Cefprozil

Mechanism-of-action class: Enzyme Inhibitors.

• Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Upper Respiratory Tract: Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes . NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route.ICD-10: J02.9, J03.90

• Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.contraindicated

Cefprozil tablets are administered orally. Population / Infection Dosage ( mg ) Duration ( days ) a In the treatment of infections due to Streptococcus pyogenes, cefprozil tablets should be administered for at least 10 days. b Not to exceed recommended adult doses. ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10 a Acute Sinusitis 250 q12h or 10 (For moderate to severe infections, the higher dose should be used) 500 q12h LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or 10 500 q24h or 500 q12h CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACT b Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10 a SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT b Otitis Media 15 mg/kg q12h 10 (See INDICATIONS AND USAGE and CLINICAL STUDIES ) Acute Sinusitis 7.5 mg/kg q12h or 10 (For moderate to severe infections, the higher dose should be used) 15 mg/kg q12h Renal Impairment: Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used. Creatinine Clearance ( mL / min ) Dosage ( mg ) Dosing Interval 30 to 120 standard standard 0 to 29 Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG ß-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFPROZIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefprozil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events. The most common adverse effects observed in patients treated with cefprozil are: Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%). Hepatobiliary: Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely. Hypersensitivity: Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy. CNS: Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible. Hematopoietic: Decreased leukocyte count (0.2%), eosinophilia (2.3%). Renal: Elevated BUN (0.1%), serum creatinine (0.1%). Other: Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).

Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weanling, or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality. Cefprozil is eliminated primarily by the kidneys. In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of cefprozil from the body.

• Dec 6, 2005ANDAANDA065208Teva
• Dec 8, 2005ANDAANDA065276Lupin
• Dec 19, 2005ANDAANDA065261Lupin
• Jan 30, 2007ANDAANDA065381Aurobindo Pharma
• May 24, 2007ANDAANDA065340Aurobindo Pharma
• Apr 9, 2024ANDAANDA090857Alkem Labs Ltd

1. 1Chronic Kidney Disease8911%
2. 2Drug Hypersensitivity739.4%
3. 3Cough648.2%
4. 4Acute Kidney Injury597.6%
5. 5Dyspnoea587.5%
6. 6Rash577.3%
7. 7Pneumonia557.1%
8. 8Pyrexia557.1%
9. 9Fatigue526.7%
10. 10Renal Failure526.7%
11. 11Diarrhoea496.3%
12. 12Urticaria496.3%
13. 13Arthralgia435.5%
14. 14Drug Ineffective425.4%
15. 15Abdominal Pain415.3%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Cefprozil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
  Recruiting · Phase 4 · Interventional · 236 enrolled · Medical College of Wisconsin
  NCT06494072updated 2026-03-02
• Cefprozil for Oral Suspension 250 mg/5 mL, Fasting
  Completed · Phase 1 · Interventional · 26 enrolled · Teva Pharmaceuticals USA
  NCT00835614updated 2024-08-20
• Cefprozil 500 mg Tablets Under Fasting Conditions
  Completed · Phase 1 · Interventional · 38 enrolled · Teva Pharmaceuticals USA
  NCT00840281updated 2024-08-20
• Cefprozil 500 mg Tablets Under Fed Conditions
  Completed · Phase 1 · Interventional · 39 enrolled · Teva Pharmaceuticals USA
  NCT00840866updated 2024-08-20
• Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting
  Completed · Phase 1 · Interventional · 26 enrolled · Teva Pharmaceuticals USA
  NCT00835354updated 2024-08-20
• Patients Response to Early Switch To Oral:Osteomyelitis Study
  Terminated · Early phase 1 · Interventional · 11 enrolled · Julio Ramirez
  NCT02099240updated 2021-04-06
• Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers
  Completed · Phase 1 · Interventional · 60 enrolled · The Affiliated Hospital of Qingdao University
  NCT04414254updated 2020-06-04
• Comparative Effectiveness of Antibiotics for Respiratory Infections
  Completed · Observational · 2,472 enrolled · Children's Hospital of Philadelphia
  NCT02297815updated 2019-07-08
• To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions
  Completed · Phase 1 · Interventional · 24 enrolled · Sandoz
  NCT00881400updated 2017-03-29
• To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
  Completed · Phase 1 · Interventional · 26 enrolled · Sandoz
  NCT00881426updated 2017-03-29

Frequently asked questions

How does Cefprozil work?

Mechanism-of-action class: Enzyme Inhibitors.

What is Cefprozil used for?

According to FDA labeling, Cefprozil carries indications including: Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Upper Respiratory Tract: Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes . NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cefprozil?

Cefprozil is classified as Second-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the contraindications for Cefprozil?

Cefprozil labeling lists contraindications including: Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.. Always consult the full prescribing information and a clinician.