Cefzil 125mg/5ml Susp 100ml
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, throat infections (strep throat), sinus infections, 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 to maintain its effectiveness. 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 to maintain its effectiveness. 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
- Take the medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better.
- 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. If it causes stomach upset, taking it with food may help.
- Store the oral suspension in the refrigerator after reconstitution and discard any unused portion after 14 days.
- Avoid alcohol consumption as it may worsen gastrointestinal side effects, though no direct interaction is noted.
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 to moderate); 500 mg every 12 hours for 10 days (severe)
Acute Bacterial Exacerbation of Chronic Bronchitis:
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:
Not established for infants under 6 months.
Child:
6 months to 12 years: Otitis Media: 15 mg/kg every 12 hours for 10 days (max 1g/day); Pharyngitis/Tonsillitis: 7.5 mg/kg every 12 hours or 20 mg/kg every 24 hours for 10 days (max 1g/day); Acute Bacterial Sinusitis: 7.5-15 mg/kg every 12 hours for 10 days (max 1g/day); Uncomplicated Skin/Skin Structure: 20 mg/kg every 24 hours for 10 days (max 1g/day).
Adolescent:
13 years and older: 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 dose by 50% (CrCl < 30 mL/min)
Dialysis:
Administer after dialysis session on dialysis days. Half-life is shortened during hemodialysis.
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 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 95%
Tmax:
1.5 hours
FoodEffect:
Food does not significantly affect the extent of absorption, but peak plasma concentrations may be delayed by 30-60 minutes.
Distribution:
Vd:
Approximately 0.23 L/kg
ProteinBinding:
35-45%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
60-65%
Pharmacodynamics
OnsetOfAction:
Rapid
PeakEffect:
Within 1.5 hours (plasma concentration)
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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, particularly if it is severe, bloody, or accompanied by stomach pain or cramps. Note that diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 and guidance on managing side effects.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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, particularly if it is severe, bloody, or accompanied by stomach pain or cramps. Note that diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, severe dizziness
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Unusual tiredness or weakness
- New or worsening fever, chills, or body aches (may indicate a new infection or superinfection)
- Vaginal itching or discharge, or white patches in the mouth (signs of yeast infection)
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 this 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 to confirm that it is safe to take this medication in conjunction with them. 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.
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 this 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 to confirm that it is safe to take this medication in conjunction with them. 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. 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 exceed the prescribed duration of treatment, 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 exercise caution when taking this medication, 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 this medication to both 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 exceed the prescribed duration of treatment, 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 exercise caution when taking this medication, 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- In rare cases, 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 in the US). 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
- Live bacterial vaccines (e.g., Typhoid vaccine, live): Cefprozil may decrease the therapeutic effect of live bacterial vaccines. Administer at least 24 hours apart.
Moderate Interactions
- Probenecid: May increase cefprozil plasma concentrations and prolong its half-life by decreasing renal tubular secretion.
- Oral anticoagulants (e.g., Warfarin): May rarely enhance the anticoagulant effect, leading to increased INR. Monitor INR closely.
- Aminoglycosides: Although less common with cephalosporins than penicillins, concurrent use may increase the risk of nephrotoxicity, especially in patients with pre-existing renal impairment.
Minor Interactions
- Loop diuretics (e.g., Furosemide): May increase cefprozil levels, though clinical significance is usually minimal.
Monitoring
Baseline Monitoring
Culture and Sensitivity
Rationale: To identify the causative pathogen and confirm its susceptibility to cefprozil, guiding appropriate therapy.
Timing: Prior to initiation of therapy
Renal function (CrCl, BUN, Creatinine)
Rationale: To establish baseline kidney function, as cefprozil is primarily renally eliminated and dose adjustment is required in severe renal impairment.
Timing: Prior to initiation of therapy, especially in patients with suspected or known renal impairment
Routine Monitoring
Clinical response to therapy (e.g., resolution of fever, reduction in symptoms)
Frequency: Daily during acute phase, then periodically until completion of therapy
Target: Improvement in symptoms and signs of infection
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistant organism, or superinfection; consider re-evaluation and alternative therapy.
Signs of superinfection (e.g., new onset diarrhea, oral thrush, vaginal candidiasis)
Frequency: Daily throughout therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: Presence of new symptoms warrants investigation and appropriate treatment (e.g., C. difficile infection).
Complete Blood Count (CBC) with differential
Frequency: Periodically, especially during prolonged therapy or in patients prone to hematologic abnormalities
Target: Within normal limits
Action Threshold: Significant changes (e.g., eosinophilia, leukopenia) may indicate drug-related adverse effects.
Liver function tests (ALT, AST, ALP, Bilirubin)
Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing hepatic impairment
Target: Within normal limits
Action Threshold: Significant elevations may indicate drug-induced hepatotoxicity.
Symptom Monitoring
- Diarrhea (especially severe or persistent, which could indicate C. difficile infection)
- Rash or hives (signs of allergic reaction)
- Difficulty breathing or swallowing (signs of severe allergic reaction)
- Nausea or vomiting
- Abdominal pain
- Headache
- Dizziness
- Vaginal itching or discharge (signs of yeast infection)
- Oral thrush (white patches in mouth)
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. While there are no adequate and well-controlled studies in pregnant women, 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 generally considered compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk (L2 - Safer drug)
Pediatric Use
Cefprozil oral suspension is commonly used in pediatric patients for various infections, including otitis media, pharyngitis/tonsillitis, and skin infections. Dosing is weight-based and specific for different age groups and indications. Safety and efficacy have not been established in infants younger than 6 months of age.
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 (CrCl < 30 mL/min). Monitor renal function.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin with good activity against common respiratory pathogens, including *Streptococcus pneumoniae*, *Haemophilus influenzae*, and *Moraxella catarrhalis*.
- It is a common choice for pediatric otitis media and pharyngitis/tonsillitis due to its convenient dosing (once or twice daily) and palatable suspension formulation.
- Patients should be advised to complete the entire course of therapy to prevent the development of antibiotic resistance and ensure complete eradication of the infection.
- Diarrhea is a common side effect; advise patients to report severe or persistent diarrhea, as it could indicate *Clostridioides difficile*-associated diarrhea (CDAD).
- Refrigeration is required for the reconstituted oral suspension, and it must be discarded after 14 days.
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
- Third-generation cephalosporins (e.g., Cefdinir, Cefixime) for broader spectrum or specific indications
- Penicillins (e.g., Amoxicillin, Amoxicillin/Clavulanate) for susceptible infections
- Macrolides (e.g., Azithromycin, Clarithromycin) for patients with penicillin/cephalosporin allergies or atypical pathogens
- Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for specific indications, generally reserved due to side effect profile
Cost & Coverage
Average Cost:
Not available (varies widely by pharmacy, location, and insurance) per 100ml suspension
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations, Tier 3 for brand-name Cefzil, depending on insurance plan formulary.
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets; consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, do not 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.