Cefzil 500mg Tablets
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Second-generation Cephalosporin
Pregnancy Category
Category B
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefprozil is an antibiotic medication used to treat various bacterial infections, such as ear infections, sinus infections, throat infections (strep throat), bronchitis, and skin infections. It works by killing the bacteria that cause these infections.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. You can take this medication with or without food, but if it causes stomach upset, take it with food.
Storing and Disposing of Your Medication
Store the 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. 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, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. You can take this medication with or without food, but if it causes stomach upset, take it with food.
Storing and Disposing of Your Medication
Store the 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. 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, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing 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 the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance and recurrence of infection.
- Cefprozil can be taken with or without food. If it causes stomach upset, try taking it with food.
- Drink plenty of fluids to help prevent dehydration, especially if you experience diarrhea.
- Avoid alcohol consumption as it may worsen gastrointestinal side effects.
- Inform your doctor or pharmacist about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by infection type and severity. Common doses include 250 mg or 500 mg every 12 or 24 hours.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg once daily or 250 mg every 12 hours for 10 days
Acute Bacterial Sinusitis:
250 mg or 500 mg every 12 hours for 10 days
Acute Bacterial Exacerbation of Chronic Bronchitis:
500 mg every 12 hours for 10 days
Secondary Bacterial Infection of Acute Bronchitis:
500 mg every 12 hours for 10 days
Skin and Skin Structure Infections (uncomplicated):
250 mg or 500 mg every 12 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 6 months of age.
Child:
6 months to 12 years: 15 mg/kg/day divided every 12 hours for most infections (e.g., otitis media, skin/skin structure). Max 1000 mg/day. For pharyngitis/tonsillitis: 7.5 mg/kg every 12 hours for 10 days.
Adolescent:
13 years and older: Adult dosing applies.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 30 mL/min)
Moderate:
No adjustment needed (CrCl > 30 mL/min)
Severe:
Reduce dose by 50% (CrCl < 30 mL/min)
Dialysis:
Administer dose after hemodialysis session on dialysis days.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Cefprozil 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 cefprozil interferes with an autolysin inhibitor.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food delays Tmax by 0.25 to 0.75 hours but does not affect the extent of absorption (AUC) or peak plasma concentration (Cmax).
Distribution:
Vd:
0.21 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited (does not readily cross the intact blood-brain barrier in significant amounts; however, like other cephalosporins, it may penetrate inflamed meninges).
Elimination:
HalfLife:
1.1 to 1.4 hours
Clearance:
Not readily available as a single rate, but primarily renal.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 60-65% of the dose is excreted unchanged in the urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Correlates with peak plasma concentrations (Tmax)
DurationOfAction:
Sustained therapeutic concentrations for 12-24 hours depending on dosing frequency.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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
Seizures
Diarrhea, particularly if it is severe and accompanied by:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Note: Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment. If you experience any of these symptoms, contact your doctor promptly. Before treating diarrhea, consult with your doctor.
Other Possible 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 or any other symptoms that bother you or do not resolve, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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
Seizures
Diarrhea, particularly if it is severe and accompanied by:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Note: Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment. If you experience any of these symptoms, contact your doctor promptly. Before treating diarrhea, consult with your doctor.
Other Possible 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 or any other symptoms that bother you or do not resolve, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reaction: Hives, rash, itching, swelling of face/lips/tongue/throat, difficulty breathing or swallowing, dizziness, rapid heartbeat. Seek immediate medical attention.
- Severe or watery diarrhea, abdominal cramps, fever (especially if persistent or bloody): May be a sign of Clostridioides difficile-associated diarrhea (CDAD). Contact your doctor immediately.
- New signs of infection (e.g., white patches in mouth, vaginal itching/discharge): May indicate a superinfection (e.g., yeast infection).
- Unusual bruising or bleeding.
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you, as this medication may affect the results.
This drug may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection.
If you are 65 years or older, exercise caution when taking this drug, as you may be more susceptible to side effects.
If you are pregnant, planning 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.
If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you, as this medication may affect the results.
This drug may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection.
If you are 65 years or older, exercise caution when taking this drug, as you may be more susceptible to side effects.
If you are pregnant, planning 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.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- In rare cases, neurological effects such as seizures (especially in patients with renal impairment)
What to Do:
In case of suspected overdose, contact a poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention immediately. Treatment is primarily supportive; hemodialysis may be useful in removing cefprozil from the body.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., Typhoid vaccine, live): Cefprozil may decrease the therapeutic effect of live bacterial vaccines. Avoid concurrent use or administer vaccine at least 24 hours after last antibiotic dose.
Moderate Interactions
- Probenecid: Concomitant administration of probenecid with cefprozil increases the AUC of cefprozil by 50% and peak plasma levels by 31%.
- Oral anticoagulants (e.g., Warfarin): Cephalosporins may rarely enhance the anticoagulant effect of oral anticoagulants. Monitor INR/PT.
- Aminoglycosides: Although less common with cephalosporins than with penicillins, concurrent use with aminoglycosides may increase the risk of nephrotoxicity.
Monitoring
Baseline Monitoring
Renal function (CrCl, BUN, Creatinine)
Rationale: Cefprozil is primarily renally eliminated; dose adjustment is required in severe renal impairment.
Timing: Prior to initiation, especially in patients with known or suspected renal impairment.
Routine Monitoring
Signs and symptoms of infection resolution
Frequency: Daily during treatment
Target: Improvement or resolution of fever, pain, inflammation, etc.
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism; consider culture and sensitivity testing or alternative therapy.
Signs of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)
Frequency: Daily during and after treatment
Target: Absence of new infections
Action Threshold: Development of new infections, especially C. difficile-associated diarrhea, requires immediate evaluation and appropriate management.
Renal function (BUN, Creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or on prolonged therapy.
Target: Within patient's baseline or normal limits.
Action Threshold: Significant increase may require dose adjustment or discontinuation.
Symptom Monitoring
- Rash or hives (signs of allergic reaction)
- Difficulty breathing or swallowing (signs of severe allergic reaction)
- Severe or watery diarrhea, abdominal cramps, fever (signs of C. difficile-associated diarrhea)
- Nausea, vomiting, abdominal pain
- Headache, dizziness
- Vaginal itching or discharge (yeast infection)
- White patches in mouth (oral thrush)
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Limited data in pregnant women suggest no increased risk of major birth defects or miscarriage. Generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and limited human data.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Cefprozil is excreted in human milk in very low concentrations. The amount ingested by a breastfed infant is small and generally not expected to cause adverse effects. Monitor the infant for potential changes in bowel flora (e.g., diarrhea, candidiasis/thrush). Considered compatible with breastfeeding by most experts.
Infant Risk:
Low risk
Pediatric Use
Cefprozil is safe and effective for the treatment of indicated infections in pediatric patients 6 months of age and older. Dosing is weight-based. Safety and effectiveness in infants younger than 6 months have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is generally not necessary based on age alone, but renal function should be assessed, as elderly patients are more likely to have decreased renal function.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens (e.g., S. pneumoniae, H. influenzae, M. catarrhalis) and skin pathogens (e.g., S. aureus, S. pyogenes).
- It is often a good choice for community-acquired respiratory tract infections and uncomplicated skin and skin structure infections.
- Unlike some other cephalosporins, cefprozil has minimal metabolism, with most of the drug excreted unchanged in the urine.
- Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent the development of antibiotic resistance.
- Counsel patients on potential gastrointestinal side effects (diarrhea, nausea) and the importance of reporting severe or persistent diarrhea.
Alternative Therapies
- Other second-generation cephalosporins (e.g., cefuroxime, cefaclor)
- First-generation cephalosporins (e.g., cephalexin, cefadroxil) for skin/soft tissue infections or strep throat
- Third-generation cephalosporins (e.g., cefdinir, cefixime) for respiratory tract infections
- Penicillins (e.g., amoxicillin, amoxicillin/clavulanate)
- Macrolides (e.g., azithromycin, clarithromycin) for patients with penicillin allergy or atypical pathogens
- Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for certain respiratory or skin infections (consider resistance patterns and side effects)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 tablets (generic 500mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount, and the time it occurred.