MGDOX-CV

COMPOSITION: CEFPODOXIME 200 MG + POTASSIUM CLAVULANIC ACID  125 MG( inner pack)

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Cefpodoxime /Clavulanate Potassium is indicated in the treatment of - Upper & lower respiratory infections - Uncomplicated skin infections - Urinary tract infections

 

fixed dose combination of Cefpodoxime Proxetil and Potassium Clavulanate. Cefpodoxime Proxetil is an orally administered, extended spectrum, semi-synthetic third generation cephalosporin and Clavulanate potassium is a betalactamase inhibitor.

Pharmacokinetics
Cefpodoxime
Cefpodoxime Proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Following oral administration of 100mg of cefpodoxime Proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. Over the recommended dosing range (100 to 400mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours. There is minimal metabolism of cefpodoxime in vivo.

The extent of absorption (mean AUC) and the mean peak plasma concentration increased when film-coated tablets were administered with food. Following a 200mg tablet dose taken with food, the AUC was 21 to 33% higher than under fasting conditions, and the peak plasma concentration averaged 3.1µg/mL in fed subjects versus 2.6 µg/mL in fasted subjects. Time to peak concentration was not significantly different between fed and fasted subjects.

Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma. Half life of cefpodoxime is 2 hours. Concentrations of cefpodoxime in excess of minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, intestinal fluid and prostrate tissue.

Potassium Clavulanate

Clavulanate potassium is well absorbed from the gastrointestinal tract after oral administration . Absorption of clavulanate potassium when taken with food is greater relative to the fasted state.

The half-life of Potassium Clavulanate after the oral administration is 1 hour. Approximately 25% to 40% of the Potassium Clavulanate  is excreted unchanged in urine during the first 6 hours after administration.

Potassium Clavulanate has been found to be approximately 25% bound to human serum. The metabolites are excreted through faeces, in the urine and through the lungs, with 20-60% of the dose being excreted in the form of parent drug.

Contraindication
It is contraindicated in patients with known allergy to penicillin, any other type of beta-lactam drug, cephalosporin class of antibiotic, beta-lactamase inhibitors or any other ingredients of this formulation.

Special Precaution
Pediatrics
Safety and efficacy of both the components  (cefpodoxime and potassium clavulanate) have been established in children age 3 months and older.

Pregnancy
Cefpodoxime: Cefpodoxime Proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at a dose of 30mg/kg/day (1-2times the human dose based on mg/m2)

Clavulanate potassium: The reproductive and developmental toxicity studies on Clavulanic acid are available following oral administration; one generation in rat; teratogenic effect in rat; teratogenic effect in mouse and peri-and post natal development in the rat. However, no adequate and well-controlled studies with cefpodoxime and clavulanate potassium in pregnant women. Because animal reproductions are not always predictive of human response, It should be used during pregnancy only if clearly needed.

Drug Interactions
Antacids or H2-blockers may decrease the absorption of cefpodoxime. Probenecid inhibits renal excretion. Potentially Fatal: Monitor renal function during admin. Additive nephrotoxic effects with furosemide.

 

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