TAB.C-POX

CEFPODOXIME PROXETIL 200 mg.

CEFPODOXIME DESCRIPTION Cefpodoxime is an orally administered, semi-synthetic antibiotic, third generation of the cephalosporin class. It has a broad spectrum bactericidal activity that includes staphylococci, streptococci, and Gram-negative species (including Pasteurella, Escherichia, and Proteus). But, it is not active against most obligate anaerobes, Pseudomonas spp., or enterococci. Cefpodoxime is found to be one of the greatest antibiotic which gives excellent result in treating skin and soft tissue infections. Several studies conducted to investigate its efficacy with two dosage patterns of Cefpodoxime. The dosages were 200mg and 400mg twice a day. The results obtained were good in 200mg regime. The clinical cure was 93% in 200mg and 75.9% in 400mg. Trials suggested that Cefpodoxime is one of the most effective antibiotics in the treatment of acute/chronic uncomplicated cystitis. Cefpodoxime has good clinical response to surgical prophylaxis up to 95.4%. Cefpodoxime is well tolerated. Some general adverse reactions such as loose stools, diarrhea, vomiting, nausea, abdominal discomfort are reported. Some female patients who are undergoing treatment for skin and soft tissue infections are some time reported to have vaginitis as adverse reactions but disappear spontaneously as soon as treatment is completed.

CHEMISTRY: The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl(+)-(6R,7R)-7-[2-(2-amino-4- thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.Its empirical formula is C21H27N5O9S2 .

THE CHEMICAL STRUCTURE IS REPRESENTED BELOW:

The molecular weight of Cefpodoxime Proxetil is 557.6. Cefpodoxime proxetil is a prodrug and its active metabolite is Cefpodoxime. MODE OF ACTION:

Like other cephalosporin group of antibiotics, Cefpodoxime exerts its bactericidal action by inhibiting bacterial cell wall synthesis. This inhibition is primarily due to its covalently binding to the penicillin-binding proteins, which are essential for synthesis of the bacterial cell wall. So, Cefpodoxime possesses bactericidal action. Cefpodoxime is stable in the presence of many common ß-lactamases enzymes. As a result, many organisms resistant to other ß-lactam antibiotics (penicillin and some cephalosporin) due to ß-lactamases may be susceptible to Cefpodoxime. Staphylococcus intermedius, Streptococcus canis, Escherichia coli, Pasteurella multocida, Proteus mirabilis, Staphylococcus aureus etc. CLINICAL PHARMACOLOGY: PHARMACOKINETICS:

ABSORPTION: As Cefpodoxime proxetil is a prodrug so, it absorbed from and de-esterified in the gastrointestinal tract to its active metabolite, Cefpodoxime. Bioavailability of Cefpodoxime is 50% in fasting subjects and will increase in presence of food. Peak plasma concentration of Cefpodoxime 200 mg single dose is 2.18 mcg/ml.

DISTRIBUTION: Cefpodoxime is well distributed after oral administration. It reaches therapeutic concentrations in respiratory tract and genito-urinary tracts and bile. Protein binding of Cefpodoxime ranges from 20 to 30 %. ELIMINATION: Cefpodoxime is eliminated from the body primarily in the urine.

PHARMACODYNAMICS:

Plasma half life (t1/2) : 2-3 hours, prolonged in patients with impaired renal function.

Tmax. : 2.21 hours.

Cmax. : 16.4 mcg. /ml.

INDICATION:

TAB.C-POX is indicated in the following infections when caused by susceptible organisms- Acute bacterial exacerbations of chronic bronchitis. Acute community acquired Pneumonia. RTI (Upper and lower). SSTI. UTI. General gonorrhea (men and women) and rectal gonococcal infections (women). Acute maxillary sinusitis.

DOSAGE:

Adults and Children over 10 Years: One tablet 12 hourly. The general duration of course of treatment is 7 days but depending on the severity of disease the duration of treatment may be increase up to 14 days.

WARNINGS and PRECAUTIONS:

As being Cefpodoxime cephalosporin group of antibiotic, so, special test must go through before oral administration to take care from severe penicillin hypersensitivity reaction. Like other antibiotics prolonged use of Cefpodoxime may result over growth of many cephalosporin resistance organisms. Therefore regular investigation is required during Cefpodoxime therapy.

NURSING MOTHERS- As Cefpodoxime is excreted through mother milk, so, before recommending the drug one must consider the important of requirement of the drug. If necessary a nursing mother must stop breast feeding to the baby.

PEDIATRIC USE- Safety profile not yet established for infants less than 2 months.

GERIATRIC USE- Geriatric patient with normal renal function do not require dose adjustment.

ADVERSE EFFECT- TAB.C-POX sometime may manifest very rare and negligible side effects like- Diarrhea, Headache, nausea, Abdominal Pain etc.

Normally the duration of treatment should not be exceed for 14 days.