Furosemide 8mg/ml Solution

Manufacturer ROXANE Active Ingredient Furosemide Oral Solution(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
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 as urine.
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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.

Important Administration Guidelines

Do not take sucralfate within 2 hours before or after taking this medication.
Check the product for any color changes before taking it. If the product has changed color, do not take it.
* When taking the liquid form of this medication, measure your dose accurately using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets.

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 exactly as prescribed, usually once or twice a day. Taking it in the morning and early afternoon can prevent 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.
  • Be aware of signs of dehydration (e.g., extreme thirst, dry mouth, decreased urination, dizziness) and electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
  • Avoid excessive alcohol intake, as it can increase dizziness and dehydration.
  • Discuss dietary salt intake with your doctor. You may be advised to limit salt.
  • Stand up slowly from a sitting or lying position to avoid dizziness due to a sudden drop in blood pressure.
  • Protect yourself from the sun, as furosemide can make your skin more sensitive to sunlight.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 to 80 mg orally as a single dose, or 20 to 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. Max: 600 mg/day.
hypertension: Initial: 40 mg orally twice daily. Adjust dose based on response.
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Pediatric Dosing

Neonatal: Initial: 1-2 mg/kg/dose orally, once or twice daily. Max: 6 mg/kg/day.
Infant: Initial: 1-2 mg/kg/dose orally, once or twice daily. Max: 6 mg/kg/day.
Child: Initial: 1-2 mg/kg/dose orally, once or twice daily. Max: 6 mg/kg/day.
Adolescent: Initial: 1-2 mg/kg/dose orally, once or twice daily. Max: 6 mg/kg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor response and electrolytes.
Moderate: Monitor closely, may require higher doses or more frequent administration. Max dose may be limited.
Severe: Monitor closely, may require higher doses or more frequent administration. Max dose may be limited. Avoid if anuric.
Dialysis: Furosemide is not significantly removed by dialysis. Dosing should be based on residual renal function and fluid status. May be given after dialysis.

Hepatic Impairment:

Mild: No specific adjustment, monitor for electrolyte imbalance and hepatic encephalopathy.
Moderate: Use with caution, monitor for electrolyte imbalance and hepatic encephalopathy. Reduced doses may be necessary.
Severe: Use with extreme caution, monitor for electrolyte imbalance and hepatic encephalopathy. Reduced doses are often necessary to avoid precipitating hepatic coma.

Pharmacology

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Mechanism of Action

Furosemide is a loop diuretic that inhibits the Na+-K+-2Cl- cotransporter (NKCC2) 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 vasculature, increasing renal blood flow.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: 91-99% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 0.5-2 hours (prolonged in renal impairment)
Clearance: Not available
ExcretionRoute: Renal (primarily unchanged drug), some biliary/fecal.
Unchanged: 60-80% (renal)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral)
PeakEffect: 1-2 hours (oral)
DurationOfAction: 6-8 hours (oral)

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 dose and dose schedule must be adjusted to the individual 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe nausea or vomiting.
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of kidney problems: difficulty urinating, changes in urine output, blood in the urine, or sudden weight gain.
Signs of pancreatitis (pancreas problems): severe stomach pain, severe back pain, or severe nausea or vomiting.
Severe dizziness or fainting.
Abnormal sensations such as burning, numbness, or tingling.
Blurred vision.
Restlessness.

Severe Skin Reactions

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 also affect other organs. Seek immediate medical help 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 may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dizziness or headache.
Constipation, diarrhea, nausea, vomiting, or decreased appetite.
Stomach cramps.

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 or fainting
  • Muscle cramps or weakness
  • Irregular or fast heartbeat
  • Unusual tiredness or weakness
  • Nausea or vomiting that doesn't stop
  • Extreme thirst or dry mouth
  • Decreased urination or no urination
  • Ringing in the ears or hearing loss
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe skin rash or blistering
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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:

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 are dehydrated or have electrolyte imbalances.
If you have a history of liver problems or low blood pressure.

Additionally, tell your doctor if you are taking any of the following medications:
Chloral hydrate
Ethacrynic acid
* Lithium

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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, unusual 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 with 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.

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
Be aware that this medication may cause high cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, consult your doctor. You may also require additional potassium; 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 easy sunburning while taking this medication.

Other Potential Risks
Be aware of the potential for gout attacks. If you have lupus, this medication may reactivate or worsen your condition; report any new or worsening symptoms to your doctor immediately.

Hearing and Blood Cell Problems
Hearing problems, such as decreased hearing or hearing loss, may occur with this medication. Sometimes these issues may resolve, but in other cases, they may be 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 may occur, which can lead to bleeding problems, infections, or anemia. Seek medical attention if you experience signs of infection (fever, chills, sore throat), unexplained bruising or bleeding, or 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 Poison Control at 1-800-222-1222. Treatment is supportive, focusing on fluid and electrolyte replacement, and blood pressure support.

Drug Interactions

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Major Interactions

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

  • ACE inhibitors/ARBs: Increased risk of hypotension and renal dysfunction, especially with initial doses.
  • Digoxin: Hypokalemia induced by furosemide can potentiate digoxin toxicity.
  • Corticosteroids: Increased risk of hypokalemia.
  • Amphotericin B: Increased risk of hypokalemia.
  • Cisplatin: Increased risk of ototoxicity and nephrotoxicity.
  • Phenytoin: May reduce the diuretic effect of furosemide.
  • Sucralfate: May reduce the absorption of furosemide; administer 2 hours apart.
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Minor Interactions

  • Antidiabetic agents: Furosemide may cause hyperglycemia, requiring adjustment of antidiabetic medication.
  • Muscle relaxants (nondepolarizing): May enhance the effect of muscle relaxants.

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 furosemide is primarily renally eliminated and can affect renal perfusion.

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 assess baseline hydration status and monitor therapeutic response.

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 stability and dose changes.

Target: Within normal limits (e.g., K: 3.5-5.0 mEq/L, Na: 135-145 mEq/L)

Action Threshold: Potassium < 3.0 mEq/L (consider supplementation), Sodium < 130 mEq/L (consider fluid restriction/dose adjustment), significant changes from baseline.

Renal Function (BUN, Serum Creatinine)

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

Target: Stable or improving from baseline.

Action Threshold: Significant increase in BUN/creatinine (e.g., >25% increase or absolute increase >0.5 mg/dL) from baseline.

Blood Pressure

Frequency: Daily initially, then regularly at home or clinic visits.

Target: Individualized, typically <130/80 mmHg for hypertension.

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

Fluid Status (Daily Weight, Edema, Urine Output)

Frequency: Daily (weight, urine output), regular assessment of edema.

Target: Weight loss of 0.5-1 kg/day (for edema reduction), resolution of edema.

Action Threshold: Excessive weight loss (>1-2 kg/day), signs of dehydration, 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 gout history.

Target: Within normal limits.

Action Threshold: Significant hyperuricemia or symptoms of gout.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Muscle cramps or weakness
  • Nausea
  • Vomiting
  • Excessive thirst
  • Dry mouth
  • Unusual tiredness or weakness
  • Irregular heartbeat
  • Hearing changes (tinnitus, hearing loss)
  • Signs of dehydration (decreased urination, dry skin)
  • Confusion
  • Lethargy

Special Patient Groups

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Pregnancy

Furosemide is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It can cause fetal or neonatal jaundice, thrombocytopenia, and other adverse reactions seen in adults. In animal studies, it has shown some adverse effects at high doses.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless absolutely necessary due to potential for electrolyte imbalance and effects on fetal development.
Second Trimester: Use with caution; monitor maternal fluid and electrolyte status closely. May affect placental perfusion.
Third Trimester: Use with caution; may cause fetal or neonatal jaundice, thrombocytopenia, or other adverse reactions. Can affect maternal fluid balance and blood pressure.
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Lactation

Furosemide is excreted in breast milk and may inhibit lactation. 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: Low to moderate risk. Potential for infant dehydration, electrolyte imbalance, and ototoxicity. May decrease milk supply.
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive and electrolyte-depleting effects of furosemide. Initial doses should be lower, and titration should be gradual. Close monitoring of renal function, electrolytes, and hydration status is essential.

Clinical Information

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Clinical Pearls

  • Furosemide oral solution (8mg/ml) is particularly useful for patients who have difficulty swallowing tablets or require precise dose adjustments, especially in pediatric or geriatric populations.
  • Administer furosemide in the morning to avoid nocturia (nighttime urination). If a second dose is needed, give it in the early afternoon.
  • Always monitor electrolytes (especially potassium) closely, as hypokalemia is a common and potentially serious side effect. Potassium supplementation or potassium-sparing diuretics may be needed.
  • Educate patients on the signs of dehydration and electrolyte imbalance, and advise them to report these symptoms immediately.
  • Caution patients about orthostatic hypotension (dizziness upon standing) and advise them to rise slowly.
  • Furosemide can cause ototoxicity, especially with rapid IV administration, high doses, or in patients with renal impairment or concurrent use of other ototoxic drugs (e.g., aminoglycosides).
  • NSAIDs can reduce the diuretic and antihypertensive effects of furosemide and increase the risk of renal dysfunction; concurrent use should be monitored carefully.
  • In patients with severe heart failure, continuous infusion of furosemide may be more effective and safer than intermittent bolus dosing.
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Alternative Therapies

  • Other loop diuretics (e.g., torsemide, bumetanide, ethacrynic acid)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone) for hypertension or mild edema
  • Potassium-sparing diuretics (e.g., spironolactone, eplerenone, amiloride, triamterene) often used in combination to counteract potassium loss or for specific indications like heart failure.
  • Vasodilators (e.g., nitrates, hydralazine) for heart failure or hypertension.
  • ACE inhibitors/ARBs (for heart failure, hypertension, renal protection).
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Cost & Coverage

Average Cost: Price varies widely by pharmacy and concentration (e.g., $10-$50) per 120 ml of 8mg/ml solution
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 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 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 details about the medication taken, the amount, and the time it happened.