Cefprozil 250mg/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 medicine used to treat bacterial infections like ear infections, sinus infections, throat infections, and skin infections. It works by killing the bacteria that cause these infections. It's important to take all of the medicine exactly as prescribed, even if you start feeling better, to make sure the infection is completely cleared and to prevent bacteria from becoming resistant.
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 and discard any unused portion after 2 weeks. Do not freeze the medication. Keep all medications in a safe place, 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 and discard any unused portion after 2 weeks. Do not freeze the medication. Keep all medications in a safe place, 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 full course of medication as prescribed, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Shake the oral suspension well before each use.
- Use an accurate measuring device (e.g., oral syringe or measuring spoon) to ensure correct dosing.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Maintain good hydration, especially if experiencing diarrhea.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., Pharyngitis/Tonsillitis: 500 mg every 24 hours; Sinusitis: 250-500 mg every 12 hours; Skin/Skin Structure: 250-500 mg every 12-24 hours.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg every 24 hours 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)
Skin and Skin Structure Infections:
250 mg every 12 hours or 500 mg every 24 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 6 months.
Child:
Otitis Media: 15 mg/kg every 12 hours for 10 days (6 months to 12 years, max 1g/day); Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours for 10 days (6 months to 12 years, max 1g/day); Acute Bacterial Sinusitis: 7.5 mg/kg every 12 hours or 15 mg/kg every 12 hours for 10 days (6 months to 12 years, max 1g/day).
Adolescent:
Dosing typically follows adult recommendations for adolescents weighing > 45 kg or over 12 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 30 mL/min)
Moderate:
50% of standard dose (CrCl 0-29 mL/min)
Severe:
50% of standard dose (CrCl 0-29 mL/min)
Dialysis:
Administer after dialysis session on dialysis days. 50% of standard dose.
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 disruption of the cell wall, resulting in cell lysis and bacterial death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food may delay Tmax by 0.5-1 hour and decrease Cmax by 25%, but the extent of absorption (AUC) is unaffected.
Distribution:
Vd:
Approximately 0.23 L/kg
ProteinBinding:
Approximately 35%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Not available (primarily renal)
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
Approximately 60% (within 24 hours)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Within 1.5 hours (plasma concentration)
DurationOfAction:
Dependent on dosing frequency (e.g., 12-24 hours for effect)
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 watery, or if you experience 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 all 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 watery, or if you experience 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 all 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 or watery diarrhea, especially if it contains blood or mucus, or is accompanied by fever and abdominal cramps (may indicate C. difficile infection).
- Signs of an 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.
- Persistent nausea or vomiting.
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 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change 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, 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 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change 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, as this medication may affect the accuracy of certain tests. Additionally, be sure to inform 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 a second 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 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 inform 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 a second 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 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:
Call 1-800-222-1222 (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 in cases of severe overdose with renal impairment.
Drug Interactions
Major Interactions
- Probenecid (increases cefprozil levels)
- Oral anticoagulants (e.g., Warfarin - potential for increased INR/bleeding risk)
Moderate Interactions
- Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins than with other beta-lactams)
- Loop diuretics (e.g., Furosemide - potential for increased nephrotoxicity, especially in patients with pre-existing renal impairment)
Minor Interactions
- Typhoid vaccine (live, oral) - antibiotics may reduce therapeutic effect of vaccine
Monitoring
Baseline Monitoring
Culture and Sensitivity
Rationale: To identify the causative pathogen and confirm susceptibility to cefprozil, guiding appropriate antibiotic therapy.
Timing: Prior to initiation of therapy
Renal Function (CrCl, BUN, Creatinine)
Rationale: Cefprozil is primarily renally eliminated; baseline assessment is crucial for dose adjustment in patients with impaired renal function.
Timing: Prior to initiation of therapy, especially in elderly or those with suspected renal impairment
Routine Monitoring
Signs and Symptoms of Infection
Frequency: Daily
Target: Resolution of fever, pain, inflammation, and other infection-specific symptoms
Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate treatment failure, resistance, or alternative diagnosis.
Bowel Habits
Frequency: Daily
Target: Normal bowel movements
Action Threshold: Development of severe, persistent diarrhea, especially with fever or abdominal cramps, may indicate Clostridioides difficile-associated diarrhea (CDAD).
Skin for Rash/Allergic Reaction
Frequency: Daily
Target: Absence of rash, urticaria, pruritus, or other signs of hypersensitivity
Action Threshold: Appearance of rash, hives, or signs of anaphylaxis requires immediate discontinuation.
INR (if on Warfarin)
Frequency: Regularly, as per standard Warfarin monitoring, with increased vigilance during and after cefprozil therapy.
Target: Therapeutic range for indication
Action Threshold: Significant increase in INR outside target range requires Warfarin dose adjustment.
Symptom Monitoring
- Diarrhea (especially severe or bloody)
- Nausea
- Vomiting
- Abdominal pain
- Rash
- Hives
- Itching
- Difficulty breathing or swallowing (signs of allergic reaction)
- Dizziness
- Headache
- Vaginal itching or discharge (yeast infection)
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 no increased risk of birth defects or other adverse outcomes. It is generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, no evidence of teratogenicity from animal studies.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Cefprozil is excreted in human milk in very low concentrations. The amount ingested by a breastfed infant is generally considered to be clinically insignificant. It is rated L2 (likely compatible). Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (e.g., rash).
Infant Risk:
Low risk. Potential for alteration of gut flora, leading to diarrhea or candidiasis; theoretical risk of allergic sensitization.
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. Close monitoring for adverse effects, particularly gastrointestinal disturbances, is recommended.
Geriatric Use
No overall differences in safety or effectiveness have been 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 impaired renal function, as cefprozil is primarily renally eliminated.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens (e.g., S. pneumoniae, H. influenzae, M. catarrhalis) and skin pathogens (e.g., S. aureus, S. pyogenes).
- It is a good option for community-acquired respiratory tract infections and uncomplicated skin and skin structure infections.
- Unlike some other cephalosporins, cefprozil is generally well-tolerated with a low incidence of adverse effects.
- Patients should be advised to complete the entire course of therapy to prevent the development of antibiotic resistance.
- The oral suspension must be shaken well before each use and refrigerated after reconstitution.
Alternative Therapies
- Amoxicillin
- Amoxicillin/Clavulanate
- Cefdinir
- Cefuroxime
- Cephalexin
- Azithromycin
- Clarithromycin
- Doxycycline
Cost & Coverage
Average Cost:
Check current market data per 50ml suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.