Cefprozil 500mg Tablets
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Second-generation Cephalosporin, Beta-lactam Antibiotic
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), and skin infections. It works by killing the bacteria that cause these infections. It is important to take the full course of medication as prescribed, even if you start feeling better, to ensure the infection is completely cleared and to prevent antibiotic resistance.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
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 have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
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 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 the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
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 have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
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 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 the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better.
- Cefprozil can be taken with or without food.
- If you are taking the liquid suspension, shake it well before each use and use a measuring spoon or cup for accurate dosing.
- Store the liquid suspension in the refrigerator and discard any unused portion after 14 days.
- Report any severe or persistent diarrhea to your doctor, as it could be a sign of a more serious infection (Clostridioides difficile-associated diarrhea).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg orally every 12 or 24 hours, depending on indication
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg orally every 24 hours for 10 days
Acute Bacterial Sinusitis:
250 mg orally every 12 hours for 10 days (mild-moderate) or 500 mg orally every 12 hours for 10 days (severe)
Skin and Skin Structure Infections (uncomplicated):
250 mg orally every 12 hours or 500 mg orally every 24 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants < 6 months
Child:
Acute Otitis Media (6 months to 12 years): 15 mg/kg orally every 12 hours for 10 days; Pharyngitis/Tonsillitis (2 to 12 years): 7.5 mg/kg orally every 12 hours or 15 mg/kg orally every 24 hours for 10 days; Skin and Skin Structure Infections (2 to 12 years): 20 mg/kg orally every 24 hours for 10 days
Adolescent:
Dosing typically follows adult recommendations for adolescents weighing > 45 kg
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 after dialysis sessions 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 last 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 90%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be delayed by 30-60 minutes.
Distribution:
Vd:
0.21 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited (poor penetration into CSF)
Elimination:
HalfLife:
1.3 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 60% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Rapid
PeakEffect:
Within 1.5 hours (plasma concentration)
DurationOfAction:
Dependent on MIC of pathogen and dosing frequency (typically maintains therapeutic levels for 12-24 hours)
Safety & Warnings
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 immediate medical attention:
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
Seizures
Diarrhea that is severe, watery, or bloody, or accompanied by stomach pain or cramps, which could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD). CDAD may occur during or several months after taking antibiotics.
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's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Upset stomach
* Diarrhea
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and guidance on managing side effects.
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 immediate medical attention:
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
Seizures
Diarrhea that is severe, watery, or bloody, or accompanied by stomach pain or cramps, which could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD). CDAD may occur during or several months after taking antibiotics.
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's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Upset stomach
* Diarrhea
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reaction (rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing)
- Severe or watery diarrhea, especially if it contains blood or mucus, or is accompanied by fever or abdominal cramps
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Signs of new infection (e.g., oral thrush, vaginal yeast infection)
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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method, as this medication may affect the accuracy of certain tests. Additionally, be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may impact the results of certain lab tests.
Do not take this medication for longer than prescribed, as this can increase the risk of developing a secondary infection. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method, as this medication may affect the accuracy of certain tests. Additionally, be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may impact the results of certain lab tests.
Do not take this medication for longer than prescribed, as this can increase the risk of developing a secondary infection. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for 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 immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is primarily supportive and symptomatic. Hemodialysis may be useful in removing cefprozil from the body in cases of severe overdose with renal impairment.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., typhoid vaccine): May decrease therapeutic effect of vaccine.
Moderate Interactions
- Probenecid: May increase and prolong cefprozil serum concentrations.
- Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect (monitor INR).
- Aminoglycosides: Potential for increased nephrotoxicity (though less common with cephalosporins than with aminoglycosides alone).
Minor Interactions
- Loop diuretics (e.g., furosemide): May increase risk of nephrotoxicity, especially in patients with pre-existing renal impairment.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, BUN, CrCl)
Rationale: Cefprozil is primarily renally eliminated; dose adjustment is required in severe renal impairment.
Timing: Prior to initiation, especially in elderly or renally impaired patients.
Routine Monitoring
Clinical response to therapy (resolution of signs/symptoms of infection)
Frequency: Daily during acute treatment
Target: Improvement within 2-3 days
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.
Signs/symptoms of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)
Frequency: Daily throughout treatment and for several weeks post-treatment
Target: Absence of new infections
Action Threshold: Development of new infections requires evaluation and appropriate treatment.
Complete Blood Count (CBC) with differential
Frequency: Periodically, especially during prolonged therapy
Target: Within normal limits
Action Threshold: Significant changes (e.g., eosinophilia, leukopenia, thrombocytopenia) may indicate drug-induced hematologic effects.
Liver function tests (ALT, AST, ALP, Bilirubin)
Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing liver disease
Target: Within normal limits
Action Threshold: Significant elevations may indicate drug-induced hepatotoxicity.
Symptom Monitoring
- Diarrhea (especially severe or persistent, may indicate Clostridioides difficile-associated diarrhea)
- Rash, itching, hives (signs of allergic reaction)
- Swelling of face, lips, tongue, or throat (signs of angioedema/anaphylaxis)
- Nausea, vomiting, abdominal pain
- Headache, dizziness
- Joint pain
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies.
Second Trimester:
No specific risks identified beyond general pregnancy considerations.
Third Trimester:
No specific risks identified beyond general pregnancy considerations.
Lactation
Cefprozil is excreted in human milk in very low concentrations. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
L2 - Likely compatible. Low risk of adverse effects in breastfed infants.
Pediatric Use
Cefprozil is generally safe and effective for use in pediatric patients 6 months of age and older for approved indications. 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 recommended for elderly patients with significant renal impairment.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens, including *Streptococcus pneumoniae*, *Haemophilus influenzae*, and *Moraxella catarrhalis*.
- It is often a good choice for community-acquired respiratory tract infections and uncomplicated skin infections.
- Patients should be advised to complete the entire course of therapy to prevent the development of antibiotic resistance.
- Counsel patients on the signs and symptoms of *Clostridioides difficile*-associated diarrhea (CDAD) and to seek medical attention if it occurs.
- While generally well-tolerated, gastrointestinal side effects (diarrhea, nausea, vomiting) are common.
Alternative Therapies
- Other second-generation cephalosporins (e.g., cefuroxime, cefaclor)
- Other beta-lactam antibiotics (e.g., amoxicillin, amoxicillin/clavulanate)
- Macrolide antibiotics (e.g., azithromycin, clarithromycin) for patients with penicillin allergy
- Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for specific indications or resistant organisms
Cost & Coverage
Average Cost:
$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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.