Cefzil 250mg Tablets

Manufacturer BRISTOL-MYERS-SQUIBB Active Ingredient Cefprozil Tablets(sef PROE zil) Pronunciation sef PROE zil
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Second-generation cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Oct 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefprozil is an antibiotic medication used to treat various bacterial infections in the body. It works by killing the bacteria that cause these infections, helping you to get better. It's important to take it exactly as prescribed by your doctor.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. 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.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.

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 the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to the infection returning or becoming harder to treat.
  • Cefprozil can be taken with or without food.
  • If you are using the oral suspension, shake the bottle well before each dose.
  • Store the oral suspension in the refrigerator and discard any unused portion after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. E.g., Pharyngitis/Tonsillitis: 500 mg q24h for 10 days; Acute Bacterial Sinusitis: 250 mg q12h or 500 mg q12h for 10 days; Skin and Skin Structure Infections: 250 mg q12h or 500 mg q12h or 500 mg q24h for 10 days.
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis: 500 mg q24h for 10 days
Acute Bacterial Sinusitis: 250 mg q12h or 500 mg q12h for 10 days
Acute Bronchitis (secondary bacterial infection): 500 mg q12h for 10 days
Skin and Skin Structure Infections: 250 mg q12h or 500 mg q12h or 500 mg q24h for 10 days
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Pediatric Dosing

Neonatal: Not established
Infant: For infants >6 months: Pharyngitis/Tonsillitis: 20 mg/kg/day in 1-2 divided doses (max 500 mg/day) for 10 days; Acute Otitis Media: 15 mg/kg q12h for 10 days.
Child: Pharyngitis/Tonsillitis: 20 mg/kg/day in 1-2 divided doses (max 500 mg/day) for 10 days; Acute Otitis Media: 15 mg/kg q12h for 10 days; Acute Sinusitis: 7.5 mg/kg q12h or 15 mg/kg q24h for 10 days; Skin/Skin Structure: 20 mg/kg/day in 1-2 divided doses (max 500 mg/day) for 10 days.
Adolescent: Adult dosing
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Dose Adjustments

Renal Impairment:

Mild: No adjustment (CrCl >30 mL/min)
Moderate: No adjustment (CrCl >30 mL/min)
Severe: 50% of standard dose (CrCl <30 mL/min)
Dialysis: Administer after dialysis

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Cefprozil is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) located in the bacterial cell wall. This binding interferes with the transpeptidation step of peptidoglycan synthesis, leading to the disruption of the cell wall, bacterial lysis, and death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 1.5 hours
FoodEffect: Minimal effect on extent of absorption; Tmax may be delayed by 30-60 minutes.

Distribution:

Vd: Approximately 0.21 L/kg
ProteinBinding: Approximately 36%
CnssPenetration: Limited (does not readily cross the blood-brain barrier in significant amounts unless meninges are inflamed)

Elimination:

HalfLife: Approximately 1.3 hours
Clearance: Primarily renal clearance
ExcretionRoute: Urine
Unchanged: 60-65%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: At Tmax (approximately 1.5 hours)
DurationOfAction: Dependent on half-life and MIC, typically allows for q12h or q24h dosing

Safety & Warnings

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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 medical attention immediately:

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 could 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, although many people may not experience any or may only have mild symptoms. If you notice 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

Reporting Side Effects

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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing. Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it is persistent, bloody, or contains mucus. This could be a sign of a serious intestinal infection (Clostridioides difficile-associated diarrhea).
  • Persistent nausea, vomiting, or abdominal pain.
  • Unusual bruising or bleeding.
  • New signs of infection (e.g., fever, sore throat, vaginal discharge) which could indicate a superinfection.
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any existing health problems.
Your doctor and pharmacist should be aware of all your medications and health issues to verify that it is safe to take this drug in conjunction with your other treatments.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to avoid potential adverse interactions.
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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 impact the results of certain lab tests.

Do not take this medication for longer than prescribed, as this may increase the risk of developing a secondary infection. 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, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Potentially seizures (especially in patients with impaired renal function)

What to Do:

In case of suspected overdose, contact a poison control center immediately (e.g., call 1-800-222-1222 in the U.S.) or seek emergency medical attention. Treatment is supportive. Hemodialysis may be useful in removing the drug from the body in cases of severe overdose or renal impairment.

Drug Interactions

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Major Interactions

  • Warfarin (may enhance anticoagulant effect, monitor INR)
  • Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins)
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Moderate Interactions

  • Probenecid (decreases renal tubular secretion of cefprozil, leading to increased and prolonged plasma concentrations)
  • Live Bacterial Vaccines (e.g., Typhoid vaccine; antibiotics may reduce the therapeutic effect of the vaccine)
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Minor Interactions

  • Oral Contraceptives (theoretical risk of reduced efficacy, generally not clinically significant)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To establish baseline in patients with pre-existing impairment or at risk for renal dysfunction, and for dose adjustment if needed.

Timing: Prior to initiation of therapy if indicated

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Routine Monitoring

Clinical response to therapy

Frequency: Daily during acute phase, then as clinically indicated

Target: Resolution of infection symptoms (e.g., fever, pain, inflammation)

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or alternative diagnosis.

Signs/symptoms of superinfection

Frequency: Daily

Target: Absence of new infections (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Action Threshold: Presence of new symptoms requires evaluation and appropriate management.

Renal function (BUN, serum creatinine)

Frequency: As clinically indicated, especially with prolonged therapy or in patients with pre-existing renal impairment

Target: Within patient's baseline or normal limits

Action Threshold: Significant increase may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Allergic reactions (rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing)
  • Severe or watery diarrhea (especially if persistent or bloody)
  • Nausea
  • Vomiting
  • Abdominal pain
  • Unusual bruising or bleeding
  • New signs of infection (e.g., fever, sore throat, vaginal discharge)

Special Patient Groups

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Pregnancy

Cefprozil is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and human data are limited but do not suggest an increased risk of birth defects. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk based on available data.
Second Trimester: Low risk based on available data.
Third Trimester: Low risk based on available data.
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Lactation

Cefprozil is excreted in very low concentrations into breast milk. Infant risk is generally considered low. Monitor breastfed infants for potential side effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions. Generally considered compatible with breastfeeding.

Infant Risk: Low
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Pediatric Use

Safety and efficacy have not been established in infants younger than 6 months of age. Dosing for infants >6 months and children is weight-based and specific to the indication.

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Geriatric Use

No dosage adjustment is generally necessary based on age alone. However, elderly patients are more likely to have decreased renal function, so renal function should be assessed and monitored, and dosage adjusted if significant impairment is present.

Clinical Information

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Clinical Pearls

  • Cefprozil is a second-generation cephalosporin effective against common respiratory pathogens including *Streptococcus pneumoniae*, *Haemophilus influenzae*, and *Moraxella catarrhalis*.
  • It is generally well-tolerated, with gastrointestinal disturbances (diarrhea, nausea, vomiting) being the most common side effects.
  • Patients with a history of severe penicillin allergy should use cephalosporins with caution due to potential cross-reactivity, although the risk is generally lower with second-generation agents compared to first-generation.
  • The oral suspension must be refrigerated and discarded after 14 days to maintain potency and stability.
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Alternative Therapies

  • Other second-generation cephalosporins (e.g., cefaclor, cefuroxime axetil)
  • Macrolides (e.g., azithromycin, clarithromycin) for certain indications
  • Penicillin derivatives (e.g., amoxicillin, amoxicillin/clavulanate)
  • Other appropriate antibiotics based on culture and susceptibility results, and specific infection type.
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Cost & Coverage

Average Cost: Check current market prices per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic formulations)
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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.