Furosemide 10mg/ml Inj, 10ml

Manufacturer ATHENEX PHARMACEUTICAL 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
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 strong 'water pill' (diuretic) that helps your body get rid of extra salt and water through your urine. This helps to reduce swelling (edema) and lower blood pressure. It's often used for conditions like heart failure, kidney disease, or liver disease.
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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. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via injection into a muscle or vein.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

If you miss a dose, contact your doctor immediately 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 restriction.
  • Report any signs of dehydration (e.g., excessive thirst, dry mouth, dizziness) or electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
  • Avoid sudden changes in position to prevent dizziness or lightheadedness.
  • If you have diabetes, monitor your blood sugar closely as furosemide can affect it.
  • Avoid alcohol as it can increase the risk of dizziness and low blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: Edema: 20 to 40 mg IV/IM once, may repeat in 1-2 hours with 20 mg increments until desired effect. Acute Pulmonary Edema: 40 mg IV over 1-2 minutes, if not satisfactory in 1 hour, 80 mg IV.
Dose Range: 20 - 600 mg

Condition-Specific Dosing:

acutePulmonaryEdema: 40 mg IV initially, then 80 mg IV if needed after 1 hour.
chronicRenalFailure: Initial 80 mg IV, may increase by 80 mg every 6-8 hours up to 1600 mg/day.
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Pediatric Dosing

Neonatal: 0.5 to 1 mg/kg IV/IM every 12-24 hours. Max 2 mg/kg/dose.
Infant: 1 mg/kg IV/IM once, then 1 mg/kg every 6-12 hours. Max 6 mg/kg/dose.
Child: 1 mg/kg IV/IM once, then 1 mg/kg every 6-12 hours. Max 6 mg/kg/dose.
Adolescent: 1 mg/kg IV/IM once, then 1 mg/kg every 6-12 hours. Max 6 mg/kg/dose (or adult dose if higher).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor closely.
Moderate: No specific adjustment, monitor closely. Higher doses may be required for efficacy.
Severe: Higher doses may be required for efficacy (e.g., 80-160 mg IV). Max dose up to 1600 mg/day in severe renal failure.
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 closely.
Moderate: Use with caution. Reduced doses or extended intervals may be necessary due to increased risk of electrolyte imbalance and hepatic encephalopathy.
Severe: Use with extreme caution. Reduced doses and close monitoring are essential due to increased risk of hepatic encephalopathy and hepatorenal syndrome.

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 and systemic vasculature.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: 91-99%
CnssPenetration: Limited

Elimination:

HalfLife: 0.5-2 hours (increased in renal impairment)
Clearance: Approximately 60-100 mL/min
ExcretionRoute: Renal (primarily unchanged), some biliary/fecal
Unchanged: 60-90% (renal)
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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 the dose must be adjusted to the patient's needs.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction: 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, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellowing of the skin and eyes.
Signs of kidney problems: inability to urinate, 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 and 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 internal organs. Seek immediate medical help if you experience:

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 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 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 (very dry mouth, extreme thirst, decreased urination)
  • Muscle cramps or weakness
  • Irregular or fast heartbeat
  • Unusual tiredness or weakness
  • Numbness or tingling
  • Hearing problems (ringing in ears, hearing loss)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Severe stomach pain
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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 reactions 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 determine if it is safe to take this medication with your existing treatments and health conditions.

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

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

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

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.

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

Be aware that this medication may cause increased cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, consult your doctor. You may require additional potassium supplements; discuss this with your doctor.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may cause drowsiness, consult your doctor.

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

Monitor yourself for gout attacks. If you have lupus, this medication may reactivate or worsen the condition. Immediately report any new or worsening symptoms to your doctor.

Be aware that this medication may cause hearing problems, such as decreased hearing or hearing loss, which 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 promptly.

Low blood cell counts may occur with this medication, which can lead to bleeding problems, infections, or anemia. If you experience signs of infection, such as fever, chills, or sore throat, unexplained bruising or bleeding, or feel extremely tired or weak, contact your doctor immediately.

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

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 (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:

Call 1-800-222-1222 (Poison Control). Treatment is supportive, focusing on fluid and electrolyte replacement. Induce emesis or gastric lavage if recent oral ingestion. Monitor vital signs, fluid balance, and electrolytes closely.

Drug Interactions

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Major Interactions

  • Aminoglycosides (increased ototoxicity)
  • Ethacrynic acid (increased ototoxicity)
  • Lithium (increased lithium toxicity due to decreased renal clearance)
  • Chloral hydrate (flushing, sweating, blood pressure changes)
  • Cisplatin (increased ototoxicity and nephrotoxicity)
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Moderate Interactions

  • NSAIDs (may reduce diuretic and antihypertensive effects, risk of renal impairment)
  • ACE inhibitors/ARBs (risk of profound hypotension and acute renal failure, especially with initial doses)
  • Digoxin (increased risk of digoxin toxicity due to hypokalemia)
  • Corticosteroids (increased risk of hypokalemia)
  • Neuromuscular blockers (potentiated effect due to hypokalemia)
  • Phenytoin (reduced diuretic effect of furosemide)
  • Sucralfate (reduced absorption of furosemide if given concurrently)
  • Antidiabetic agents (may decrease hypoglycemic effect)
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Minor Interactions

  • Other antihypertensives (additive hypotensive effect)
  • Probenecid (may reduce 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.

Timing: Prior to initiation of therapy

Renal Function (BUN, Serum Creatinine)

Rationale: To assess baseline kidney function and guide dosing.

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 hydration and severity of fluid overload.

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/bi-weekly depending on stability and dose.

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

Action Threshold: Potassium < 3.0 mEq/L (consider supplementation), Sodium < 130 mEq/L (consider fluid restriction/dose adjustment), Magnesium < 1.5 mEq/L (consider supplementation)

Renal Function (BUN, Serum Creatinine)

Frequency: Daily initially, then 2-3 times weekly, then weekly/bi-weekly depending on stability.

Target: Stable or improving

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

Blood Pressure

Frequency: Several times daily initially, then daily.

Target: Individualized, avoid symptomatic hypotension.

Action Threshold: Systolic BP < 90 mmHg or symptomatic hypotension.

Fluid Balance (Intake/Output, Daily Weight)

Frequency: Daily

Target: Negative fluid balance or weight loss as desired.

Action Threshold: Excessive weight loss (>2 kg/day) or signs of dehydration.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Muscle cramps or weakness
  • Nausea
  • Vomiting
  • Excessive thirst
  • Dry mouth
  • 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 has been shown to cause maternal and fetal abnormalities in animals at high doses. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but human data are limited. Avoid if possible.
Second Trimester: May be used if clearly needed, with careful monitoring of maternal fluid and electrolyte status.
Third Trimester: May cause electrolyte disturbances in the mother and fetus. Can 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 risk of adverse effects in the infant, but potential for dehydration or electrolyte imbalance. Monitor infant for signs of dehydration or electrolyte disturbance. May reduce milk supply.
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Pediatric Use

Dosing must be carefully individualized based on weight and clinical response. Neonates and infants may have prolonged half-life due to immature renal function. Risk of ototoxicity and nephrotoxicity, especially with concomitant aminoglycosides.

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Geriatric Use

Elderly patients may be more sensitive to the effects of furosemide, particularly hypotension and electrolyte disturbances. Start with lower doses and titrate slowly. More likely to have age-related decreases in renal function, requiring careful monitoring.

Clinical Information

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Clinical Pearls

  • Administer IV furosemide slowly (over 1-2 minutes for doses up to 40 mg, or 10-20 mg/min for higher doses) to minimize the risk of ototoxicity.
  • Rapid IV administration can cause transient hearing loss, especially in patients with renal impairment or those receiving other ototoxic drugs.
  • Monitor potassium levels closely; hypokalemia is a common and potentially serious side effect. Potassium supplementation or potassium-sparing diuretics may be needed.
  • Furosemide can cause photosensitivity; advise patients to use sun protection.
  • In patients with severe heart failure, continuous IV infusion may be more effective and cause fewer electrolyte shifts than intermittent bolus dosing.
  • For patients with ascites due to liver cirrhosis, furosemide should be used cautiously and often in combination with a potassium-sparing diuretic (e.g., spironolactone) to prevent hypokalemia and hepatic encephalopathy.
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Alternative Therapies

  • Bumetanide (another loop diuretic)
  • Torsemide (another loop diuretic)
  • Hydrochlorothiazide (thiazide diuretic, less potent)
  • Metolazone (thiazide-like diuretic, often used in combination with loop diuretics for refractory edema)
  • Spironolactone (potassium-sparing diuretic, often used in heart failure or liver disease)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage form per 10ml vial
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 proper 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 it occurred to ensure prompt and effective treatment.