Cefzil 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
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, sinus infections, throat infections (strep throat), and skin infections. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to ensure the infection is completely cleared and to prevent antibiotic resistance.
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, measure the liquid carefully 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, measure the liquid carefully 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.
- Cefprozil can be taken with or without food.
- Complete the entire course of medication as prescribed by your doctor, even if symptoms improve.
- Do not save unused medication for future infections.
- Store the oral suspension in the refrigerator (2-8°C or 36-46°F) and discard any unused portion after 14 days.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by infection type and severity. Common doses include 250-500 mg every 12 hours or 500 mg every 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 or 500 mg every 24 hours for 10 days
Skin and Skin Structure Infections:
250 mg every 12 hours or 500 mg every 24 hours for 10 days
Acute Bronchitis (secondary bacterial infection):
500 mg every 12 hours for 10 days
Pediatric Dosing
Neonatal:
Not established (generally not recommended for neonates < 6 months)
Infant:
For infants 6 months to 2 years: Otitis Media: 15 mg/kg every 12 hours for 10 days. Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours for 10 days.
Child:
For children 2 to 12 years: Otitis Media: 15 mg/kg every 12 hours for 10 days. Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours for 10 days. Acute Bacterial Sinusitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours for 10 days. Skin and Skin Structure Infections: 20 mg/kg every 24 hours for 10 days. Max dose 1g/day.
Adolescent:
For adolescents > 12 years: Adult dosing applies.
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 hemodialysis session
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 90%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be slightly delayed (0.25-0.75 hours).
Distribution:
Vd:
Approximately 0.21 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited (does not achieve therapeutically relevant concentrations in CSF)
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Approximately 2.6 mL/min/kg
ExcretionRoute:
Renal (primarily glomerular filtration and tubular secretion)
Unchanged:
Approximately 60% of dose excreted unchanged in urine within 24 hours
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Correlates with peak plasma concentrations (Tmax ~1.5 hours)
DurationOfAction:
Dependent on time above MIC (T>MIC), typically allows for 12-24 hour dosing intervals.
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 accompanied by stomach pain or cramps. Although diarrhea is a common side effect of antibiotics, a rare but serious condition called Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they 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. Your doctor can provide medical advice on managing side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 accompanied by stomach pain or cramps. Although diarrhea is a common side effect of antibiotics, a rare but serious condition called Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they 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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. Seek immediate medical attention.
- Severe, watery diarrhea, or bloody stools, with or without stomach cramps and fever. This could be a sign of a serious intestinal infection (Clostridioides difficile-associated diarrhea) and may occur up to several months after stopping the medication. Contact your doctor immediately.
- New signs of infection (e.g., white patches in the mouth, vaginal itching or discharge) which may indicate a superinfection.
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) drugs, 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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust 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) drugs, 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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust 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 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 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 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 severe cases, neurological effects like seizures (especially in patients with renal impairment)
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is primarily supportive. Hemodialysis may be useful in removing cefprozil from the body, especially in patients with impaired renal function.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., Typhoid vaccine, live): Cefprozil may decrease the therapeutic effect of live bacterial vaccines. Administer vaccine at least 14 days after antibiotic discontinuation.
Moderate Interactions
- Probenecid: May increase and prolong serum concentrations of cefprozil by decreasing renal tubular secretion.
- Oral anticoagulants (e.g., Warfarin): Cephalosporins may rarely enhance the anticoagulant effect of oral anticoagulants, leading to increased INR/bleeding risk. Monitor INR closely.
- Aminoglycosides: Concurrent use with cephalosporins may increase the risk of nephrotoxicity, especially in patients with pre-existing renal impairment (though less common with cefprozil than some other cephalosporins).
Minor Interactions
- Oral contraceptives: Some antibiotics may theoretically reduce the efficacy of oral contraceptives, though evidence is limited for cefprozil. Advise backup contraception if concerned.
Monitoring
Baseline Monitoring
Renal function (CrCl, BUN, Creatinine)
Rationale: To determine appropriate dosing, especially in patients with suspected or known renal impairment, as cefprozil is primarily renally eliminated.
Timing: Prior to initiation of therapy in patients with renal impairment or risk factors for renal dysfunction.
Allergy history (especially to penicillins or other cephalosporins)
Rationale: To assess risk of hypersensitivity reactions due to potential cross-reactivity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection, new onset diarrhea)
Frequency: Daily during therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: If superinfection suspected, discontinue cefprozil and initiate appropriate therapy.
Bowel habits (for Clostridioides difficile-associated diarrhea)
Frequency: Daily during therapy and for several weeks post-therapy
Target: Normal bowel habits
Action Threshold: If severe, persistent diarrhea occurs, consider C. difficile infection and initiate appropriate management.
Signs of allergic reaction (e.g., rash, itching, hives, swelling, difficulty breathing)
Frequency: Daily during therapy
Target: Absence of allergic symptoms
Action Threshold: Discontinue immediately and seek emergency medical attention if severe reaction occurs.
Symptom Monitoring
- Rash
- Hives
- Itching
- Swelling (face, lips, tongue, throat)
- Difficulty breathing or swallowing
- Severe diarrhea (especially watery or bloody)
- Abdominal pain or cramping
- Fever
- New or worsening signs of infection (e.g., white patches in mouth, vaginal itching/discharge)
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women, but based on animal data and clinical experience with similar drugs, it is generally considered safe for use during pregnancy when 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. The amount ingested by a breastfed infant is generally considered to be clinically insignificant. It is rated L2 (Likely Compatible) by Hale's lactation risk categories. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk. Potential for alteration of bowel flora, diarrhea, or sensitization in the infant. Candidiasis (thrush, diaper rash) is also a possibility.
Pediatric Use
Cefprozil oral suspension is approved for use in pediatric patients 6 months of age and older. Dosing is weight-based. 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. Dose adjustment is necessary for elderly patients with significant renal impairment.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens, including Haemophilus influenzae and Moraxella catarrhalis, in addition to Streptococcus pneumoniae.
- It is a good option for pediatric ear infections (otitis media) and strep throat, especially when penicillin allergy is present (unless severe, immediate hypersensitivity reaction to penicillin).
- The oral suspension must be refrigerated and discarded after 14 days.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and ensure eradication of the infection.
- Be vigilant for signs of Clostridioides difficile-associated diarrhea (CDAD), which can occur during or even several weeks after antibiotic therapy.
Alternative Therapies
- Amoxicillin
- Amoxicillin/clavulanate (Augmentin)
- Cefdinir
- Cefuroxime
- Cephalexin
- Azithromycin (for atypical pathogens or penicillin allergy)
- Clindamycin (for skin infections, certain anaerobic infections)
Cost & Coverage
Average Cost:
Varies, typically low to moderate for generic suspension per 75ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.