Cefprozil 125mg/5ml Susp 50ml
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, and skin infections. It works by stopping the growth of bacteria. 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 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 to help minimize this side effect.
Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store this medication in the refrigerator to maintain its potency. Discard any unused portion after 2 weeks. Do not freeze the medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
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 a missed dose.
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 to help minimize this side effect.
Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store this medication in the refrigerator to maintain its potency. Discard any unused portion after 2 weeks. Do not freeze the medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
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 a missed dose.
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.
- Shake the oral suspension well before each use.
- Use a calibrated measuring spoon or cup for accurate dosing, not a household spoon.
- Cefprozil can be taken with or without food. If it causes stomach upset, taking it with food may help.
- Store the oral suspension in the refrigerator after reconstitution and discard any unused portion after 14 days.
- Avoid alcohol consumption, as it may worsen gastrointestinal side effects, although no direct interaction is reported.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by infection type and severity. Common doses include 500 mg every 12-24 hours.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg every 24 hours
Acute Bacterial Sinusitis:
250 mg every 12 hours or 500 mg every 24 hours
Acute Bronchitis:
500 mg every 12 hours
Skin and Skin Structure Infections (uncomplicated):
250 mg every 12 hours or 500 mg every 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
6 months to 12 years: Pharyngitis/Tonsillitis: 20 mg/kg/day once daily or 7.5 mg/kg every 12 hours. Acute Otitis Media: 15 mg/kg every 12 hours. Acute Sinusitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours. Skin/Skin Structure: 20 mg/kg every 24 hours.
Child:
6 months to 12 years: Pharyngitis/Tonsillitis: 20 mg/kg/day once daily or 7.5 mg/kg every 12 hours. Acute Otitis Media: 15 mg/kg every 12 hours. Acute Sinusitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours. Skin/Skin Structure: 20 mg/kg every 24 hours. Max dose 1000 mg/day.
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 dialysis session. Hemodialysis removes approximately 60% of cefprozil over 3-4 hours.
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 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 may delay Tmax by 30-45 minutes but does not affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 0.23 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited (does not achieve therapeutically relevant concentrations in CSF)
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Not specifically quantified as a single rate, but primarily renal.
ExcretionRoute:
Renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 60% of the dose is excreted unchanged in the urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 1.5 hours of administration
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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, especially if it is severe, bloody, or accompanied by stomach pain or cramps. This could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD), which may occur during or after treatment with 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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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.
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 medical help right away:
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, especially if it is severe, bloody, or accompanied by stomach pain or cramps. This could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD), which may occur during or after treatment with 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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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.
Seek Immediate Medical Attention If You Experience:
- Severe diarrhea (watery or bloody stools), especially if accompanied by fever or abdominal cramps, which may indicate Clostridioides difficile-associated diarrhea (CDAD).
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Unusual bruising or bleeding.
- Yellowing of the skin or eyes (jaundice), dark urine, or pale stools (signs of liver problems).
- Fever, sore throat, or other signs of new infection (superinfection).
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 this medication can be taken safely with all your other 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 this medication can be taken safely with all your other 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.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Do not use 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.
Older adults (65 years and older) should exercise caution when using this medication, as they 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.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Do not use 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.
Older adults (65 years and older) should exercise caution when using this medication, as they 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.
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 overdose, contact a poison control center immediately or seek emergency medical attention. Treatment is primarily supportive and symptomatic. Hemodialysis may be useful in removing cefprozil from the body, especially in patients with impaired renal function.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., BCG, typhoid oral): Cefprozil may reduce the therapeutic effect of these vaccines. Avoid concurrent use or administer vaccine after antibiotic course.
Moderate Interactions
- Probenecid: May increase and prolong cefprozil serum concentrations by decreasing renal tubular secretion.
- Aminoglycosides: Concurrent use with cephalosporins may increase the risk of nephrotoxicity, especially in patients with pre-existing renal impairment.
- Oral Anticoagulants (e.g., Warfarin): Cephalosporins may alter gut flora, potentially affecting vitamin K synthesis and enhancing the anticoagulant effect. Monitor INR/PT closely.
- Metformin: Cephalosporins may increase metformin concentrations by inhibiting renal tubular secretion. Monitor for metformin-related adverse effects.
Minor Interactions
- Loop Diuretics (e.g., Furosemide): May increase the risk of nephrotoxicity with cephalosporins, particularly in patients with renal impairment.
Monitoring
Baseline Monitoring
Culture and Susceptibility Testing
Rationale: To identify the causative pathogen and confirm its susceptibility to cefprozil, guiding appropriate therapy.
Timing: Prior to initiating therapy, if clinically indicated.
Renal Function (BUN, Creatinine)
Rationale: To establish baseline renal status, as cefprozil is primarily renally eliminated and dose adjustment is required in severe renal impairment.
Timing: Prior to initiating therapy, especially in patients with suspected or known renal impairment.
Routine Monitoring
Clinical Response (resolution of signs/symptoms of infection)
Frequency: Daily during acute treatment, then as needed until completion of therapy.
Target: Improvement in fever, pain, inflammation, and other infection-specific symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or alternative diagnosis, requiring re-evaluation.
Signs of Superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)
Frequency: Daily throughout therapy and for several weeks post-therapy.
Target: Absence of new infections.
Action Threshold: Development of new or worsening symptoms suggestive of superinfection (e.g., 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 those receiving concomitant nephrotoxic drugs.
Target: Stable within patient's baseline or acceptable limits.
Action Threshold: Significant increase in BUN/creatinine may necessitate dose adjustment or discontinuation.
Symptom Monitoring
- Diarrhea (especially severe or persistent, which could indicate C. difficile infection)
- Nausea/Vomiting
- Abdominal pain
- Skin rash or itching (signs of allergic reaction)
- Hives
- Difficulty breathing or swallowing (signs of severe allergic reaction)
- Unusual tiredness or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Pale stools
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Human studies are limited, but available data do not suggest an increased risk of major birth defects or other adverse outcomes. Generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies or limited human data.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Cefprozil is excreted in human milk in very low concentrations. The amount ingested by a breastfed infant is generally considered to be low and unlikely to cause adverse effects. Monitor infants for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions (e.g., rash). Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects; monitor for diarrhea, candidiasis, or allergic reactions.
Pediatric Use
Cefprozil oral suspension is approved for use in pediatric patients 6 months of age and older. Dosing is weight-based and varies by indication. Safety and efficacy 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. Dose adjustment is necessary in elderly patients with significant renal impairment.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens, including Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.
- It is often a good choice for community-acquired respiratory tract infections and skin/skin structure infections.
- The oral suspension must be refrigerated after reconstitution and discarded after 14 days.
- Patients should be advised to complete the entire course of therapy to prevent the development of antibiotic resistance.
- While generally well-tolerated, gastrointestinal side effects (diarrhea, nausea) are common. Taking with food may help mitigate these.
- Cross-reactivity with penicillin allergy is low (approximately 1-5%), but caution is advised in patients with a history of severe penicillin allergy.
Alternative Therapies
- Other second-generation cephalosporins (e.g., Cefaclor, Cefuroxime axetil)
- Macrolides (e.g., Azithromycin, Clarithromycin) for respiratory infections, especially in penicillin-allergic patients.
- Amoxicillin/Clavulanate (Augmentin) for broader spectrum coverage, particularly for beta-lactamase producing strains.
- Penicillins (e.g., Amoxicillin, Penicillin V) for susceptible infections.
- Other antibiotic classes depending on the specific pathogen and infection site (e.g., fluoroquinolones, tetracyclines).
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 50ml bottle of 125mg/5ml suspension
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations on most commercial and Medicare Part D plans.
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.