Furosemide 10mg/ml Oral Soln 60ml

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
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 can lower high blood pressure. It works by making your kidneys remove more water and salt from your blood.
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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. 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.
- Check the medication for any color changes before taking it. If the product has changed color, do not take it.
- When measuring liquid doses, use the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:
- Store it at room temperature, away from light.
- Keep it in a dry place, avoiding storage in bathrooms.
- Do not freeze the medication.
- Keep all medications in a 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 continue with your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
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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 help prevent nighttime urination.
  • Do not stop taking this medication without talking to your doctor.
  • Monitor your weight daily and report any sudden changes (e.g., gain or loss of more than 2-3 pounds in a day) to your doctor.
  • Avoid standing up too quickly from a sitting or lying position to prevent dizziness or lightheadedness.
  • Discuss dietary salt intake with your doctor. You may be advised to limit salt.
  • Report any signs of dehydration or electrolyte imbalance such as excessive thirst, dry mouth, muscle cramps, weakness, or unusual tiredness.
  • Avoid alcohol, as it can increase dizziness and lower blood pressure.
  • Limit sun exposure and use sunscreen, as furosemide can increase sensitivity to sunlight.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 to 80 mg orally once daily or twice daily
Dose Range: 20 - 600 mg

Condition-Specific Dosing:

edema: Initial 20 to 80 mg orally once daily. May be increased by 20 to 40 mg every 6 to 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: Not established for routine use; use with extreme caution and close monitoring if necessary (e.g., 1-2 mg/kg/dose, not exceeding 6 mg/kg/day).
Infant: Initial 2 mg/kg orally once daily. May be increased by 1 to 2 mg/kg every 6 to 12 hours. Max 6 mg/kg/day.
Child: Initial 2 mg/kg orally once daily. May be increased by 1 to 2 mg/kg every 6 to 12 hours. Max 6 mg/kg/day.
Adolescent: Initial 2 mg/kg orally once daily. May be increased by 1 to 2 mg/kg every 6 to 12 hours. Max 6 mg/kg/day (or adult dose if weight appropriate).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor response and electrolytes.
Moderate: Monitor closely, may require higher doses to achieve effect, but increased risk of adverse effects. Max 600 mg/day.
Severe: Monitor closely, may require higher doses (e.g., up to 600 mg/day) but increased risk of ototoxicity and electrolyte imbalance. Use with caution.
Dialysis: Furosemide is not significantly dialyzable. Dosing should be individualized based on residual renal function and fluid status. May require higher doses in anuric patients.

Hepatic Impairment:

Mild: No specific adjustment, monitor for electrolyte imbalance.
Moderate: Use with caution due to increased risk of electrolyte imbalance and hepatic encephalopathy. Lower initial doses may be considered.
Severe: Contraindicated in hepatic coma or states of severe electrolyte depletion until condition is improved. Use with extreme caution due to risk of hepatic encephalopathy.

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: 40-70% (highly variable)
Tmax: 1-2 hours
FoodEffect: Food may decrease the rate and extent of absorption, but typically not clinically significant for total absorption.

Distribution:

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

Elimination:

HalfLife: 0.5-2 hours (normal renal function); prolonged in renal impairment (up to 9 hours)
Clearance: Not available
ExcretionRoute: Renal (60-80%), 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 the dose must be adjusted to the individual patient's needs.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other severe symptoms, including:
+ Very bad dizziness or passing out
+ Burning, numbness, or tingling feeling that is not normal
+ Blurred vision
+ Restlessness
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the 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
Upset stomach
Vomiting
Decreased appetite
Stomach cramps

This is not a complete 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
  • Muscle cramps or weakness
  • Irregular or fast heartbeat
  • Unusual tiredness or weakness
  • Nausea or vomiting that doesn't stop
  • Dry mouth or extreme thirst
  • Decreased urination or no urination
  • Ringing in the ears or hearing loss
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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.
* If you are currently taking any of the following medications: chloral hydrate, ethacrynic acid, or lithium.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Before starting, stopping, or modifying the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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. 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 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 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 Protection
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 possibility of gout attacks. If you have lupus, this medication may exacerbate your condition or trigger a flare-up; promptly notify your doctor if you experience new or worsening symptoms.

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 experience symptoms such as fever, chills, sore throat, unexplained bruising or bleeding, or extreme fatigue and weakness.

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 or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive, focusing on fluid and electrolyte replacement, and correction of hypotension.

Drug Interactions

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Contraindicated Interactions

  • Ethacrynic acid (increased risk of ototoxicity)
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Major Interactions

  • Aminoglycosides (increased risk of ototoxicity and nephrotoxicity)
  • Cisplatin (increased risk of ototoxicity)
  • Lithium (reduced renal clearance of lithium, leading to toxicity)
  • NSAIDs (may reduce diuretic and antihypertensive effects of furosemide, increased risk of renal dysfunction)
  • Digoxin (increased risk of digoxin toxicity due to hypokalemia)
  • Phenytoin (may reduce diuretic effect of furosemide)
  • Sucralfate (may reduce absorption of furosemide)
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Moderate Interactions

  • Antihypertensives (additive hypotensive effects)
  • Corticosteroids (increased risk of hypokalemia)
  • Amphotericin B (increased risk of hypokalemia)
  • Muscle relaxants, non-depolarizing (potentiated effect)
  • Probenecid (may reduce renal clearance of furosemide)
  • Salicylates (may compete for renal excretion, especially in high doses)
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Minor Interactions

  • Not available

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 its efficacy/safety can be affected by renal impairment.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for excessive hypotension.

Timing: Prior to initiation of therapy.

Fluid Status (Weight, Edema)

Rationale: To establish baseline and monitor therapeutic response and potential for 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 periodically (e.g., monthly or as clinically indicated) once stable.

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. Requires intervention (e.g., supplementation, dose adjustment, discontinuation).

Renal Function (BUN, Serum Creatinine)

Frequency: Weekly initially, then periodically (e.g., every 1-3 months or as clinically indicated).

Target: Within patient's baseline or normal limits.

Action Threshold: Significant increase in BUN/Creatinine (e.g., >25% above baseline or significant rise above normal range). Requires investigation for acute kidney injury, dose adjustment, or discontinuation.

Blood Pressure

Frequency: Daily initially, then regularly (e.g., daily at home, at each clinic visit).

Target: Individualized, aiming for therapeutic effect without symptomatic hypotension.

Action Threshold: Symptomatic hypotension (dizziness, syncope), or systolic BP < 90 mmHg. Requires dose reduction or discontinuation.

Fluid Status (Weight, Edema, Urine Output)

Frequency: Daily (weight), daily (urine output), at each clinic visit (edema).

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

Action Threshold: Rapid weight loss (>1-2 kg/day), signs of dehydration (dry mucous membranes, orthostasis), or persistent/worsening edema. Requires dose adjustment or fluid management.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized.

Action Threshold: Significant hyperglycemia. May require adjustment of antidiabetic medications.

Uric Acid

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

Target: Within normal limits.

Action Threshold: Significant hyperuricemia or symptoms of gout. May require allopurinol or other management.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Muscle cramps or weakness
  • Excessive thirst
  • Dry mouth
  • Nausea
  • Vomiting
  • Fatigue
  • Confusion
  • Irregular heartbeat
  • Hearing changes (tinnitus, hearing loss)
  • Skin rash or itching
  • Gout flares

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.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for adverse effects on fetal development cannot be ruled out.
Second Trimester: May be used if clearly needed, but close monitoring of maternal fluid and electrolyte status is crucial.
Third Trimester: Use with caution, as it may cause electrolyte disturbances in the neonate and potentially inhibit lactation.
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Lactation

Furosemide is excreted in breast milk and may suppress 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 dehydration, electrolyte imbalance, and ototoxicity in the infant. May decrease milk supply.
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Pediatric Use

Use with caution, especially in neonates and infants, due to increased risk of electrolyte disturbances, dehydration, and ototoxicity. Close monitoring of fluid and electrolyte balance is essential. Dosing is weight-based.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive and electrolyte-depleting effects of furosemide. Lower initial doses and careful titration are recommended. Increased risk of falls due to orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Furosemide is a potent diuretic; monitor fluid and electrolyte status (especially potassium) very closely.
  • Administer oral doses in the morning and early afternoon to avoid nocturia.
  • Rapid IV administration or high doses can cause transient or permanent ototoxicity, especially in patients with renal impairment or when co-administered with other ototoxic drugs.
  • Patients should be advised to report any signs of hearing impairment or tinnitus immediately.
  • May cause photosensitivity; advise patients to use sun protection.
  • Can exacerbate gout due to hyperuricemia.
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Alternative Therapies

  • Other loop diuretics (e.g., bumetanide, torsemide)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone) for less potent diuresis or hypertension
  • Potassium-sparing diuretics (e.g., spironolactone, amiloride) often used in combination to mitigate potassium loss
  • Aldosterone antagonists (e.g., spironolactone, eplerenone) for heart failure or resistant hypertension
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Cost & Coverage

Average Cost: $15 - $50 per 60ml of 10mg/ml oral solution
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) for most insurance plans
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.