Cefzil 250mg/5ml Susp 100ml
It is used to treat bacterial infections.
Drug Class
Anti-infective
Pharmacologic Class
Second-generation Cephalosporin Antibiotic
Pregnancy Category
Category B
FDA Approved
Oct 1991
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 (strep throat), and skin infections. It works by killing the bacteria that cause these infections.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your 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. 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 the ingredients are mixed properly. Measure the liquid dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication in the refrigerator to maintain its potency. Discard any unused portion after 2 weeks. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your 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. 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 the ingredients are mixed properly. Measure the liquid dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication in the refrigerator to maintain its potency. Discard any unused portion after 2 weeks. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss 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, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to the infection coming back or the bacteria becoming resistant to the antibiotic.
- Shake the oral suspension well before each use.
- Measure the liquid medication accurately using the provided measuring spoon or cup, not a household spoon.
- Cefprozil 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 your medication with others, even if they have similar symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by infection type and severity. Common doses include 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)
Acute Bronchitis (secondary bacterial infection):
500 mg every 12 hours for 10 days
Uncomplicated 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:
6 months to 12 years: Dosing is weight-based.
Child:
6 months to 12 years:
- Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours for 10 days (max 500 mg/dose)
- Otitis Media: 15 mg/kg every 12 hours for 10 days (max 1000 mg/dose)
- Acute Sinusitis: 7.5 mg/kg every 12 hours for 10 days (mild/moderate) or 15 mg/kg every 12 hours for 10 days (moderate/severe) (max 1000 mg/dose)
- Uncomplicated Skin and Skin Structure Infections (2-12 years): 20 mg/kg every 24 hours for 10 days (max 500 mg/dose)
Adolescent:
Generally, adult dosing applies for adolescents weighing > 45 kg or 12 years and older.
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 after dialysis session on dialysis days. Reduce 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, which interferes with the transpeptidation step of peptidoglycan synthesis, leading to cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 hours (oral suspension)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be slightly delayed and Cmax slightly reduced.
Distribution:
Vd:
0.23 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.3 hours (in subjects with normal renal function)
Clearance:
Renal clearance is the primary route of elimination.
ExcretionRoute:
Renal (primarily unchanged drug)
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:
Sustained antibacterial activity for 12-24 hours, depending on dosing frequency and pathogen susceptibility.
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 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, don't hesitate to reach out to 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 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, don't hesitate to reach out to 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:
- Signs of a severe allergic reaction: rash, hives, itching, swelling (especially of the face, lips, tongue, or throat), severe dizziness, trouble breathing.
- Severe or watery diarrhea, or diarrhea that contains blood or mucus (may occur during or up to several months after treatment).
- Unusual bruising or bleeding.
- Yellowing of the skin or eyes (jaundice).
- Signs of a new infection (e.g., fever, sore throat, vaginal yeast infection, oral thrush).
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.
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
Natural products and vitamins you are using
* Any health problems you have
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, 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
Natural products and vitamins you are using
* Any health problems you have
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, 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 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 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 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:
In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is primarily supportive and symptomatic. Hemodialysis may be useful in removing cefprozil from the body.
Drug Interactions
Moderate Interactions
- Probenecid
- Oral anticoagulants (e.g., Warfarin)
- Aminoglycosides
- Loop diuretics
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, BUN, CrCl)
Rationale: Cefprozil is primarily renally excreted; baseline assessment is crucial, especially in patients with pre-existing renal impairment.
Timing: Prior to initiating therapy, particularly in elderly patients or those with known renal dysfunction.
Routine Monitoring
Clinical response to therapy (resolution of infection symptoms)
Frequency: Daily
Target: Improvement in fever, pain, inflammation, etc.
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistant organism, or alternative diagnosis.
Signs of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)
Frequency: Throughout therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: Development of new symptoms requires evaluation and appropriate treatment.
Renal function (Serum Creatinine, BUN)
Frequency: Periodically, especially during prolonged therapy or in patients with renal impairment
Target: Within normal limits or stable for patient's baseline
Action Threshold: Significant increase may require dose adjustment or discontinuation.
Complete Blood Count (CBC) with differential
Frequency: Periodically, especially during prolonged therapy (>10 days)
Target: Within normal limits
Action Threshold: Significant changes (e.g., eosinophilia, leukopenia, thrombocytopenia) may indicate drug-related adverse effects.
Symptom Monitoring
- Resolution of fever
- Decrease in pain or inflammation at infection site
- Improvement in general well-being
- Development of rash or hives (signs of allergic reaction)
- Onset of severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
- Nausea or vomiting
- Headache
- Dizziness
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of major birth defects.
Second Trimester:
No evidence of increased risk.
Third Trimester:
No evidence of increased 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 generally considered compatible with breastfeeding.
Infant Risk:
Low risk. Potential for alteration of bowel flora, diarrhea, or sensitization in the infant. Monitor for rash or diarrhea in the infant.
Pediatric Use
Cefprozil oral suspension is approved for use in pediatric patients 6 months of age and older. Dosing is weight-based and specific for different types of infections. Safety and effectiveness 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. Dosage adjustment is primarily based on renal function, which may be diminished in elderly patients. Monitor renal function.
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.
- It is generally well-tolerated, with gastrointestinal disturbances (diarrhea, nausea, vomiting) and rash being the most common side effects.
- Ensure patients complete the full course of therapy to prevent bacterial resistance and recurrence of infection.
- The oral suspension must be refrigerated after reconstitution and discarded after 14 days.
- Patients should be advised to report any signs of severe diarrhea, as it could indicate Clostridioides difficile-associated diarrhea (CDAD), which can occur even several weeks after antibiotic discontinuation.
Alternative Therapies
- Other second-generation cephalosporins (e.g., Cefaclor, Cefuroxime axetil)
- Other beta-lactam antibiotics (e.g., Amoxicillin, Amoxicillin/clavulanate)
- Macrolide antibiotics (e.g., Azithromycin, Clarithromycin) for certain infections or in penicillin-allergic patients
- Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for specific indications, though generally reserved for more severe or resistant infections due to broader spectrum and potential side effects.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 100ml bottle of 250mg/5ml suspension
Generic Available:
Yes
Insurance Coverage:
Typically Tier 1 or Tier 2 for generic formulations; Tier 3 or higher for brand-name if available.
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 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 medication taken, the amount, and the time it happened.