Furosemide 10mg/ml Inj 2ml

Manufacturer HERITAGE PHARMACEUTICALS Active Ingredient Furosemide Injection(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.
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Drug Class
Loop Diuretic
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Pharmacologic Class
Sulfonamide-derived Loop Diuretic
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Pregnancy Category
Category 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 can help reduce swelling (edema) and lower blood pressure. It works by making your kidneys remove more fluid through urine.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered via injection into a muscle or vein.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Follow your doctor's instructions regarding fluid intake and dietary salt restrictions.
  • Weigh yourself daily at the same time, wearing similar clothing, and report significant changes to your doctor.
  • Be aware of symptoms of dehydration or electrolyte imbalance (e.g., dizziness, muscle cramps, excessive thirst).
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Limit alcohol intake as it can increase the risk of dizziness and dehydration.
  • Discuss any over-the-counter medications or supplements with your doctor before taking them.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 to 40 mg IV/IM once or twice daily
Dose Range: 20 - 600 mg

Condition-Specific Dosing:

Edema (acute pulmonary edema): 40 mg IV over 1-2 minutes; if response is not satisfactory within 1 hour, dose may be increased to 80 mg IV.
Edema (congestive heart failure, renal disease, hepatic cirrhosis): 20 to 40 mg IV/IM once or twice daily. May be increased by 20 mg increments every 6-8 hours until desired diuretic effect is obtained. Max 600 mg/day.
Hypertension (adjunct): Not typically used as monotherapy for hypertension; usually oral formulation. For hypertensive crisis with pulmonary edema, IV doses as for acute pulmonary edema.
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Pediatric Dosing

Neonatal: 1 mg/kg IV/IM once or twice daily; may increase by 1 mg/kg increments every 12-24 hours. Max 6 mg/kg/day.
Infant: 1 mg/kg IV/IM once or twice daily; may increase by 1 mg/kg increments every 12-24 hours. Max 6 mg/kg/day.
Child: 1 mg/kg IV/IM once or twice daily; may increase by 1 mg/kg increments every 12-24 hours. Max 6 mg/kg/day.
Adolescent: 1 mg/kg IV/IM once or twice daily; may increase by 1 mg/kg increments every 12-24 hours. Max 6 mg/kg/day (or adult dose if higher).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: Initial dose may be reduced; monitor closely. Higher doses may be required for adequate diuresis in advanced renal failure.
Severe: Higher doses (e.g., 80-160 mg IV) may be required for adequate diuresis. Max 600 mg/day. Monitor for ototoxicity.
Dialysis: Furosemide is not significantly removed by hemodialysis. Dosing should be individualized based on residual renal function and fluid status. May be given after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor closely for electrolyte imbalances and hepatic encephalopathy.
Moderate: Use with caution. Reduced doses may be necessary. Monitor for electrolyte imbalances and hepatic encephalopathy.
Severe: Use with extreme caution. Reduced doses may be necessary. Increased risk of electrolyte imbalances and hepatic encephalopathy. Avoid in hepatic coma or pre-coma.

Pharmacology

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Mechanism of Action

Furosemide inhibits the Na+-K+-2Cl- cotransporter (NKCC2) in the thick ascending limb of the loop of Henle, leading to increased excretion of sodium, chloride, and water. It also causes vasodilation, which contributes to its antihypertensive effect.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Immediate (IV)
FoodEffect: Not applicable for IV administration

Distribution:

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

Elimination:

HalfLife: 0.5-2 hours (normal renal function); prolonged in renal impairment
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily unchanged drug), some biliary/fecal
Unchanged: 60-90% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Within 5 minutes (IV)
PeakEffect: Within 20-60 minutes (IV)
DurationOfAction: Approximately 2 hours (IV)

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 dosing must be individualized.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine production
+ 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
+ Changes in urine production
+ Blood in the urine
+ Sudden weight gain
Signs of pancreatitis (pancreas problems), 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 sensations
+ Blurred vision
+ Restlessness
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which may also affect internal organs. These can be life-threatening. Seek medical help immediately 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. However, many people do not experience any side effects or only have 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 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
  • Extreme thirst or dry mouth
  • Muscle weakness or cramps
  • Irregular heartbeat
  • Nausea or vomiting that doesn't stop
  • Decreased urination
  • Ringing in the ears or hearing loss
  • Unusual tiredness or confusion
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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 the symptoms that occurred.
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 first consulting your doctor to ensure your safety.
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. 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
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 consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may slow your reactions, 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, may occur with this medication. In some cases, these problems may be temporary, while in others, 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, this medication may cause low blood cell counts, which can lead to bleeding problems, infections, or anemia. If you experience signs of infection (fever, chills, sore throat), unexplained bruising or bleeding, or feel extremely tired or weak, contact your doctor promptly.

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
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Profound diuresis
  • Severe dehydration
  • Electrolyte depletion (hypokalemia, hyponatremia, hypochloremia)
  • Hypotension
  • Cardiovascular collapse
  • Thrombosis and embolism (due to hemoconcentration)
  • Acute renal failure
  • Anuria

What to Do:

Seek immediate medical attention. Management is primarily supportive, including fluid and electrolyte replacement. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Major Interactions

  • Aminoglycosides (e.g., gentamicin, amikacin): Increased risk of ototoxicity and nephrotoxicity.
  • 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.
  • Cisplatin: Increased risk of ototoxicity and nephrotoxicity.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, indomethacin): May reduce diuretic and antihypertensive effects of furosemide; increased risk of renal impairment.
  • ACE inhibitors/ARBs: May cause profound hypotension and/or acute renal failure, especially with initial doses.
  • Digoxin: Increased risk of digoxin toxicity due to hypokalemia.
  • Corticosteroids: Increased risk of hypokalemia.
  • Non-depolarizing muscle relaxants: May enhance or prolong neuromuscular blockade.
  • Phenytoin: May reduce diuretic effect of furosemide.
  • Sucralfate: May reduce absorption of furosemide (if given orally, but relevant for IV if patient is on both).
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Minor Interactions

  • Antidiabetic agents: May decrease hypoglycemic effect.
  • Probenecid: May decrease renal clearance of furosemide.

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, 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, Urine Output)

Rationale: To assess baseline fluid overload and guide initial therapy.

Timing: Prior to initiation of therapy

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Routine Monitoring

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

Frequency: Daily initially, then 2-3 times weekly, then weekly to monthly depending on stability and clinical status.

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

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

Renal Function (BUN, Serum Creatinine)

Frequency: Daily initially, then 2-3 times weekly, then weekly to monthly depending on stability and clinical status.

Target: Stable or improving from baseline

Action Threshold: Significant increase in BUN/Creatinine (e.g., >25% increase from baseline or absolute increase indicating acute kidney injury).

Blood Pressure

Frequency: Daily or multiple times daily initially, then as clinically indicated.

Target: Individualized, avoiding symptomatic hypotension.

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

Fluid Status (Weight, Edema, Urine Output, Intake/Output)

Frequency: Daily (weight, I/O), or as clinically indicated.

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

Action Threshold: Excessive weight loss (>1-2 kg/day), signs of dehydration, oliguria, or persistent fluid overload.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized

Action Threshold: Significant hyperglycemia.

Serum Uric Acid

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

Target: Within normal limits

Action Threshold: Significant hyperuricemia, symptomatic gout.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Muscle cramps or weakness
  • Excessive thirst or dry mouth
  • Nausea or vomiting
  • Unusual tiredness or weakness
  • Irregular heartbeat
  • Hearing impairment or ringing in the ears (tinnitus)
  • Signs of dehydration (decreased skin turgor, sunken eyes)
  • Confusion or lethargy (signs of severe electrolyte imbalance or hepatic encephalopathy)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Furosemide has been shown to cause maternal and fetal deaths, abortions, and resorptions in animals at doses several times the maximum recommended human dose. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, especially with high doses or prolonged use.
Second Trimester: Potential for fetal harm, especially with high doses or prolonged use.
Third Trimester: May cause electrolyte disturbances in the mother and fetus, and potentially inhibit labor. Risk of neonatal jaundice, thrombocytopenia, and other adverse reactions.
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Lactation

Furosemide is excreted in breast milk. It 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: Potential for infant adverse effects such as dehydration, electrolyte imbalance, and ototoxicity. Monitor infant for signs of dehydration or electrolyte disturbances.
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Pediatric Use

Use with caution. Neonates and infants may have prolonged half-life due to immature renal function. Higher risk of ototoxicity, especially in premature infants or those with impaired renal function. 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 carefully. Increased risk of falls due to orthostatic hypotension. Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • Administer IV furosemide slowly (over 1-2 minutes for doses up to 40 mg; larger doses over 10-20 minutes) to minimize the risk of ototoxicity.
  • Rapid IV administration can lead to transient hearing impairment or permanent deafness, especially in patients with renal impairment or those receiving other ototoxic drugs.
  • Furosemide is a sulfonamide derivative; caution in patients with sulfonamide allergy, though cross-reactivity is rare.
  • Monitor for signs of hypokalemia (e.g., muscle cramps, weakness, cardiac arrhythmias) and consider potassium supplementation or potassium-sparing diuretics if needed.
  • Patients with hepatic cirrhosis and ascites should be monitored closely for electrolyte imbalances and hepatic encephalopathy; consider combination with a potassium-sparing diuretic (e.g., spironolactone).
  • In patients with severe renal impairment, higher doses may be required, but the risk of ototoxicity increases.
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Alternative Therapies

  • Other loop diuretics (e.g., torsemide, bumetanide)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone) for less potent diuresis or hypertension
  • Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) often used in combination with loop diuretics to mitigate potassium loss
  • Vasodilators (e.g., nitrates) for acute pulmonary edema
  • Beta-blockers, ACE inhibitors, ARBs, calcium channel blockers (for hypertension or heart failure management)
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Cost & Coverage

Average Cost: Varies widely, typically low cost for generic per 2ml vial (10mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.