Cefpodoxime Proxetil IP 200 mg Clavulanic Acid 125 mg Tablet

• Tell your doctor and pharmacist if you are allergic to cefpodoxime or any other cephalosporin antibiotic such as cefadroxil or cephalexin, penicillin, or any other drugs.
• Tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other antibiotics, anticoagulants (‚blood thinners‚) such as warfarin, probenecid, and vitamins.
• Tell your doctor if you have or have ever had kidney or liver disease, colitis, or stomach problems.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cefpodoxime, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking cefpodoxime.

• Hypersensitivity reactions to cefpodoxime, other cephalosporins, penicillins, or other drugs.
• If cefpodoxime is to be administered to penicillin sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
• The medication is contraindicated in patients with a history of hepatic, kidney and stomach ailments.
• Diarrhea
• Nausea
• Vaginal Fungal Infections
• Vulvovaginal Infections
• Abdominal Pain
• Headache
• Dry mouth

The recommended dosages, duration of treatment and applicable patient population are as described in the following table:

Disclaimer:To be taken only after consulting with the doctor.

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 beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria species, and Moxaxella catarrhalis, which are referred as the most common hospital acquired and community acquired infections. Clavulanic acid is a natural inhibitor of beta lactamase, which are 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.

Pharmacology

Cefpodoxime Proxetil
Absorption:Bioavailability of cefpodoxime is 50% in fasting subjects and it increases in presence of food. Peak plasma concentration of Cefpodoxime 200 mg single dose is 2.18 mcg/ ml.
Distribution: The Drug is well distributed after oral administration. Cefpodoxime reaches therapeutic concentrations in respiratory tract and genito-urinary tracts and bile. Protein binding of cefpodoxime ranges from 20 to 30 %.
Half Life: The plasma half life of cefpodoxime is about 2 to 3 hours and is prolonged in patients with impaired renal function.
Elimination:Cefpodoxime is excreted unchanged in urine.

Clavulanic Acid
Absorption: Clavulanic acid is well absorbed after oral administration. Peak plasma concentration of Clavulanic acid 125 mg single dose is 2.2 mcg/ml.
Distribution: It is distributed completely after 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. The clavulanic acid component in the drug combination protects cefpodoxime from degradation by Beta-lactamase enzymes, and effectively extends the antibiotic spectrum of cefpodoxime to include many bacteria that are normally resistant to cefpodoxime and other Beta-lactam antibiotics.

Antacids: Concomitant administration of high doses of antacids (sodium and aluminum hydroxide) or H₂ blockers reduces peak plasma levels by 24% to 42% and the extent of absorption by 27% to 32%, respectively. The rate of absorption is not altered by these concomitant medications. Oral anti-cholinergics (e.g., propantheline) delay peak plasma levels (47% increase in Tmax), but do not affect the extent of absorption (AUC).
Probenecid:As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and 20% increase in peak cefpodoxime plasma levels.
Nephrotoxic Drugs: Although nephrotoxicity has not been noted when cefpodoxime proxetil was given alone, close monitoring of renal function is advised when cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.
Drug/Laboratory Test Interactions: Cephalosporins, including cefpodoxime proxetil, are known to occasionally induce a positive direct Coombs‚ test.

• Tablet should be swallowed whole without chewing.
• It should be taken with food to enhance absorption of the drug.
• If you miss a dose of tablet, contact your doctor.
• In case of overdose

In the event of a serious toxic reaction from overdosage, haemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime and clavulanic acid from the body, particularly if renal function is compromised. The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress and diarrhoea.

Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4- thiazolyl)-2-{(Z)methoxyimino}acetamido]-3methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate. Its empirical formula is C21H27N5O9S2. The molecular weight of cefpodoxime proxetil is 557.6.

Clavulanic acid is orally administered, beta-lactamase inhibitor. The chemical name is (2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid. The molecular weight of clavulanic acid is 199.16076 g/mol.