Cefuroxime 250mg Tablets

Manufacturer AUROBINDO PHARMA 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
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 medication used to treat a variety of bacterial infections, such as bronchitis, sinusitis, ear infections, skin infections, and urinary tract infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, taking it with food may help. Swallow the tablet whole - do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.

Continue taking your medication as directed, even if your symptoms improve. It's also important to note that you should not take antacids at the same time as this medication. If you have questions about taking antacids with this medication, ask your doctor for advice.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or check if there are any drug take-back programs in your area.

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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take this medication with food to help your body absorb it better and to reduce stomach upset.
  • Complete the entire course of medication as prescribed by your doctor, even if you start to feel better. Stopping early can lead to the infection returning and bacteria becoming resistant to antibiotics.
  • Do not share this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg twice daily
Dose Range: 125 - 1000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 250 mg twice daily for 10 days
Acute Bacterial Maxillary Sinusitis: 250 mg twice daily for 10 days
Acute Bacterial Exacerbation of Chronic Bronchitis: 250-500 mg twice daily for 10 days
Uncomplicated Skin/Skin Structure Infections: 250-500 mg twice daily for 10 days
Uncomplicated Urinary Tract Infection: 125-250 mg twice daily for 7-10 days
Uncomplicated Gonorrhea: 1000 mg as a single dose
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (oral suspension for children >3 months)
Child: Pharyngitis/Tonsillitis: 20 mg/kg/day in 2 divided doses (max 500 mg/day) for 10 days; Acute Otitis Media/Acute Bacterial Maxillary Sinusitis: 30 mg/kg/day in 2 divided doses (max 1000 mg/day) for 10 days
Adolescent: Same as adult dosing for specific indications
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-49 mL/min: Administer standard dose every 12-24 hours
Moderate: CrCl 10-29 mL/min: Administer standard dose every 24 hours
Severe: CrCl <10 mL/min: Administer standard dose every 48 hours
Dialysis: Hemodialysis: Administer dose after dialysis; Peritoneal Dialysis: Not well studied, generally 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 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 third and final stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefuroxime interferes with an autolysin inhibitor.
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Pharmacokinetics

Absorption:

Bioavailability: 37% (fasted), 52% (with food) for oral tablets
Tmax: 2-3 hours
FoodEffect: Enhanced absorption with food; tablets should be taken with food for optimal absorption.

Distribution:

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

Elimination:

HalfLife: 1.2-1.6 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 89% excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Correlates with Tmax (2-3 hours)
DurationOfAction: Dependent on dosing interval and MIC of pathogen (typically maintains therapeutic levels for 8-12 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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, 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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
Bad taste in your mouth

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 or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
  • Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing
  • Severe stomach pain or cramps
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
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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 allergic reaction you experienced, including the symptoms that occurred.
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 drug interactions or health problems that may be relevant to this medication.

To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, share any health problems you have with your doctor. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 can cause severe and potentially life-threatening allergic reactions, although this is rare. 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 test your urine for glucose, consult with your doctor to determine the most suitable testing method.

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, use 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, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Neuromuscular excitability (e.g., tremors, myoclonus)
  • Convulsions (seizures)
  • Encephalopathy

What to Do:

In case of overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is primarily supportive. Hemodialysis may be useful in removing cefuroxime from the body.

Drug Interactions

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Moderate Interactions

  • Antacids/H2-receptor antagonists/Proton pump inhibitors (PPIs)
  • Probenecid
  • Oral Contraceptives
  • Warfarin

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, CrCl)

Rationale: Cefuroxime is primarily renally eliminated; baseline assessment is crucial for dose adjustment in patients with impaired renal function.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistant organism, or alternative diagnosis.

Signs and symptoms of superinfection (e.g., C. difficile-associated diarrhea, oral/vaginal candidiasis)

Frequency: Daily throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new or worsening diarrhea, fever, abdominal pain, or white patches in mouth/vagina requires investigation and appropriate management.

Renal function (Serum Creatinine, CrCl)

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

Target: Stable renal function

Action Threshold: Significant increase in serum creatinine or decrease in CrCl may necessitate dose adjustment or discontinuation.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, may indicate C. difficile infection)
  • Rash, itching, hives (signs of allergic reaction)
  • Fever, chills (may indicate worsening infection or drug reaction)
  • Nausea, vomiting, abdominal pain
  • Headache, dizziness

Special Patient Groups

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Pregnancy

Cefuroxime is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk 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: No increased risk of congenital anomalies observed in human studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Cefuroxime is excreted in human milk in small amounts. It is generally considered compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk
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Pediatric Use

Oral cefuroxime axetil tablets are not recommended for children younger than 3 months of age. Dosing for older pediatric patients is weight-based and varies by indication. Oral suspension is available for easier administration in younger children.

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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. Dosage adjustment may be necessary in elderly patients with impaired renal function.

Clinical Information

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Clinical Pearls

  • Always advise patients to take cefuroxime axetil tablets with food to maximize absorption and minimize gastrointestinal upset.
  • Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
  • Be aware of potential drug interactions, especially with gastric acid suppressants (antacids, H2 blockers, PPIs), which can significantly reduce cefuroxime absorption.
  • Cefuroxime is a second-generation cephalosporin, offering broader coverage than first-generation agents, including activity against Haemophilus influenzae and Moraxella catarrhalis, making it useful for respiratory tract infections.
  • Counsel patients on the signs of C. difficile-associated diarrhea and to seek medical attention if it occurs.
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Alternative Therapies

  • Other cephalosporins (e.g., Cefaclor, Cefdinir, Cefpodoxime)
  • Penicillins (e.g., Amoxicillin, Amoxicillin/Clavulanate)
  • Macrolides (e.g., Azithromycin, Clarithromycin)
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - generally reserved for specific indications due to resistance and side effect profiles
  • Tetracyclines (e.g., Doxycycline)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (250mg generic)
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'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.