Cefprozil 125mg/5ml Susp 100ml
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Cephalosporin, Second Generation
Pregnancy Category
Category B
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefprozil is an antibiotic medicine used to treat various bacterial infections, such as ear infections, sinus infections, throat 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 feeling well. You can take this medication with or without food, but if it causes stomach upset, take it with food.
Before using the liquid form, 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 the 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'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.
Before using the liquid form, 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 the 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'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 medicine exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early.
- Shake the oral suspension well before each use.
- Measure the liquid medicine carefully using the provided measuring spoon or cup, not a household spoon.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Do not share your medicine with others.
- If you experience severe or watery diarrhea, especially with fever or abdominal cramps, contact your doctor immediately 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 every 12-24 hours depending on infection type and severity
Dose Range:
250 - 500 mg
Condition-Specific Dosing:
pharyngitis_tonsillitis:
500 mg once daily
acute_bacterial_sinusitis:
250 mg every 12 hours or 500 mg once daily
acute_bronchitis:
500 mg every 12 hours
skin_skin_structure_infections:
250 mg every 12 hours or 500 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
6 months to 12 years: 7.5 mg/kg every 12 hours for otitis media, 15 mg/kg every 12 hours for pharyngitis/tonsillitis or skin/skin structure infections. Max 500 mg/dose.
Child:
6 months to 12 years: 7.5 mg/kg every 12 hours for otitis media, 15 mg/kg every 12 hours for pharyngitis/tonsillitis or skin/skin structure infections. Max 500 mg/dose.
Adolescent:
Typically adult dosing (e.g., 500 mg once daily or 250-500 mg every 12 hours) if weight/age appropriate.
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 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 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:
95%
Tmax:
1.5 hours
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be delayed by 30-60 minutes.
Distribution:
Vd:
0.23 L/kg
ProteinBinding:
36%
CnssPenetration:
Limited
Elimination:
HalfLife:
1.3 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
60-65%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for symptomatic relief)
PeakEffect:
1.5 hours (plasma concentration)
DurationOfAction:
12-24 hours (based on dosing interval)
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. 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. 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
Reporting Side Effects
This list is not exhaustive, and you may experience other 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. 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. 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
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 or watery diarrhea
- Abdominal pain or cramps
- Rash, hives, itching
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Wheezing
- Yellowing of the skin or eyes (jaundice)
- Unusual bruising or bleeding
- 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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.
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, seizures (especially in patients with renal impairment)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive; hemodialysis may be useful in removing cefprozil from the body.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., Typhoid vaccine, live)
Moderate Interactions
- Probenecid
- Oral anticoagulants (e.g., Warfarin)
- Aminoglycosides (e.g., Gentamicin, Tobramycin)
Monitoring
Baseline Monitoring
Culture and Sensitivity
Rationale: To identify causative pathogen and confirm susceptibility to cefprozil.
Timing: Prior to initiation of therapy
Renal function (BUN, Creatinine)
Rationale: To establish baseline for patients with pre-existing renal impairment or those at risk, as cefprozil is primarily renally eliminated.
Timing: Prior to initiation of therapy, especially in elderly or renally impaired patients
Routine Monitoring
Clinical response (symptom resolution)
Frequency: Daily
Target: Improvement in signs and symptoms of infection
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.
Signs of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)
Frequency: Daily
Target: Absence of new infections
Action Threshold: Development of new symptoms; consider discontinuing cefprozil and initiating appropriate therapy.
Renal function (BUN, Creatinine)
Frequency: Periodically, as clinically indicated
Target: Within patient's baseline or normal limits
Action Threshold: Significant increase in BUN/Creatinine; consider dose adjustment or alternative therapy.
Symptom Monitoring
- Fever
- Pain
- Inflammation
- Discharge
- Rash
- Diarrhea (especially severe or persistent)
- Signs of allergic reaction (hives, itching, swelling, difficulty breathing)
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 suggest low risk. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, no evidence of increased congenital anomalies.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Cefprozil is excreted in human milk in very low concentrations. The amount ingested by an infant is typically very small. Generally considered compatible with breastfeeding, but monitor infant for potential changes in bowel flora (diarrhea, candidiasis) or allergic reactions.
Infant Risk:
Low risk (L2)
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 necessary for elderly patients with significant renal impairment.
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.
- It is a good option for patients who may have difficulty tolerating penicillin or amoxicillin, provided there is no severe penicillin allergy (e.g., anaphylaxis).
- The oral suspension must be shaken well before each use and refrigerated after reconstitution. Discard after 14 days.
- Counsel patients to complete the full course of therapy to prevent resistance and ensure eradication of infection.
- Be mindful of potential for Clostridioides difficile-associated diarrhea (CDAD) with any antibiotic use; counsel patients on symptoms and when to seek medical attention.
Alternative Therapies
- Amoxicillin
- Amoxicillin/clavulanate
- Cefdinir
- Cefuroxime
- Azithromycin
- Clarithromycin
- Levofloxacin (for specific indications and age groups)
- Doxycycline (for specific indications and age groups)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$60 per 100ml bottle of 125mg/5ml suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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 this 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.