Furosemide 80mg Tablets

Manufacturer HIKMA /ROXANE Active Ingredient Furosemide Tablets(fyoor OH se mide) Pronunciation fyoor OH se mide
WARNING: This drug is a strong fluid-lowering drug (diuretic). Sometimes too much water and electrolytes (like potassium) in the blood may be lost. This can lead to severe health problems. Your doctor will follow you closely to change the dose to match your body's needs. @ COMMON USES: 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
C
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FDA Approved
Jun 1966
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Furosemide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water. This helps to reduce swelling (edema) and lower blood pressure. It works by making your kidneys remove more water and salt from your blood, which then leaves your body through urine.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You may notice that you need to urinate more frequently while taking this medication. To minimize sleep disturbances, try to avoid taking it too close to bedtime.

Important Interactions and Precautions

Do not take sucralfate within 2 hours before or after taking this medication. If the product changes color, do not take it.

Storing and Disposing of Your Medication

Keep your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Ensure that all medications are kept in a safe location, out of the 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. Consult your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available 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. 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 exactly as prescribed, usually once or twice daily. If taking twice daily, take the second dose in the late afternoon to avoid nighttime urination.
  • Do not stop taking without consulting your doctor, even if you feel better.
  • Monitor your weight daily and report any sudden changes (gain or loss) to your doctor.
  • Avoid excessive sun exposure as furosemide can increase sensitivity to sunlight.
  • Discuss dietary salt intake with your doctor. You may be advised to limit salt.
  • Discuss potassium intake with your doctor. You may need potassium supplements or to eat potassium-rich foods, or avoid them, depending on your blood levels.
  • Avoid alcohol, as it can increase the risk of dizziness or fainting.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness.

Dosing & Administration

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Adult Dosing

Standard Dose: Edema: 20 to 80 mg orally as a single dose. May be increased by 20 to 40 mg every 6 to 8 hours until desired diuretic effect is obtained. For severe edema, doses up to 600 mg/day have been used. Hypertension: 40 mg twice daily.
Dose Range: 20 - 600 mg

Condition-Specific Dosing:

edema: Initial 20-80 mg orally as a single dose. May be increased by 20-40 mg every 6-8 hours until desired diuretic effect is obtained. For severe edema, doses up to 600 mg/day have been used.
hypertension: 40 mg twice daily.
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Pediatric Dosing

Neonatal: Not established for routine use; use with caution. Initial 1 mg/kg/dose, then 1-2 mg/kg/dose every 12-24 hours. Max 6 mg/kg/day.
Infant: Initial 1-2 mg/kg/dose orally, once daily or every 12-24 hours. Max 6 mg/kg/day.
Child: Initial 1-2 mg/kg/dose orally, once daily or every 12-24 hours. Max 6 mg/kg/day.
Adolescent: Initial 1-2 mg/kg/dose orally, once daily or every 12-24 hours. Max 6 mg/kg/day. For severe edema, adult dosing may apply.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: Monitor closely; higher doses may be required to achieve diuresis. Max dose may be limited.
Severe: Monitor closely; higher doses may be required. Max dose 80-160 mg/day in severe renal failure. Risk of ototoxicity increases with high doses and rapid infusion.
Dialysis: Furosemide is not significantly removed by dialysis. Dosing may need to be adjusted based on residual renal function and fluid status. Often given post-dialysis if needed.

Hepatic Impairment:

Mild: Monitor closely for fluid and electrolyte imbalances.
Moderate: Monitor closely; reduced elimination may occur. Increased risk of hepatic encephalopathy due to electrolyte disturbances (e.g., hypokalemia).
Severe: Use with extreme caution. Increased risk of hepatic encephalopathy. Lower initial doses and slower titration may be necessary. Avoid if possible.

Pharmacology

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Mechanism of Action

Furosemide is a loop diuretic that inhibits the Na+-K+-2Cl- cotransporter in the thick ascending limb of the loop of Henle. This inhibition prevents the reabsorption of sodium, potassium, and chloride ions, leading to increased excretion of water, sodium, chloride, and potassium. It also has a direct vasodilatory effect on renal blood vessels, increasing renal blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: 40-70% (highly variable)
Tmax: Oral: 1-2 hours
FoodEffect: Food may decrease the rate but not the extent of absorption.

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: >95% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 0.5-2 hours (prolonged in renal/hepatic impairment)
Clearance: Not available
ExcretionRoute: Renal (primarily unchanged drug, 60-90%), fecal (10-15%)
Unchanged: 60-90%
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Pharmacodynamics

OnsetOfAction: Oral: 30-60 minutes
PeakEffect: Oral: 1-2 hours
DurationOfAction: Oral: 6-8 hours

Safety & Warnings

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BLACK BOX WARNING

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and the dosage must be individualized according to the patient's needs.
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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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, including:
+ Mood changes or 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 or dry eyes
+ Severe stomach upset or vomiting
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, including:
+ Difficulty urinating
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe stomach upset or vomiting
Severe dizziness or fainting
Abnormal sensations, such as burning, numbness, or tingling
Blurred vision
Restlessness

Severe Skin Reactions: Get Medical Help Right Away

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may affect other organs. Seek immediate medical attention if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

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 or headache
Constipation
Diarrhea
Stomach upset or vomiting
Decreased appetite
* Stomach cramps

Reporting Side Effects

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:

  • Signs of dehydration: severe thirst, very dry mouth, decreased urination, dizziness, lightheadedness, confusion, muscle cramps.
  • Signs of low potassium: muscle weakness, leg cramps, irregular heartbeat, extreme tiredness.
  • Signs of low sodium: headache, confusion, weakness, seizures.
  • Hearing problems: ringing in the ears (tinnitus), hearing loss.
  • Severe skin rash, blistering, or peeling.
  • Unusual bleeding or bruising.
  • Yellowing of skin or eyes (jaundice).
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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 allergic reaction you experienced, including any symptoms that occurred.
If you have difficulty urinating or are unable to pass urine.
If you are dehydrated or have electrolyte imbalances.
If you have a history of liver problems or low blood pressure.
* If you are taking any of the following medications: chloral hydrate, ethacrynic acid, or lithium.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Managing Diabetes
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Be aware of signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Report these symptoms to your doctor.

Dietary Considerations
If you follow a low-salt or salt-free diet, consult your doctor. Additionally, if you have high blood pressure and are taking this medication, discuss the use of 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.

Monitoring Your Condition
Regularly check your blood pressure as directed by your doctor. Also, have your blood work checked as recommended by your doctor and discuss the results with them.

Potential Side Effects
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, consult your doctor. You may require additional potassium supplements; discuss this with your doctor.

Interactions with Other Substances
Before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may cause drowsiness, consult your doctor.

Sun Sensitivity
This medication may increase your risk of sunburn. Take precautions when exposed to the sun, and inform your doctor if you experience excessive sunburn.

Other Potential Risks
Be aware of the possibility of gout attacks. If you have lupus, this medication may exacerbate your condition or trigger a flare-up. Report any new or worsening symptoms to your doctor promptly.

Hearing and Blood Cell Problems
Hearing problems, such as decreased hearing or hearing loss, have been reported with this medication. These issues may be temporary or permanent. If you experience ringing in the ears, changes in your hearing, or a feeling of fullness in your ears, contact your doctor immediately. Additionally, low blood cell counts have been associated with this medication, which can lead to bleeding problems, infections, or anemia. Seek medical attention if you have signs of infection, such as fever, chills, or sore throat, unexplained bruising or bleeding, or if you feel extremely tired or weak.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor will need to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis (excessive urination)
  • Severe dehydration
  • Electrolyte depletion (especially hypokalemia, hyponatremia, hypochloremia)
  • Hypotension (low blood pressure)
  • Cardiovascular collapse
  • Thrombosis and embolism (due to hemoconcentration)
  • Acute renal failure
  • Lethargy, confusion, coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment involves supportive care, fluid and electrolyte replacement, and monitoring of vital signs and renal function.

Drug Interactions

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Major Interactions

  • Aminoglycosides (e.g., gentamicin, tobramycin): Increased risk of ototoxicity.
  • Ethacrynic acid: Increased risk of ototoxicity.
  • Chloral hydrate: Transient flushing, sweating, blood pressure elevation, and tachycardia.
  • Lithium: Reduced renal clearance of lithium, leading to increased serum lithium levels and potential toxicity.
  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the diuretic and antihypertensive effects of furosemide and increase the risk of renal impairment.
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Moderate Interactions

  • ACE inhibitors/ARBs: Potentiation of antihypertensive effect, risk of severe hypotension and acute renal failure, especially with initial doses.
  • Digoxin: Increased risk of digoxin toxicity due to furosemide-induced hypokalemia.
  • Corticosteroids: Increased risk of hypokalemia.
  • Amphotericin B: Increased risk of hypokalemia.
  • Cisplatin: Increased risk of ototoxicity and nephrotoxicity.
  • Phenytoin: Decreased diuretic effect of furosemide.
  • Sucralfate: Decreased absorption of furosemide (separate administration by at least 2 hours).
  • Antidiabetic agents: May decrease the hypoglycemic effect of antidiabetic drugs.
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Minor Interactions

  • Probenecid: May reduce the diuretic effect of furosemide.
  • Salicylates (high dose): May compete for renal tubular secretion, increasing risk of salicylate toxicity.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Na, K, Cl, Mg, Ca)

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

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine)

Rationale: To assess baseline kidney function, as renal impairment can affect drug elimination and increase risk of adverse effects.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for hypotension.

Timing: Prior to initiation of therapy.

Fluid Status (Weight, Edema)

Rationale: To establish baseline and monitor therapeutic response and risk of dehydration.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Na, K, Cl, Mg, Ca)

Frequency: Daily initially, then weekly to monthly depending on patient stability and dose changes.

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)

Frequency: Weekly initially, then monthly or as clinically indicated.

Target: Within patient's baseline range.

Action Threshold: Significant increase in BUN/Creatinine (e.g., >25% above baseline or rapidly rising).

Blood Pressure

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

Target: Individualized, aiming for normotension without orthostatic hypotension.

Action Threshold: Symptomatic hypotension, orthostatic hypotension.

Fluid Status (Weight, Edema, Urine Output)

Frequency: Daily (weight), as clinically indicated (edema, urine output).

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

Action Threshold: Rapid weight loss (>2 lbs/day), signs of dehydration, persistent edema, oliguria.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized.

Action Threshold: Significant hyperglycemia.

Uric Acid

Frequency: Periodically, especially in patients with gout or predisposition.

Target: Within normal limits.

Action Threshold: Significant hyperuricemia, symptoms of gout.

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Symptom Monitoring

  • Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness, confusion)
  • Symptoms of electrolyte imbalance (muscle weakness, cramps, irregular heartbeat, nausea, vomiting, fatigue, confusion, seizures)
  • Orthostatic hypotension (dizziness upon standing)
  • Ototoxicity (hearing impairment, tinnitus, vertigo)
  • Gout flares (joint pain, swelling, redness)
  • Skin rash or photosensitivity

Special Patient Groups

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Pregnancy

Category C. Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It can cross the placental barrier. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though human data are limited. Generally avoided unless absolutely necessary.
Second Trimester: May be used if clearly indicated, with careful monitoring of maternal fluid and electrolyte status and fetal growth.
Third Trimester: May reduce placental perfusion and fetal growth. Can cause electrolyte disturbances in the newborn. Use with caution, especially near term.
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Lactation

L3 (Moderately safe). Furosemide is excreted in breast milk and may inhibit lactation. Use with caution. Monitor the infant for signs of dehydration, electrolyte imbalance, and weight loss.

Infant Risk: Low to moderate risk. Potential for dehydration, electrolyte imbalance (e.g., hypokalemia), and ototoxicity in the infant. May decrease milk supply.
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Pediatric Use

Use with caution. Dosing is weight-based. Neonates and infants may be more susceptible to adverse effects, particularly electrolyte imbalances and ototoxicity. Close monitoring of fluid and electrolytes is crucial.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive and electrolyte-depleting effects of furosemide. Start with lower doses and titrate slowly. Monitor fluid status, electrolytes, and renal function closely to prevent dehydration and acute kidney injury.

Clinical Information

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Clinical Pearls

  • Furosemide is a potent loop diuretic; careful monitoring of fluid and electrolytes is essential to prevent dehydration and severe electrolyte imbalances (especially hypokalemia).
  • The 80mg dose is considered high and is typically reserved for more severe edema or in patients with reduced renal function where higher doses are needed to achieve diuresis.
  • Administering the last dose of the day in the late afternoon (e.g., by 5-6 PM) can help prevent nocturia (nighttime urination) and sleep disturbance.
  • Patients on furosemide should be advised to report any signs of hearing changes (tinnitus, hearing loss) immediately, especially if also on other ototoxic drugs.
  • NSAIDs can significantly blunt the diuretic and antihypertensive effects of furosemide and increase the risk of renal dysfunction; concurrent use should be monitored closely.
  • In patients with ascites due to liver cirrhosis, furosemide should be used cautiously and often in combination with a potassium-sparing diuretic (e.g., spironolactone) to prevent hypokalemia and minimize the risk of hepatic encephalopathy.
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Alternative Therapies

  • Other Loop Diuretics: Bumetanide, Torsemide (often used when furosemide is ineffective or for different pharmacokinetic profiles).
  • Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone (for hypertension or mild edema, less potent than loop diuretics).
  • Potassium-Sparing Diuretics: Spironolactone, Eplerenone, Amiloride, Triamterene (used for potassium conservation or specific conditions like heart failure/cirrhosis).
  • Vasodilators (for hypertension): ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers.
  • Dialysis (for severe fluid overload refractory to diuretics).
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (80mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.