Cefuroxime 500mg Tablets

Manufacturer AUROBINDO Active Ingredient Cefuroxime Tablets(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
Dec 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefuroxime is an antibiotic used to treat various bacterial infections, such as bronchitis, sinusitis, ear infections, skin infections, and urinary tract infections. It works by stopping the growth of bacteria. It is important to take this medication exactly as prescribed, usually with food, to help with absorption and reduce stomach upset.
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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. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Swallow the medication whole - do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor.

Continue taking your medication as instructed, even if your symptoms improve. Do not take antacids at the same time as this medication. If you have questions about taking antacids with this medication, ask your doctor for guidance.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. 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. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take cefuroxime tablets with food to improve absorption and reduce stomach upset.
  • Complete the full course of medication 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.
  • Avoid alcohol consumption as it may worsen gastrointestinal side effects, though no direct interaction is known.

Dosing & Administration

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Adult Dosing

Standard Dose: 500 mg orally twice daily
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 250 mg orally twice daily for 10 days
Acute Bacterial Maxillary Sinusitis: 250 mg orally twice daily for 10 days
Acute Bacterial Exacerbations of Chronic Bronchitis: 250 mg or 500 mg orally twice daily for 10 days
Secondary Bacterial Infections of Acute Bronchitis: 250 mg orally twice daily for 5-10 days
Uncomplicated Skin and Skin-Structure Infections: 250 mg or 500 mg orally twice daily for 10 days
Uncomplicated Urinary Tract Infections: 250 mg orally twice daily for 7-10 days
Uncomplicated Gonorrhea: 1000 mg orally as a single dose
Early Lyme Disease: 500 mg orally twice daily for 20 days
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Pediatric Dosing

Neonatal: Not established (use parenteral forms if indicated)
Infant: Not established for oral tablets (suspension available, e.g., 125 mg/5 mL or 250 mg/5 mL)
Child: Oral suspension typically used. For tablets (â‰Ĩ2 years old, able to swallow): Pharyngitis/Tonsillitis: 125 mg orally twice daily for 10 days. Acute Otitis Media/Acute Bacterial Maxillary Sinusitis: 250 mg orally twice daily for 10 days.
Adolescent: Same as adult dosing for specific indications, depending on weight and ability to swallow tablets.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-49 mL/min: No adjustment needed for standard doses.
Moderate: CrCl 10-29 mL/min: Administer standard individual dose every 24 hours.
Severe: CrCl <10 mL/min: Administer standard individual dose every 48 hours.
Dialysis: Hemodialysis: Administer standard individual dose at the end of each dialysis session. Peritoneal Dialysis: Not well studied, follow severe impairment guidelines.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

Pharmacology

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Mechanism of Action

Cefuroxime is a second-generation cephalosporin antibiotic. It exerts its bactericidal action by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which prevents the cross-linking of peptidoglycan chains, leading to the disruption of the cell wall and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 37% (fasted) to 52% (with food) for tablets
Tmax: 2-3 hours (with food)
FoodEffect: Absorption is increased when administered with food. Tablets should be taken with food for optimal absorption and to minimize gastrointestinal upset.

Distribution:

Vd: Approximately 9.3-15.8 L
ProteinBinding: 33-50%
CnssPenetration: Limited in the absence of meningeal inflammation; higher concentrations achieved with inflamed meninges.

Elimination:

HalfLife: Approximately 1.2-1.6 hours
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90% excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Rapid, typically within hours of first dose (clinical effect observed within 24-48 hours)
PeakEffect: Correlates with peak plasma concentrations (2-3 hours post-dose)
DurationOfAction: Maintained for 12 hours with twice-daily dosing due to sustained concentrations above MIC for susceptible organisms.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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
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, watery, or bloody (see below for more information on diarrhea)

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Other Possible Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Diarrhea
Upset stomach
Vomiting
Bad taste in your mouth

Reporting Side Effects

This is not a comprehensive list of all 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:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it occurs during or after treatment, which could be a sign of Clostridioides difficile-associated diarrhea (CDAD). Contact your doctor immediately.
  • Unusual bleeding or bruising.
  • Yellowing of the skin or eyes (jaundice), dark urine, or pale stools (signs of liver problems).
  • New signs of infection (e.g., fever, sore throat, vaginal yeast infection) which could indicate a superinfection.
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking probenecid.
* If you are taking any of the following medications: cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have, to your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust 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.

This drug has been associated with rare but 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.

Additionally, this medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you.

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

If you have phenylketonuria (PKU), discuss this with your doctor, as some formulations of this medication may contain phenylalanine.

Women taking birth control pills or other hormone-based contraceptives 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, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Increased neuromuscular excitability
  • Convulsions (seizures), especially in patients with renal impairment
  • Nausea
  • Vomiting
  • Diarrhea

What to Do:

In case of overdose, contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222. Treatment is largely supportive. Hemodialysis can aid in the removal of cefuroxime from the body.

Drug Interactions

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Major Interactions

  • Oral Contraceptives (estrogen/progestin combinations): May reduce efficacy of oral contraceptives. Advise use of alternative or additional birth control methods.
  • Probenecid: Increases cefuroxime plasma concentrations and prolongs its half-life by decreasing renal tubular secretion. Co-administration is generally not recommended unless specifically desired (e.g., for gonorrhea).
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Moderate Interactions

  • Antacids (containing aluminum or magnesium hydroxide): May decrease the bioavailability of cefuroxime axetil. Administer cefuroxime at least 1 hour before or 2 hours after antacids.
  • H2-receptor antagonists (e.g., ranitidine, cimetidine): May decrease the bioavailability of cefuroxime axetil. Administer cefuroxime at least 1 hour before or 2 hours after H2-receptor antagonists.
  • Proton Pump Inhibitors (e.g., omeprazole, lansoprazole): May decrease the bioavailability of cefuroxime axetil. Administer cefuroxime at least 1 hour before or 2 hours after PPIs.
  • Warfarin: Although rare, some cephalosporins have been associated with prolongation of prothrombin time. Monitor INR/PT if co-administered.
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Minor Interactions

  • Typhoid Vaccine (live, oral): Antibiotics, including cefuroxime, may inactivate the live bacterial vaccine. Avoid administration of typhoid vaccine within 3 days of cefuroxime.

Monitoring

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Baseline Monitoring

Culture and Susceptibility Testing

Rationale: To identify the causative pathogen and confirm its susceptibility to cefuroxime, ensuring appropriate therapy.

Timing: Prior to initiation of therapy, if clinically indicated.

Renal Function (BUN, Creatinine)

Rationale: To establish baseline renal function, especially in elderly patients or those with pre-existing renal impairment, as cefuroxime is primarily renally eliminated.

Timing: Before starting therapy in patients with suspected or known renal impairment.

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily during acute treatment, then as needed.

Target: Resolution of signs and symptoms of infection (e.g., fever reduction, decreased pain, improved inflammatory markers).

Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure, resistance, or alternative diagnosis, requiring re-evaluation.

Renal Function (BUN, Creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or those on prolonged therapy.

Target: Within patient's baseline or acceptable limits.

Action Threshold: Significant increase in BUN/creatinine may necessitate dose adjustment or discontinuation.

Signs of Superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: Throughout therapy and for several weeks post-treatment.

Target: Absence of new infections.

Action Threshold: Appearance of new symptoms requires investigation and appropriate management.

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Symptom Monitoring

  • Rash, itching, hives (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing (anaphylaxis)
  • Severe or watery diarrhea, abdominal pain, fever (Clostridioides difficile-associated diarrhea)
  • Unusual tiredness or weakness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, pale stools (liver dysfunction)
  • New or worsening signs of infection (superinfection)

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, and 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; use if clearly indicated.
Second Trimester: Generally considered low risk; use if clearly indicated.
Third Trimester: Generally considered low risk; use if clearly indicated.
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Lactation

Cefuroxime is excreted in human milk in small quantities. The amount ingested by the infant is generally considered 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

Cefuroxime tablets are not recommended for children who cannot swallow tablets whole. Oral suspension is available for younger children. Dosing is weight-based and indication-specific. Safety and efficacy have been established for various infections in pediatric patients aged 3 months to 12 years for suspension and â‰Ĩ2 years for tablets (depending on ability to swallow).

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment may be necessary in elderly patients with impaired renal function, as cefuroxime is primarily eliminated by the kidneys. Monitor renal function.

Clinical Information

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Clinical Pearls

  • Always advise patients to take cefuroxime tablets with food to enhance absorption and reduce GI upset.
  • Emphasize the importance of completing the entire course of antibiotics, even if symptoms improve, to prevent resistance and relapse.
  • Be aware of potential drug interactions with antacids, H2-blockers, and PPIs, which can reduce cefuroxime absorption. Advise spacing doses.
  • Counsel female patients on the potential for reduced efficacy of oral contraceptives and recommend alternative birth control methods during treatment.
  • Cefuroxime is a good option for respiratory tract infections, skin infections, and UTIs caused by susceptible organisms, including some beta-lactamase producing strains.
  • Consider C. difficile-associated diarrhea (CDAD) in patients presenting with diarrhea during or after cefuroxime therapy.
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Alternative Therapies

  • Other second-generation cephalosporins (e.g., Cefaclor, Cefprozil)
  • Third-generation cephalosporins (e.g., Cefdinir, Cefixime)
  • Penicillins (e.g., Amoxicillin, Amoxicillin/Clavulanate)
  • Macrolides (e.g., Azithromycin, Clarithromycin) for certain indications
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for specific indications and resistant organisms
  • Tetracyclines (e.g., Doxycycline) for specific indications
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic 500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 information. 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 details about the medication taken, the amount, and the time it happened.