Cefzil 250mg/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 killing the bacteria that cause these infections. 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 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. 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. 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
- Shake the oral suspension well before each use.
- Measure the dose accurately using the provided measuring spoon or cup.
- Can be taken with or without food.
- Complete the entire course of medication as prescribed, even if symptoms improve.
- Do not save leftover medication for future infections.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
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 - 500 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 (safety and efficacy not established in infants less than 6 months of age)
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 for 10 days.
Child:
For children 2-12 years: Otitis Media: 15 mg/kg every 12 hours for 10 days; Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours for 10 days; Acute Bacterial Sinusitis: 7.5-15 mg/kg every 12 hours for 10 days; Skin and Skin Structure Infections: 20 mg/kg every 24 hours for 10 days.
Adolescent:
Typically dosed as adults for most indications, or up to 15 mg/kg/dose for specific infections, not to exceed adult maximum doses.
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 after dialysis sessions on dialysis days. On non-dialysis days, administer the reduced 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. This leads to the disruption of the cell wall, resulting in cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food may delay Tmax by 0.5 to 1 hour and decrease Cmax by 25%, but the extent of absorption (AUC) is generally unaffected.
Distribution:
Vd:
Approximately 0.23 L/kg
ProteinBinding:
35-45%
CnssPenetration:
Limited (does not achieve therapeutically relevant concentrations in CSF)
Elimination:
HalfLife:
1.3 hours
Clearance:
Not readily available as a single rate, primarily renal clearance
ExcretionRoute:
Renal (primarily unchanged in urine)
Unchanged:
Approximately 60-65% of the dose is excreted unchanged in the urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours of first dose
PeakEffect:
Correlates with Cmax, approximately 1.5 hours post-dose
DurationOfAction:
Maintained for 12-24 hours depending on dosing frequency and pathogen susceptibility (Time above MIC is critical for cephalosporins)
Confidence:
High
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 accompanied by 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 several months after taking 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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual 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 accompanied by 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 several months after taking 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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual 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 allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Severe or watery diarrhea, especially if persistent or bloody (may be C. difficile infection)
- New or worsening signs of infection (e.g., fever, sore throat, chills) that could indicate a superinfection
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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.
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 to ensure the best possible outcome 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. 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.
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 to ensure the best possible outcome 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, contact a poison control center immediately (call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is primarily supportive and symptomatic. 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, oral): Antibiotics may reduce the therapeutic effect of live bacterial vaccines. Administer vaccine at least 14 days before or 24 hours after antibiotic.
Moderate Interactions
- Probenecid: May increase and prolong cefprozil serum concentrations by decreasing renal tubular secretion.
- Oral anticoagulants (e.g., Warfarin): May enhance the anticoagulant effect. Monitor INR/PT closely.
- Aminoglycosides: Concurrent use with cephalosporins may increase the risk of nephrotoxicity, though less common with cefprozil than with other cephalosporins.
Monitoring
Baseline Monitoring
Culture and Susceptibility Testing
Rationale: To identify the causative pathogen and confirm its susceptibility to cefprozil, guiding appropriate therapy.
Timing: Prior to initiation of therapy, if clinically indicated.
Renal Function (BUN, Creatinine)
Rationale: To establish baseline kidney function, especially important for patients with pre-existing renal impairment, as cefprozil is primarily renally eliminated.
Timing: Prior to initiation of therapy, particularly in elderly or renally impaired patients.
Routine Monitoring
Clinical Response (resolution of signs/symptoms of infection)
Frequency: Daily during acute phase, then periodically until completion of therapy.
Target: Improvement or resolution of 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 candidiasis, severe diarrhea)
Frequency: Daily throughout therapy and for several weeks post-therapy.
Target: Absence of new infections.
Action Threshold: Development of new symptoms requires evaluation and potential discontinuation of cefprozil.
Renal Function (BUN, Creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic drugs.
Target: Within patient's baseline or acceptable limits.
Action Threshold: Significant increase in BUN/creatinine may necessitate dose adjustment or discontinuation.
Symptom Monitoring
- Rash
- Hives
- Difficulty breathing or swallowing (signs of allergic reaction)
- Severe or watery diarrhea (may indicate C. difficile-associated diarrhea)
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Dizziness
- Vaginal itching or discharge (signs of yeast infection)
- White patches in mouth (signs of oral thrush)
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. Generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in limited human data.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Cefprozil is excreted in low concentrations in human breast milk. The amount ingested by a breastfed infant is generally considered to be low and unlikely to cause significant adverse effects. It is generally considered compatible with breastfeeding.
Infant Risk:
Low risk. Potential for alteration of infant gut flora (leading to diarrhea or candidiasis) or allergic sensitization. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or rash.
Pediatric Use
Safety and efficacy have been established for pediatric patients 6 months to 12 years of age for specific indications. Dosing is weight-based. Not recommended for infants younger than 6 months.
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 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 with good activity against common respiratory pathogens like *Streptococcus pneumoniae*, *Haemophilus influenzae*, and *Moraxella catarrhalis*, as well as skin pathogens like *Staphylococcus aureus* (methicillin-susceptible) and *Streptococcus pyogenes*.
- It is a good option for pediatric otitis media, pharyngitis, and sinusitis due to its palatable suspension formulation and convenient dosing.
- Patients should be advised to shake the suspension well before each use and to store it in the refrigerator.
- Counsel patients on the importance of completing the full course of therapy to prevent antibiotic resistance and ensure complete eradication of the infection.
- While generally well-tolerated, common side effects include diarrhea, nausea, vomiting, and rash.
Alternative Therapies
- Other second-generation cephalosporins (e.g., cefuroxime, cefaclor)
- First-generation cephalosporins (e.g., cephalexin, cefadroxil) for skin/soft tissue infections or uncomplicated UTIs
- Penicillins (e.g., amoxicillin, amoxicillin/clavulanate) for susceptible infections
- Macrolides (e.g., azithromycin, clarithromycin) for patients with penicillin/cephalosporin allergies or atypical pathogens
- Other antibiotic classes depending on the specific infection and susceptibility.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan, typically $20-$100+ per 75ml bottle of 250mg/5ml suspension
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations, Tier 3 for brand-name if available.
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 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.