Overview
DESCRIPTION Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6 R ,7 R )-7-[( R )-2-Amino-2-( p -hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.
Mechanism of Action
CLINICAL PHARMACOLOGY The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions. Following oral administration of cefprozil to fasting subjects, approximately 95% of the dose was absorbed. The average plasma half-life in normal subjects was 1.3 hours, while the steady-state volume of distribution was estimated to be 0.23 L/kg. The total body clearance and renal clearance rates were approximately 3 mL/min/kg and 2.3 mL/min/kg, respectively. Average peak plasma concentrations after administration of 250 mg, 500 mg, or 1 g doses of cefprozil to fasting subjects were approximately 6.1, 10.5, and 18.
Indications
- INDICATIONS AND USAGE 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.
Common Doses
- 7.5 mg
- 20 mg
- 15 mg
Dosage
DOSAGE AND ADMINISTRATION 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...
Contraindications
- CONTRAINDICATIONS Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Side Effects
- ADVERSE REACTIONS 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 (
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.