Cefprozil 125mg/5ml Susp 75ml
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Second-generation cephalosporin
Pregnancy Category
Category B
FDA Approved
Mar 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefprozil is an antibiotic 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. It's important to take the full course of medication as prescribed, even if you start feeling better, to ensure all bacteria are killed and prevent the infection from returning.
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, carefully measure the liquid 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 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. To ensure accurate dosing, carefully measure the liquid 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 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
- Shake the oral suspension well before each use.
- Measure the dose accurately using the provided measuring spoon or cup.
- This medication can be taken with or without food.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Do not share this medication with others.
- Complete the entire course of therapy, even if symptoms improve, to prevent resistance and recurrence.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication, e.g., Pharyngitis/Tonsillitis: 500 mg every 24 hours for 10 days; Acute Bacterial Sinusitis: 250-500 mg every 12 hours for 10 days; Skin and Skin Structure Infections: 250-500 mg every 12-24 hours for 10 days.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg every 24 hours for 10 days
Acute Bacterial Sinusitis:
250-500 mg every 12 hours for 10 days
Acute Bacterial Exacerbation of Chronic Bronchitis:
500 mg every 12 hours for 10 days
Skin and Skin Structure Infections (uncomplicated):
250-500 mg every 12-24 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Otitis Media (6 months to 12 years): 15 mg/kg every 12 hours for 10 days (max 1000 mg/day)
Child:
Pharyngitis/Tonsillitis (2 to 12 years): 7.5 mg/kg every 12 hours for 10 days or 20 mg/kg every 24 hours for 10 days (max 1000 mg/day); Otitis Media (6 months to 12 years): 15 mg/kg every 12 hours for 10 days (max 1000 mg/day); Skin and Skin Structure Infections (2 to 12 years): 20 mg/kg every 24 hours for 10 days (max 1000 mg/day)
Adolescent:
Generally adult dosing applies for adolescents weighing >45 kg or as per pediatric guidelines for younger adolescents.
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 as hemodialysis removes approximately 60% of the drug over 3 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 transpeptidation step of peptidoglycan synthesis, which is crucial for cell wall integrity and rigidity. This leads to the lysis and death of susceptible bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
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:
Approximately 0.23 L/kg
ProteinBinding:
Approximately 35%
CnssPenetration:
Limited (does not achieve therapeutically effective concentrations in CSF unless meninges are inflamed)
Elimination:
HalfLife:
Approximately 1.3 hours (normal renal function)
Clearance:
Approximately 3 mL/min/kg
ExcretionRoute:
Renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 60% excreted unchanged in urine within 24 hours
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours of first dose
PeakEffect:
Within 1.5 hours of administration
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours) and MIC of pathogen
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, which may indicate a serious side effect:
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). CDAD can occur during or several months after taking antibiotics. If you experience any of these symptoms, contact your doctor right away. Before treating diarrhea, consult with your doctor.
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
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, which may indicate a serious side effect:
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). CDAD can occur during or several months after taking antibiotics. If you experience any of these symptoms, contact your doctor right away. Before treating diarrhea, consult with your doctor.
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Severe or watery diarrhea, especially if it contains blood or mucus (may indicate C. difficile infection)
- Unusual bleeding or bruising
- Yellowing of skin or eyes (jaundice)
- Signs of new infection (e.g., fever, sore throat, chills) that develop during or after treatment
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
Any existing health problems or conditions
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or modify 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
Any existing health problems or conditions
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or modify 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 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 take 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.
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 breastfeeding, consult with your doctor to discuss the potential benefits and risks of taking this medication to both 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 take 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.
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 breastfeeding, consult with your doctor to discuss the potential benefits and risks of taking this medication to both 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 overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is primarily supportive. Hemodialysis may be useful in removing the drug from the body.
Drug Interactions
Moderate Interactions
- Probenecid (increases cefprozil plasma concentrations)
- Oral anticoagulants (e.g., warfarin - may increase INR/bleeding risk)
- Live bacterial vaccines (e.g., typhoid vaccine - may reduce efficacy of vaccine)
Minor Interactions
- Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins than penicillins)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate dosing, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy, particularly in elderly or renally impaired patients.
Routine Monitoring
Signs and symptoms of infection resolution
Frequency: Daily
Target: Improvement in fever, pain, inflammation
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 requires evaluation and potential discontinuation/alternative therapy.
INR (International Normalized Ratio)
Frequency: As clinically indicated, especially at initiation and discontinuation of cefprozil, and during therapy
Target: Therapeutic range for patient's condition
Action Threshold: Significant deviation from target range; requires dose adjustment of anticoagulant.
Symptom Monitoring
- Rash
- Hives
- Difficulty breathing or swallowing (signs of allergic reaction)
- Severe diarrhea (especially if bloody or watery, indicative of C. difficile-associated diarrhea)
- Unusual bruising or bleeding (if on anticoagulants)
- New onset of fever or worsening symptoms after initial improvement
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. Use during pregnancy should be considered if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data limited but no clear evidence of harm.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
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 (rash).
Infant Risk:
Low risk (L2 - Safer)
Pediatric Use
Cefprozil is approved for use in pediatric patients 6 months of age and older for specific indications. 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, offering broader coverage than first-generation agents, including activity against some Haemophilus influenzae and Moraxella catarrhalis strains, making it useful for respiratory tract infections.
- 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 bacterial resistance and ensure eradication of the infection.
- While generally well-tolerated, gastrointestinal side effects (diarrhea, nausea, vomiting) are common. Advise patients to report severe or persistent diarrhea.
- Patients with a history of severe allergic reactions to penicillin should be monitored closely due to potential cross-reactivity (though less common with second-generation cephalosporins).
Alternative Therapies
- Amoxicillin
- Amoxicillin/clavulanate
- Azithromycin
- Clarithromycin
- Other cephalosporins (e.g., cefdinir, cefuroxime, cephalexin)
- Penicillin V (for strep throat, if susceptible)
Cost & Coverage
Average Cost:
Check current market data per 75ml 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 for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.