Ceftin 500mg Tablets

Manufacturer GLAXO SMITH KLINE 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 and to finish the entire course, even if you start feeling better, to prevent the infection from returning.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, 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, take it with food to help minimize discomfort. Swallow the medication 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. 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 advice.

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 want to check if there are 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 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 to make up for a missed dose.
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Lifestyle & Tips

  • Take with food: Always take cefuroxime tablets with food to improve absorption and reduce stomach upset.
  • Complete the full course: Do not stop taking the medication early, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Stay hydrated: Drink plenty of fluids unless otherwise advised by your doctor.
  • Avoid alcohol: While not a direct interaction, alcohol can worsen gastrointestinal side effects.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg orally every 12 hours
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 250 mg every 12 hours for 10 days
Acute Bacterial Maxillary Sinusitis: 250 mg every 12 hours for 10 days
Acute Bacterial Exacerbations of Chronic Bronchitis: 250 mg or 500 mg every 12 hours for 10 days
Secondary Bacterial Infections of Acute Bronchitis: 250 mg every 12 hours for 5-10 days
Uncomplicated Skin and Skin Structure Infections: 250 mg or 500 mg every 12 hours for 10 days
Uncomplicated Urinary Tract Infections: 250 mg every 12 hours for 7-10 days
Uncomplicated Gonorrhea: 1000 mg as a single dose
Early Lyme Disease: 500 mg every 12 hours for 20 days
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Pediatric Dosing

Neonatal: Not established (safety and efficacy not established in infants less than 3 months of age)
Infant: Not established (safety and efficacy not established in infants less than 3 months of age)
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; Impetigo: 30 mg/kg/day in 2 divided doses (max 1000 mg/day) for 10 days.
Adolescent: Dosing typically follows adult recommendations based on weight and infection type.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 30 mL/min)
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 standard dose at the end of dialysis session. Peritoneal Dialysis: Administer standard dose every 48 hours.

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 inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding prevents the cross-linking of peptidoglycan chains, leading to the disruption of cell wall integrity and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 37% (tablets, fasting) to 52% (oral suspension, with food)
Tmax: 2-3 hours (tablets, with food)
FoodEffect: Food enhances the absorption of cefuroxime axetil, increasing bioavailability and peak plasma concentrations.

Distribution:

Vd: 9.3-15.8 L
ProteinBinding: 33-50%
CnssPenetration: Limited (penetrates inflamed meninges to a clinically significant extent)

Elimination:

HalfLife: 1.2-1.6 hours
Clearance: Not available (primarily renal)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 2-3 hours (peak plasma concentration)
DurationOfAction: 12 hours (due to BID dosing)

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 signs or 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 (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 right away. Before treating diarrhea, check with your doctor for advice.

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 unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach
Vomiting
Bad taste in your mouth

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 diarrhea (especially watery or bloody, which may occur up to several months after treatment)
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bleeding or bruising
  • Severe stomach pain or cramps
  • Vaginal itching or discharge (signs of yeast infection)
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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. Your doctor and pharmacist need this information to determine whether 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 can cause severe and potentially life-threatening allergic reactions, although such incidents are 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. Consider using an additional form of birth control, such as condoms, 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:

  • Cerebral irritation leading to convulsions (seizures)
  • Encephalopathy
  • Asterixis
  • Neuromuscular excitability

What to Do:

Call 1-800-222-1222 (Poison Control). In case of overdose, contact emergency services immediately. 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-containing): May reduce efficacy of oral contraceptives. Advise use of alternative or additional birth control method.
  • Probenecid: Increases cefuroxime plasma concentrations and prolongs its half-life by decreasing renal tubular secretion.
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Moderate Interactions

  • Antacids/H2-receptor antagonists/Proton Pump Inhibitors: May decrease the bioavailability of cefuroxime axetil by increasing gastric pH. Administer cefuroxime axetil at least 1 hour before or 2 hours after antacids.
  • Typhoid Vaccine (live, oral): Antibiotics, including cefuroxime, may inactivate the live bacterial vaccine. Avoid concurrent use or administer vaccine at least 24 hours after last antibiotic dose.
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Minor Interactions

  • Warfarin: Isolated reports of increased INR/PT. Monitor coagulation parameters.

Monitoring

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Baseline Monitoring

Culture and Susceptibility Testing

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

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

Renal Function (Serum Creatinine, BUN, CrCl)

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

Timing: Prior to initiation of therapy, especially in elderly patients or those with known renal dysfunction.

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Routine Monitoring

Signs and Symptoms of Infection

Frequency: Daily

Target: Resolution of fever, pain, inflammation, and other infection-specific symptoms.

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

Renal Function (Serum Creatinine, BUN)

Frequency: Periodically, especially in prolonged therapy or renal impairment

Target: Within patient's baseline or acceptable limits.

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

Complete Blood Count (CBC) with differential

Frequency: Periodically, especially in prolonged therapy

Target: Within normal limits; monitor for eosinophilia, neutropenia, or thrombocytopenia.

Action Threshold: Significant changes may indicate drug-induced hematologic abnormalities.

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Frequency: Periodically, especially in prolonged therapy

Target: Within normal limits.

Action Threshold: Significant elevation may indicate drug-induced hepatotoxicity.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, indicative of C. difficile-associated diarrhea)
  • Rash or itching (signs of hypersensitivity reaction)
  • Swelling of face, lips, tongue, or throat (signs of angioedema/anaphylaxis)
  • Difficulty breathing
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Persistent nausea or vomiting
  • New onset or worsening abdominal pain

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 major birth defects observed in human studies.
Second Trimester: Generally considered safe; no specific risks identified.
Third Trimester: Generally considered safe; no specific risks identified.
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Lactation

Cefuroxime is excreted in human milk in small amounts. The American Academy of Pediatrics considers cefuroxime compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (rash).

Infant Risk: Low risk. Potential for alteration of bowel flora, leading to diarrhea or candidiasis. Allergic sensitization is possible but rare.
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Pediatric Use

Safety and efficacy have been established for pediatric patients 3 months to 12 years of age for specific indications (pharyngitis/tonsillitis, acute otitis media, acute bacterial maxillary sinusitis, impetigo). Dosing is weight-based. Tablets are not recommended for children who cannot swallow them whole.

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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 is primarily based on renal function, which may be diminished in elderly patients.

Clinical Information

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Clinical Pearls

  • Cefuroxime axetil is a prodrug; it must be hydrolyzed to cefuroxime to be active. This hydrolysis is enhanced by food, so always advise patients to take tablets with food.
  • It is a second-generation cephalosporin, offering broader Gram-negative coverage than first-generation cephalosporins, including Haemophilus influenzae and Moraxella catarrhalis, making it useful for respiratory tract infections.
  • Unlike some other cephalosporins, cefuroxime does not require hepatic dose adjustment.
  • Be aware of potential false-positive results for urine glucose tests using copper reduction methods (e.g., Benedict's solution, Fehling's solution, Clinitestยฎ) and false-positive Coombs' tests.
  • Counsel patients on the importance of completing the full course of therapy to prevent resistance and relapse.
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Alternative Therapies

  • Amoxicillin/Clavulanate (Augmentin)
  • Azithromycin (Zithromax)
  • Clarithromycin (Biaxin)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Other second-generation cephalosporins (e.g., Cefaclor, Cefprozil)
  • Third-generation cephalosporins (e.g., Cefdinir, Cefixime)
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Cost & Coverage

Average Cost: $20 - $100 per 30 tablets (generic 500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.