Furosemide 10mg/ml Oral Soln 120ml

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, Antihypertensive
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Pharmacologic Class
Loop Diuretic
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Pregnancy Category
Category C
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 can lower high blood pressure. It works by making your kidneys remove more fluid from your body.
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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.

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 color has changed, do not take the medication.
* When taking the liquid form of this medication, measure your dose accurately using the measuring device provided. 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. Avoid storing it in a bathroom or freezing it. 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'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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once or twice a day. Do not take a double dose.
  • Take in the morning to avoid frequent urination at night, unless otherwise directed by your doctor.
  • If taking twice a day, take the second dose in the late afternoon (e.g., 2 PM to 4 PM) to avoid nighttime urination.
  • Follow your doctor's recommendations for diet, especially regarding salt intake.
  • Your doctor may recommend potassium-rich foods or a potassium supplement to prevent low potassium levels.
  • Avoid excessive sun exposure as furosemide can make your skin more sensitive to the sun.
  • Avoid alcohol, as it can increase dizziness and dehydration.
  • Stand up slowly from a sitting or lying position to prevent dizziness or lightheadedness.

Dosing & Administration

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Adult Dosing

Standard Dose: Edema: 20-80 mg orally once daily or twice daily. Hypertension: 20-40 mg orally twice daily.
Dose Range: 20 - 600 mg

Condition-Specific Dosing:

edema: Initial: 20-80 mg orally as a single dose. May increase by 20-40 mg every 6-8 hours until desired effect. Max: 600 mg/day.
hypertension: Initial: 20-40 mg orally twice daily. Adjust dose based on response.
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Pediatric Dosing

Neonatal: Initial: 1-2 mg/kg/dose orally every 12-24 hours. Max: 6 mg/kg/day.
Infant: Initial: 1-2 mg/kg/dose orally every 12-24 hours. Max: 6 mg/kg/day.
Child: Initial: 1-2 mg/kg/dose orally once daily or twice daily. Max: 6 mg/kg/day or 40 mg/dose, whichever is less.
Adolescent: Initial: 1-2 mg/kg/dose orally once daily or twice daily. Max: 6 mg/kg/day or 40 mg/dose, whichever is less. For edema, adult dosing may apply (20-80 mg/day).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: Monitor closely; higher doses may be required for diuretic effect. Max dose may be limited.
Severe: Use with caution. Higher doses (e.g., 80-160 mg/day) may be needed for diuretic effect in patients with GFR < 30 mL/min/1.73m². Max dose 600 mg/day.
Dialysis: Furosemide is not significantly removed by dialysis. Dosing should be individualized based on residual renal function and fluid status. May be given post-dialysis.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution due to risk of electrolyte imbalance and hepatic encephalopathy. Monitor closely.
Severe: Use with extreme caution. May precipitate hepatic coma. Lower initial doses and careful titration are recommended. Monitor electrolytes and mental status closely.

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, leading to increased excretion of water, sodium, chloride, magnesium, and calcium. It also has a direct vasodilatory effect on renal vasculature, increasing renal blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: Oral bioavailability varies, typically 50-70% (range 10-100%).
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: 91-99% (primarily to albumin).
CnssPenetration: Limited

Elimination:

HalfLife: Oral: 1-2 hours (increased in renal/hepatic impairment).
Clearance: Renal clearance is approximately 60-70% of total clearance.
ExcretionRoute: Renal (primarily unchanged), some biliary/fecal.
Unchanged: 60-90% (renal excretion).
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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 dose 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 problem): severe stomach pain, severe back pain, or severe nausea or vomiting.
Severe dizziness or fainting.
Abnormal burning, numbness, or tingling sensations.
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 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, nausea, vomiting, or decreased appetite.
Stomach cramps.

Reporting Side Effects

This is not an exhaustive list of 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:

  • Severe dizziness or fainting
  • Signs of dehydration (extreme thirst, very dry mouth, decreased urination)
  • Muscle cramps or weakness
  • Irregular heartbeat
  • Unusual tiredness or weakness
  • Numbness or tingling in hands or feet
  • Sudden hearing loss or ringing in the ears (tinnitus)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe stomach pain, nausea, or vomiting
  • Rash or hives
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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. Describe the allergic reaction you experienced, including any symptoms.
If you have difficulty urinating or are unable to pass urine.
If you are dehydrated or have electrolyte imbalances.
Certain health conditions, including 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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.

Remember, do not start, stop, or change the dose of any medication without consulting your doctor first. This will help prevent potential interactions and ensure your safety while taking this medication.
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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, rise slowly from a sitting or lying position. Be cautious when climbing stairs.

Managing Diabetes
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Notify your doctor if you experience symptoms of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.

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 scheduled 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; 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 notify your doctor if you experience easy sunburning while taking this medication.

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

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 (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:

  • Severe dehydration
  • Electrolyte imbalances (especially very low potassium)
  • Profound hypotension (very low blood pressure)
  • Dizziness
  • Fainting
  • Confusion
  • Weakness
  • Kidney failure

What to Do:

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

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, blood pressure elevation, and tachycardia.
  • NSAIDs (e.g., ibuprofen, naproxen): May reduce diuretic and antihypertensive effects of furosemide; increased risk of renal toxicity.
  • Phenytoin: May reduce diuretic effect of furosemide.
  • Sucralfate: May reduce the natriuretic and antihypertensive effects of furosemide.
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Moderate Interactions

  • ACE inhibitors/ARBs: Increased risk of hypotension and renal dysfunction, 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.
  • Metformin: Increased metformin concentrations.
  • Cyclosporine: Increased risk of gouty arthritis due to hyperuricemia.
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Minor Interactions

  • Antidiabetic agents: May decrease the hypoglycemic effect of antidiabetic agents.
  • Muscle relaxants (non-depolarizing): May potentiate 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, 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 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 to weekly initially, then monthly or as clinically indicated.

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: Stable or improving.

Action Threshold: Significant increase in BUN/creatinine (e.g., >25% increase from baseline), signs of acute kidney injury.

Blood Pressure

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

Target: Individualized, within target range for condition.

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

Fluid Status (Daily Weight, Edema Assessment, I&O)

Frequency: Daily (especially in acute settings) or as clinically indicated.

Target: Gradual weight loss (0.5-1 kg/day), reduction in edema.

Action Threshold: Excessive weight loss (>1-2 kg/day), signs of dehydration (e.g., orthostasis, dry mucous membranes), persistent edema despite adequate dosing.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized.

Action Threshold: Significant hyperglycemia.

Uric Acid

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

Target: Within normal limits.

Action Threshold: Significant hyperuricemia, symptoms of gout.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Muscle cramps or weakness
  • Nausea
  • Vomiting
  • Excessive thirst
  • Dry mouth
  • Increased urination
  • Fatigue
  • Confusion
  • Irregular heartbeat
  • Hearing changes (tinnitus, hearing loss)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Furosemide can cross the placenta. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some adverse effects.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though human data are limited.
Second Trimester: Risk of electrolyte imbalance and volume depletion in the mother, which could affect placental perfusion.
Third Trimester: Risk of electrolyte imbalance and volume depletion in the mother. May inhibit lactation.
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Lactation

L3 (Moderately Safe). Furosemide is excreted into breast milk and can inhibit lactation by suppressing milk production. Use with caution. Monitor infant for dehydration, electrolyte imbalance, and weight loss.

Infant Risk: Low to moderate risk. Potential for dehydration, electrolyte disturbances, and ototoxicity in the infant. May decrease milk supply.
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Pediatric Use

Dosing is weight-based and individualized. Neonates and infants may be more susceptible to electrolyte imbalances and ototoxicity. Careful monitoring of fluid and electrolyte status is crucial. Oral solution is often preferred for ease of administration.

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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 carefully. Monitor renal function, electrolytes, and blood pressure closely. Increased risk of falls due to orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Furosemide is a potent diuretic; careful monitoring of fluid and electrolyte status is essential to prevent dehydration and severe electrolyte imbalances (especially hypokalemia).
  • Administer oral doses in the morning to avoid nocturia (nighttime urination). If a second dose is needed, give it in the late afternoon.
  • Patients should be advised to report symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat) immediately.
  • Ototoxicity (hearing loss, tinnitus) is a rare but serious side effect, especially with rapid IV administration, high doses, or in patients with renal impairment or concurrent use of other ototoxic drugs (e.g., aminoglycosides).
  • Furosemide can cause hyperglycemia and hyperuricemia; monitor blood glucose and uric acid levels, especially in diabetic or gout-prone patients.
  • Oral solution is useful for patients who cannot swallow tablets or for precise pediatric dosing.
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Alternative Therapies

  • Other loop diuretics (e.g., torsemide, bumetanide)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone) for hypertension or mild edema
  • Potassium-sparing diuretics (e.g., spironolactone, amiloride) often used in combination with loop diuretics to counteract potassium loss
  • Aldosterone antagonists (e.g., spironolactone, eplerenone) for heart failure with reduced ejection fraction or resistant hypertension
  • Vasodilators (e.g., nitrates) for acute heart failure management
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 120ml bottle of 10mg/ml oral solution
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 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 information about the medication taken, the amount, and the time it happened.