COMPOSITION: – CEFPODOXIME PROXETIL 100MG & POTASSIUM CLAVULANATE 62.5MG ORAL SUSPENSION.
Cefpodoxime Proxetil USP is an orally administered, extended-spectrum, semi-synthetic antibiotic of the cephalosporin class. Cefpodoxime Proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime.
MECHANISM OF ACTION: Cefpodoxime, a third-generation semi-synthetic cephalosporin, exhibits activity against several gram-positive as well as gram-negative microorganisms. This compound is also stable in the beta-lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible staphylococci, streptococcs pneumonia, haemophilus influenza, nesseria spp, and moxaxella catarrhalis, which are referred to as the most common hospital-acquired and community-acquired infections. Clavulanic acid is a natural inhibitor of beta-lactamase, which is produced by streptomyces clavuligerus. It binds to beta-lactamase moieties and inactivates them, thus restricting the cefpodoxime destruction. Clavulanic acid has very little antimicrobial activity.
- ABSORPTION: Bioavailability of cefpodoxime is 50% in fasting subjects and it increases in the presence of food. Peak plasma concentration of cefpodoxime 200mg single dose is 2.18mcg/ml.
- DISTRIBUTION: The drug is well distributed after oral administration. Cefpodoxime reaches therapeutic concentrations in the respiratory tract and genitor-urinary tracts and bile.
- PROTEIN BINDING of cefpodoxime ranges from 20 to 30%.
- HALF-LIFE: The plasma half-life of Cefpodoxime is 2-3 hours and it’s prolonged in patients with impaired renal function.
- ELIMINATION: Cefpodoxime is excreted unchanged in the urine.
- ABSORPTION: Clavulanic acid is well absorbed after oral administration. Peak plasma concentration of clavulanic acid 125mg single dose is 2.2mcg/ml.
- DISTRIBUTION: it is distributed completely after the oral administration.
- PROTEIN BINDING of clavulanic acid is about 30%.
- HALF LIFE: The plasma half-life of clavulanic acid is one hour
- ELIMINATION: About 60% of clavulanic acid is excreted unchanged in urine.
- Acute bacterial exacerbations of chronic bronchitis
- Acute community-acquired pneumonia
- Upper and lower respiratory tract infections
- Skin and soft tissue infections
- Urinary tract infections
- Pharyngitis and/ or tonsillitis
- General gonorrhea (men and women) and rectal gonococcal infections (women)
- Acute maxillary sinusitis