Cefuroxime 1.5gm Inj, 1 Vial

Manufacturer SAGENT PHARMACEUTICAL Active Ingredient Cefuroxime Injection(se fyoor OKS eem) Pronunciation se fyoor OKS eem
It is used to treat or prevent bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Second-generation Cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Mar 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefuroxime is an antibiotic that fights bacteria in your body. It's used to treat various bacterial infections like pneumonia, skin infections, urinary tract infections, and more. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered either as an injection into a muscle or as an infusion into a vein over a period of time. In some cases, it may be given as an injection directly into a vein.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Stay well-hydrated unless otherwise instructed by your doctor.
  • Complete the full course of treatment as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Do not share this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 750 mg to 1.5 g IV/IM every 8 hours
Dose Range: 750 - 1500 mg

Condition-Specific Dosing:

uncomplicatedUTI: 750 mg IV/IM every 8 hours
severeInfections: 1.5 g IV every 8 hours
surgicalProphylaxis: 1.5 g IV 30-60 minutes prior to incision, then 750 mg IV/IM every 8 hours for 24 hours if needed
gonorrhea: 1.5 g IM as a single dose (given as two 750 mg injections at different sites)
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Pediatric Dosing

Neonatal: Not established (use with caution, consider alternative)
Infant: 50-100 mg/kg/day IV/IM in divided doses every 6-8 hours (max 100 mg/kg/day)
Child: 50-100 mg/kg/day IV/IM in divided doses every 6-8 hours (max 6 g/day)
Adolescent: Same as adult dosing for specific indications
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Dose Adjustments

Renal Impairment:

Mild: CrCl >50 mL/min: No adjustment needed
Moderate: CrCl 10-50 mL/min: 750 mg every 12 hours
Severe: CrCl <10 mL/min: 750 mg every 24 hours
Dialysis: Hemodialysis: 750 mg at the end of each dialysis session. Peritoneal Dialysis: 750 mg every 24 hours.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Cefuroxime is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby inhibiting the transpeptidation step of peptidoglycan synthesis. This leads to the disruption of the cell wall, resulting in cell lysis and bacterial death.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: Immediate (IV); 30-60 minutes (IM)
FoodEffect: Not applicable for injection

Distribution:

Vd: 9.3-15.8 L (adults)
ProteinBinding: 33-50%
CnssPenetration: Limited (can penetrate inflamed meninges)

Elimination:

HalfLife: 1-1.5 hours (normal renal function)
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV administration)
PeakEffect: Within 1 hour (IV/IM)
DurationOfAction: Approximately 8 hours (based on dosing frequency)
Confidence: Medium

Safety & Warnings

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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 medical attention immediately:

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
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Dark urine or yellowing of the skin or eyes
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Vaginal itching or discharge
Hearing loss
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (this could be a sign of a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD)

Common Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Upset stomach
Vomiting
Irritation at the injection site

Reporting 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:

  • Signs of a severe allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness.
  • Severe or watery diarrhea, especially if it occurs days or weeks after stopping the medication (could be C. difficile infection).
  • Unusual bleeding or bruising.
  • Yellowing of the skin or eyes (jaundice).
  • Signs of kidney problems: decreased urination, swelling in your ankles or feet.
  • 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:

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 are currently taking probenecid, as this may interact with the medication.

Additionally, to ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

This information will help your doctor determine if it is safe for you to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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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.

Rarely, drugs like this one can cause severe and potentially life-threatening allergic reactions.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you have diabetes and test your urine glucose levels, consult with your doctor to determine the most suitable tests to use.

Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection.

If you are using birth control pills or other hormone-based contraceptives, you should be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using an additional form of birth control, such as a condom, while taking this drug.

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, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Brain irritation leading to convulsions (seizures)
  • Encephalopathy
  • Neuromuscular excitability

What to Do:

Seek immediate medical attention. Overdose is primarily managed with supportive care. Hemodialysis can aid in the removal of cefuroxime from the body. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Live bacterial vaccines (e.g., BCG, typhoid oral): May reduce therapeutic effect of vaccine.
  • Sodium picosulfate: May reduce the laxative effect of sodium picosulfate.
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Moderate Interactions

  • Aminoglycosides: Increased risk of nephrotoxicity (monitor renal function).
  • Loop diuretics (e.g., furosemide): Increased risk of nephrotoxicity when co-administered with aminoglycosides.
  • Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect (monitor INR).
  • Probenecid: Decreases renal tubular secretion of cefuroxime, leading to increased and prolonged serum concentrations of cefuroxime.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Cefuroxime is primarily renally excreted; dosage adjustment is required in renal impairment.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Although not primarily metabolized by the liver, baseline assessment is prudent.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential hematologic adverse effects.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily

Target: Improvement in fever, WBC count, localized symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.

Renal function (BUN, creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or on concomitant nephrotoxic drugs

Target: Within patient's baseline or acceptable limits

Action Threshold: Significant increase may require dose adjustment or discontinuation.

INR (if on warfarin)

Frequency: More frequently during co-administration

Target: Therapeutic range for indication

Action Threshold: INR outside target range requires dose adjustment of anticoagulant.

Signs of adverse reactions (e.g., rash, diarrhea, injection site reactions)

Frequency: Daily

Target: Absence of adverse effects

Action Threshold: Presence of severe or persistent adverse effects may require discontinuation.

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Symptom Monitoring

  • Rash or hives (signs of allergic reaction)
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Severe or watery diarrhea, abdominal pain, fever (signs of Clostridioides difficile-associated diarrhea)
  • Unusual bleeding or bruising (potential effect on coagulation)
  • Yellowing of skin or eyes, dark urine (signs of liver problems)
  • Decreased urine output, swelling (signs of kidney problems)
  • Injection site pain, redness, or swelling

Special Patient Groups

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Pregnancy

Cefuroxime is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Generally considered low risk, but use only if clearly indicated.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Cefuroxime is excreted in human milk in small quantities. The amount ingested by the infant is generally considered to be low and unlikely to cause significant adverse effects. Monitor breastfed infants for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk (L2)
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Pediatric Use

Dosing must be carefully calculated based on weight and age, and adjusted for renal function. Neonatal use is generally not recommended due to limited data and potential for bilirubin displacement.

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Geriatric Use

Elderly patients are more likely to have decreased renal function, which may require dosage adjustment. Monitor renal function closely. Otherwise, no specific age-related precautions beyond those for adults.

Clinical Information

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Clinical Pearls

  • Cefuroxime is a second-generation cephalosporin with good activity against common respiratory pathogens (e.g., H. influenzae, M. catarrhalis, S. pneumoniae) and some Gram-negative bacteria.
  • It is often used for community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, skin and soft tissue infections, and urinary tract infections.
  • For surgical prophylaxis, administer 30-60 minutes prior to incision.
  • IM injections should be given deep into a large muscle mass (e.g., gluteus or lateral thigh) to minimize pain.
  • Reconstituted solutions should be used promptly; refer to package insert for specific stability data.
  • Patients with a history of severe hypersensitivity to penicillin should generally avoid cefuroxime due to potential cross-reactivity, though it is lower than with first-generation cephalosporins.
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Alternative Therapies

  • Other second-generation cephalosporins (e.g., cefaclor, cefoxitin)
  • Third-generation cephalosporins (e.g., ceftriaxone, cefotaxime)
  • Penicillins (e.g., amoxicillin/clavulanate)
  • Macrolides (e.g., azithromycin, clarithromycin)
  • Fluoroquinolones (e.g., levofloxacin, moxifloxacin)
  • Carbapenems (for broader spectrum or resistant infections)
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Cost & Coverage

Average Cost: Varies widely by supplier and contract per 1.5g vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.