Cefprozil 250mg/5ml Susp 100ml
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, throat infections (strep throat), sinus infections, 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 to help minimize this side effect.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store this medication in the refrigerator at all times. 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 is 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. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store this medication in the refrigerator at all times. 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 is 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, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
- Shake the oral suspension well before each use.
- Use a calibrated measuring spoon or oral syringe for accurate dosing.
- This medication can be taken with or without food.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Avoid alcohol consumption, as it may worsen gastrointestinal side effects, though no direct interaction is known.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg orally every 12 to 24 hours, depending on infection type and severity.
Dose Range:
250 - 500 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg orally once daily for 10 days
Acute Bacterial Exacerbation of Chronic Bronchitis:
500 mg orally every 12 hours for 10 days
Acute Sinusitis:
250 mg orally every 12 hours or 500 mg orally once daily for 10 days
Uncomplicated Skin and Skin Structure Infections:
250 mg orally every 12 hours or 500 mg orally once daily for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 6 months of age.
Child:
6 months to 12 years: Otitis Media: 15 mg/kg orally every 12 hours for 10 days. Pharyngitis/Tonsillitis: 7.5 mg/kg orally every 12 hours for 10 days. Skin/Skin Structure Infections: 20 mg/kg orally once daily for 10 days. Max dose 500 mg/dose.
Adolescent:
13 years and older: Refer to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 30 mL/min)
Moderate:
No adjustment needed (CrCl > 30 mL/min)
Severe:
Reduce total daily dose by 50% (CrCl < 30 mL/min)
Dialysis:
Administer dose after dialysis session on dialysis days. Reduce total daily dose by 50%.
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
FoodEffect:
Food does not affect the extent of absorption, but Tmax is slightly delayed (0.25 to 0.75 hours).
Distribution:
Vd:
Not widely distributed; approximately 0.21 L/kg
ProteinBinding:
Approximately 35%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Approximately 3.7 mL/min/kg
ExcretionRoute:
Renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 60-70%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 1.5 hours (peak plasma concentration)
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours)
Safety & Warnings
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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 may be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Upset stomach
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other 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. Your doctor can provide medical advice about side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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 may be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Upset stomach
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other 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. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection).
- New or worsening fever, chills, or body aches.
- Unusual bruising or bleeding.
- Yellowing of the skin or eyes (jaundice).
- Signs of a 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) medications, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee your safety, it is vital to verify that this medication can be taken safely with all your current medications and health conditions. Always consult your doctor before starting, stopping, or modifying 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) medications, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee your safety, it is vital to verify that this medication can be taken safely with all your current medications and health conditions. Always consult your doctor before starting, stopping, or modifying 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.
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, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with the results of some lab tests.
Do not take this medication for longer than prescribed, as this may increase the risk of developing 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 taking 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 weigh the benefits and risks of taking this medication, both 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 for you, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with the results of some lab tests.
Do not take this medication for longer than prescribed, as this may increase the risk of developing 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 taking 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 weigh the benefits and risks of taking this medication, both 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 overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally 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., BCG, typhoid oral) - may reduce therapeutic effect of vaccine.
Moderate Interactions
- Probenecid - may increase cefprozil concentrations.
- Oral anticoagulants (e.g., Warfarin) - may enhance anticoagulant effect (monitor INR).
- Aminoglycosides - theoretical risk of nephrotoxicity (less common with cephalosporins than penicillins, but caution advised).
Monitoring
Baseline Monitoring
Renal function (CrCl, BUN, creatinine)
Rationale: To determine appropriate dosing, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy
Allergy history (especially to cephalosporins, penicillins, or other beta-lactams)
Rationale: To prevent hypersensitivity reactions.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)
Frequency: Daily during therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: Development of new or worsening symptoms; consider discontinuation and alternative therapy.
Bowel movements (for C. difficile-associated diarrhea)
Frequency: Daily during therapy and for several weeks post-therapy
Target: Normal bowel habits
Action Threshold: Persistent or severe diarrhea; test for C. difficile.
INR (if co-administered with warfarin)
Frequency: As clinically indicated, especially at initiation and discontinuation of cefprozil
Target: Therapeutic INR range for patient's condition
Action Threshold: INR outside target range; adjust warfarin dose.
Symptom Monitoring
- Rash
- Hives
- Itching
- Swelling (face, lips, tongue, throat)
- Difficulty breathing or swallowing
- Severe diarrhea (especially if bloody or watery)
- Abdominal pain or cramping
- Nausea
- Vomiting
- Headache
- Dizziness
- Vaginal itching or discharge
- Oral thrush (white patches in mouth)
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 birth defects or other adverse outcomes. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk; no evidence of teratogenicity in animal studies.
Second Trimester:
Low risk; generally considered safe.
Third Trimester:
Low risk; generally considered safe.
Lactation
Cefprozil is excreted in human milk in very low concentrations. While generally considered compatible with breastfeeding, monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk (L2 - likely compatible)
Pediatric Use
Cefprozil is approved for use in pediatric patients 6 months of age and older. Dosing is weight-based. 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 primarily based on renal function, which may be diminished in elderly patients.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens like S. pneumoniae, H. influenzae, and M. catarrhalis, making it a good choice for otitis media, sinusitis, and pharyngitis.
- It has a relatively long half-life compared to some other oral cephalosporins, allowing for once or twice daily dosing.
- The oral suspension should be shaken well before each use and refrigerated after reconstitution.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and ensure eradication of infection.
- Like other antibiotics, it can cause C. difficile-associated diarrhea; advise patients to seek medical attention for severe or persistent diarrhea.
Alternative Therapies
- Other second-generation cephalosporins (e.g., cefuroxime, cefaclor)
- Third-generation cephalosporins (e.g., cefdinir, cefixime)
- Penicillins (e.g., amoxicillin, amoxicillin/clavulanate)
- Macrolides (e.g., azithromycin, clarithromycin) for specific indications or penicillin-allergic patients
- Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for specific indications
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 100ml of 250mg/5ml suspension
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 this medication, don't hesitate to discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.