Cefpodoxime Proxetil 50 mg Clavulanate Potassium 31.25 mg Dry Syrup

Cross hypersensitivity in penicillin sensitive patients, leading to serious acute hypersensitivity reactions may need treatment with epinephrine along with other emergency measures such as intravenous fluids, oxygen, airway management, and intravenous antihistamine, as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antimicrobial agents, including cefpodoxime tablets, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted, as clinically indicated.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime should be reduced because high and prolonged serum antibiotic concentrations can occur in such individuals following usual doses. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics.

As with other antibiotics, prolonged use of cefpodoxime may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Cefpodoxime :

Incidence greater than 1% include #Diarrhea: 7%; Nausea: 3.3%; Vaginal Fungal Infections:1%; Vulvovaginal Infections:1.3%; Abdominal Pain: 1.2%; and Headache:1%

Number of diarrhea or loose stools were dose related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. difficile organism or toxin in the stool.

Other adverse events consists of difficulty breathing or swallowing, Hives, Itching, Mild skin rash, Painful mouth or throat sores, Severe skin rash, Sore throat, Unusual bleeding or bruising, Upset stomach, Vaginal infection, Vomiting, and Wheezing.

Clavulanic Acid :

Side effects include bloody diarrhea, bloody urine, painful or difficult urination, unusual weakness, easy bleeding and bruising, confusion, dry mouth, increased urination, chills, body aches, fever, sore throat, headache, seizures, chest pain and irregular heartbeat. These side effects are very rare and do not affect a large amount of users. Treatment should not normally exceed 14 days.

Cefpodoxime

Cefpodoxime has shown efficacy against most strains of the following microorganisms, both in vitro and in clinical infections.

Gram-positive Aerobes:

Staphylococcus aureus (including penicillinase-producing strains)
Staphylococcus saprophyticus
Streptococcus pneumoniae (excluding penicillin resistant strains)
Streptococcus pyogenes

Aerobic Gram-negative Microorganisms:

Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Haemophilius influenzae (including beta lactamase strains)
Moraxella (Branhmella) catarrhalis
Nesseria gonorrhoeae (including penicillinase-producing strains)

The following in vitro data are available, but their clinical significance is unknown. Cefpodoxime exhibits in vitro minimum inhibitory concentrations (MICs) of ≤ 2.0 mcg/mL against most (≥90%) of isolates of the following microorganisms. However, the safety and efficacy of cefpodoxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Aerobic Gram-positive Microorganisms:

Streptococcus agalactiae
Streptococcus spp. (Groups C, F, G)

Aerobic Gram-negative Microorganisms:

Citrobacter diversus
Klebsiella oxytoca
Proteus vulgaris
Providencia rettgeri
Haemophilus parainfluenzae

Anaerobic Gram-positive Microorganisms:

Peptostreptococcus magnus

Clavulanic Acid

Clavulanic acid is a fermentation product of Streptomyces clavuligerus, and a beta-lactam compound with penicillin like structure. It has the capability to inactivate a broad spectrum of betalactamases through blocking their active sites. Clavulanic acid is specifically active against the clinically important plasmid-mediated beta-lactamases.

Cefpodoxime, a relatively new broad-spectrum third-generation cephalosporin, has very good in vitro activity against Enterobacteriaceae, Hemophilus spp. and Moraxella spp., including β-lactamase producers and many strains resistant to other oral agents. It also has activity against Gram-positive bacteria, especially against streptococci.

Cefpodoxime, which possesses characteristics of the third-generation cephalosporins, has been investigated in large numbers of patients with upper and lower respiratory tract infections, urinary tract infections (UTIs), or skin and soft tissue infections (SSTIs).

The international clinical experience with this drug has confirmed its efficacy in treating pharyngotonsillitis with 97% to 100% success rates in adults, and 92% to 100% in pediatric patients. In lower respiratory tract infections, cefpodoxime has proven efficacious in bronchial infections (84% to 97% success rate), and in bacterial pneumonia (favorable outcome in 81.8% to 100% of cases). In UTIs, SSTIs, and pediatric infections a more limited experience has provided favorable results, with an efficacy rate ranging from 77% to 95% of cases.