially after dose changes or in patients with unstable conditions.

Target: Stable or improving

Action Threshold: Significant increase in BUN/Creatinine, decrease in eGFR, or signs of acute kidney injury.

Blood Pressure

Frequency: Daily or as clinically indicated, especially during dose titration.

Target: Individualized target (e.g., <130/80 mmHg for hypertension, avoid symptomatic hypotension)

Action Threshold: Symptomatic hypotension, systolic BP < 90 mmHg, or significant drop from baseline.

Body Weight

Frequency: Daily (for acute fluid management) or weekly (for chronic management).

Target: Stable or desired weight loss (e.g., 1-2 lbs/day for acute edema)

Action Threshold: Rapid weight gain (fluid retention) or excessive weight loss (dehydration).

Fluid Status (edema, lung sounds, urine output)

Frequency: Daily or as clinically indicated.

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

Action Threshold: Persistent or worsening edema, crackles in lungs, oliguria, or signs of dehydration.

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Symptom Monitoring

  • Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness, weakness)
  • Symptoms of electrolyte imbalance (muscle cramps, weakness, fatigue, irregular heartbeats, nausea, vomiting, confusion, seizures)
  • Signs of ototoxicity (hearing loss, tinnitus, vertigo)
  • Symptoms of gout (joint pain, swelling, redness)
  • Symptoms of hyperglycemia (increased thirst, urination, hunger)
  • Symptoms of hepatic encephalopathy (confusion, lethargy, asterixis) in patients with liver disease

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: No specific increased risk identified in animal studies, but human data are limited.
Second Trimester: No specific increased risk identified in animal studies, but human data are limited.
Third Trimester: Diuretics may decrease plasma volume and placental perfusion, potentially causing fetal growth retardation. Not recommended for routine use in healthy pregnant women with mild edema.
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Lactation

It is not known whether torsemide is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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 (Moderate risk - no human data, but potential for adverse effects on infant or milk production based on drug properties or animal data).
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended. If used off-label, close monitoring of fluid and electrolytes is crucial.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the hypotensive and electrolyte-depleting effects of diuretics and should be monitored closely. Start with lower doses and titrate carefully.

Clinical Information

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Clinical Pearls

  • Torsemide has a longer half-life and duration of action compared to furosemide, allowing for once-daily dosing.
  • Its bioavailability is more consistent than furosemide, making it a good option for patients with variable absorption.
  • Unlike furosemide, torsemide's absorption is not significantly affected by food.
  • Monitor for hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic alkalosis. Potassium supplementation or co-administration with a potassium-sparing diuretic may be necessary.
  • In patients with hepatic cirrhosis, torsemide should be used with caution and often in combination with an aldosterone antagonist to prevent hypokalemia and metabolic alkalosis, which can precipitate hepatic encephalopathy.
  • Patients should be advised to take the medication in the morning to avoid nocturia.
  • High doses (e.g., 100mg or 200mg) are typically reserved for severe edema refractory to lower doses or other diuretics, particularly in renal failure.
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Alternative Therapies

  • Furosemide (Lasix)
  • Bumetanide (Bumex)
  • Ethacrynic acid (Edecrin) - for patients with sulfonamide allergy
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone) - for hypertension or milder edema, often used in combination with loop diuretics for refractory edema.
  • Potassium-sparing diuretics (e.g., spironolactone, eplerenone, amiloride, triamterene) - often used in combination with loop diuretics to counteract potassium loss.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (for generic Torsemide 100mg)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.