Cefzil 250mg/5ml Susp 50ml
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Cephalosporin (Second Generation)
Pregnancy Category
Category B
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefprozil is an antibiotic used to treat various bacterial infections, such as ear infections, sinus infections, throat infections, and skin infections. It works by killing the bacteria that cause these infections.
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.
What to Do If You Miss 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.
What to Do If You Miss 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
- 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 antibiotic resistance and recurrence of infection.
- Cefprozil oral suspension can be taken with or without food. Shake the suspension well before each use.
- Use an accurate measuring spoon or cup for the liquid form, not a household spoon.
- Store the oral suspension in the refrigerator after reconstitution and discard any unused portion after 14 days.
- Avoid alcohol consumption while taking antibiotics, as it may worsen side effects like nausea or dizziness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by infection type and severity. Common doses include 250 mg or 500 mg every 12 or 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 to moderate) or 500 mg every 12 hours for 10 days (moderate to severe)
Acute Bronchitis:
500 mg every 12 hours for 10 days
Skin and Skin Structure Infections (uncomplicated):
250 mg every 12 hours or 500 mg every 24 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
6 months to 2 years: 7.5 mg/kg every 12 hours for 10 days (e.g., otitis media, pharyngitis/tonsillitis)
Child:
2 to 12 years: 15 mg/kg every 12 hours for 10 days (e.g., otitis media, sinusitis); 7.5 mg/kg every 12 hours for 10 days (e.g., pharyngitis/tonsillitis)
Adolescent:
13 years and older: Adult dosing applies (e.g., 250-500 mg every 12-24 hours)
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 on dialysis days. Reduce total daily dose by 50%.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Cefprozil is a second-generation cephalosporin antibiotic. It exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. It binds to one or more of the penicillin-binding proteins (PBPs) located on the bacterial cell wall, thereby interfering with the final transpeptidation step of peptidoglycan synthesis. This inhibition leads to the disruption of the cell wall, resulting in bacterial cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be slightly delayed (0.25 to 0.75 hours) and Cmax may be slightly reduced (10-15%). Can be taken with or without food.
Distribution:
Vd:
Approximately 0.21 L/kg
ProteinBinding:
30-40%
CnssPenetration:
Limited (does not achieve therapeutically relevant concentrations in CSF)
Elimination:
HalfLife:
1.0 to 1.4 hours
Clearance:
Approximately 2.6 mL/min/kg
ExcretionRoute:
Primarily renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 60-65% of the administered dose is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Correlates with peak plasma concentrations (Tmax)
DurationOfAction:
Maintained for 12-24 hours, supporting twice or once daily dosing
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. 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 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
Important Notes
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
For medical advice about side effects, contact your doctor.
To report side effects, you can call the FDA at 1-800-332-1088 or visit their website 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 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 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
Important Notes
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
For medical advice about side effects, contact your doctor.
To report side effects, you can call the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe diarrhea (watery or bloody stools), especially if it occurs weeks after stopping the medication, as this could be a sign of 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.
- Severe abdominal pain.
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.
To ensure your safety, it is crucial to verify that it is safe to take this medication in combination with all your other medications and health conditions. Never start, stop, or adjust the dose 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.
To ensure your safety, it is crucial to verify that it is safe to take this medication in combination with all your other medications and health conditions. Never start, stop, or adjust the dose 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 certain 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.
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 certain 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.
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
- Hypersensitivity reactions (e.g., rash, itching)
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 and symptomatic. Hemodialysis may be useful in removing cefprozil from the body.
Drug Interactions
Moderate Interactions
- Probenecid
- Aminoglycosides
- Oral Anticoagulants (e.g., Warfarin)
Minor Interactions
- Loop Diuretics
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: To establish baseline for patients with pre-existing renal impairment or those at risk, as cefprozil is primarily renally eliminated.
Timing: Prior to initiation of therapy, especially in elderly or renally impaired patients.
Allergy history
Rationale: To identify potential hypersensitivity reactions, especially to penicillins or other cephalosporins.
Timing: Before administering the first dose.
Routine Monitoring
Signs and symptoms of infection resolution
Frequency: Daily
Target: Improvement in fever, pain, inflammation, etc.
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism; consider culture and sensitivity testing.
Signs and symptoms of adverse reactions (e.g., diarrhea, rash, nausea, vomiting)
Frequency: Daily
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or persistent diarrhea (especially watery/bloody) may indicate C. difficile infection; severe rash or signs of hypersensitivity require immediate discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically, especially with prolonged therapy or in patients with pre-existing renal impairment or concurrent nephrotoxic drugs.
Target: Within normal limits or stable for patient's baseline
Action Threshold: Significant increase may require dose adjustment or discontinuation.
INR (International Normalized Ratio)
Frequency: More frequently if co-administered with oral anticoagulants (e.g., warfarin).
Target: Within therapeutic range for indication
Action Threshold: INR outside target range requires anticoagulant dose adjustment.
Symptom Monitoring
- Diarrhea (especially severe, watery, or bloody)
- Skin rash or hives
- Itching
- Difficulty breathing or swallowing
- Swelling of face, lips, tongue, or throat
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Dizziness
- 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 do not suggest an increased risk of major birth defects or miscarriage. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and limited human experience.
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 generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk (L2 - Safer)
Pediatric Use
Cefprozil is widely used and generally well-tolerated in pediatric patients aged 6 months and older for approved 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. Dosage adjustment is necessary in elderly patients with significant renal impairment, as cefprozil is primarily renally eliminated. Monitor renal function.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin effective against a broad range of Gram-positive and some Gram-negative bacteria, making it useful for common respiratory, skin, and ear infections.
- The oral suspension must be refrigerated after reconstitution and discarded after 14 days.
- Counsel patients to complete the full course of therapy to prevent antibiotic resistance and ensure complete eradication of the infection.
- While generally well-tolerated, gastrointestinal side effects (diarrhea, nausea, vomiting) are common. Advise patients to report severe or persistent diarrhea.
- Cross-reactivity with penicillin allergy is low (approximately 1-5%), but caution is advised in patients with a history of severe penicillin allergy.
Alternative Therapies
- Amoxicillin
- Amoxicillin/Clavulanate
- Azithromycin
- Clarithromycin
- Cefdinir
- Cefuroxime
- Levofloxacin (for specific indications and age groups)
- Doxycycline (for specific indications and age groups)
Cost & Coverage
Average Cost:
Varies, typically $30-$100 per 50ml suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (brand)
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 happened.