Cefprozil 250mg 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), 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 to feel better. 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. 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 medications, consult your pharmacist. You may also want to check if there are 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'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 to feel better. 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. 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 medications, consult your pharmacist. You may also want to check if there are 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'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 you are taking the liquid suspension, shake it well before each use and use a measuring spoon or cup to ensure the correct dose.
- Store the liquid suspension in the refrigerator and discard any unused portion after 14 days.
- Avoid alcohol consumption as it may worsen gastrointestinal side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg every 12 or 24 hours, depending on infection type and severity
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg once daily for 10 days
Acute Bacterial Sinusitis:
250 mg every 12 hours for 10 days (mild-moderate) or 500 mg every 12 hours for 10 days (moderate-severe)
Acute Bronchitis (secondary bacterial infection):
500 mg every 12 hours for 10 days
Skin and Skin Structure Infections (uncomplicated):
250 mg every 12 hours or 500 mg once daily for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally > 6 months)
Child:
6 months to 12 years: 15 mg/kg/day divided every 12 hours for pharyngitis/tonsillitis (max 500 mg/day); 30 mg/kg/day divided every 12 hours for otitis media, sinusitis, skin infections (max 1000 mg/day)
Adolescent:
Generally adult dosing applies for adolescents weighing > 45 kg or > 12 years old.
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 session on dialysis days. Reduce dose by 50%.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
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 transpeptidation step of peptidoglycan synthesis. This leads to the disruption of the cell wall, resulting in bacterial cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 to 2 hours
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be slightly delayed.
Distribution:
Vd:
0.21 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited (does not achieve therapeutic concentrations in CSF)
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 60% of the dose is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Correlates with Tmax (1.5-2 hours)
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours), maintaining concentrations above MIC.
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:
- 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, watery diarrhea, especially if it contains blood or mucus, or is accompanied by fever and abdominal cramps. This could be a sign of Clostridioides difficile-associated diarrhea (CDAD), which can occur even weeks after stopping the antibiotic.
- New or worsening symptoms of infection after starting the medication.
- 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 identify potential interactions between this medication and other substances.
* Any health problems you have, 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 other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 identify potential interactions between this medication and other substances.
* Any health problems you have, 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 other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 accuracy of certain tests.
Additionally, this drug may interfere with the results of 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 breastfeeding, it is essential 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 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 accuracy of certain tests.
Additionally, this drug may interfere with the results of 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 breastfeeding, it is essential 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 like 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 generally supportive and symptomatic. Hemodialysis may be useful in removing cefprozil from the body, especially in patients with impaired renal function.
Drug Interactions
Major Interactions
- Warfarin (increased INR/bleeding risk)
Moderate Interactions
- Probenecid (increases cefprozil plasma concentrations and prolongs half-life)
- Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins than with penicillins)
- Oral Contraceptives (theoretical reduction in efficacy, though not consistently proven for cephalosporins)
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, CrCl)
Rationale: To determine appropriate dosing, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response to therapy (e.g., resolution of fever, reduction in symptoms)
Frequency: Daily
Target: Improvement of infection symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism.
Signs of superinfection (e.g., oral thrush, vaginal candidiasis, new onset diarrhea)
Frequency: Throughout therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: Development of new symptoms requires evaluation and potential treatment.
Bowel movements (for C. difficile-associated diarrhea)
Frequency: Daily, especially if diarrhea develops
Target: Normal bowel habits
Action Threshold: Persistent, severe diarrhea, especially with fever or abdominal pain, warrants C. difficile testing.
Symptom Monitoring
- Rash
- Hives
- Itching
- Swelling (face, lips, tongue, throat)
- Difficulty breathing or swallowing (signs of allergic reaction)
- Severe or persistent diarrhea
- Abdominal pain or cramps
- Nausea
- Vomiting
- Headache
- Dizziness
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 antibiotic use.
Third Trimester:
No specific risks identified beyond general antibiotic use.
Lactation
Cefprozil is excreted in human milk in very low concentrations. While generally considered compatible with breastfeeding, caution should be exercised. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk (L2 - Safer drug)
Pediatric Use
Cefprozil is approved for use 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 primarily based on renal function, which may be diminished in elderly patients. Monitor renal function.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin effective against a range of Gram-positive and some Gram-negative bacteria, including common respiratory pathogens like S. pneumoniae, H. influenzae, and M. catarrhalis.
- It is a good option for community-acquired respiratory tract infections and uncomplicated skin infections when a broader spectrum than first-generation cephalosporins is desired.
- Counsel patients to complete the entire course of therapy to prevent the development of antibiotic resistance.
- Advise patients to report any severe or persistent diarrhea, as it could indicate C. difficile infection.
- While food does not significantly impact absorption, taking it with food may help reduce gastrointestinal upset in some patients.
Alternative Therapies
- Amoxicillin
- Amoxicillin/Clavulanate
- Azithromycin
- Clarithromycin
- Cefdinir
- Cefuroxime
- Levofloxacin
- Moxifloxacin
- Doxycycline
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred 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's a good idea 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. They can provide you with personalized guidance and support.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
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's a good idea 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. They can provide you with personalized guidance and support.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.