Combocef^®

Combocef^® is a combination of Cefpodoxime and Clavulanic Acid effective against multiple gram-positive and gram-negative bacteria and has well established safety and efficacy profile.
Cefpodoxime is an orally administered extended spectrum antibiotic of 3rd generation cephalosporin class.
The Clavulanic Acid in Combocef® protects Cefpodoxime from degradation by

The Clavulanic Acid in Combocef® protects Cefpodoxime from degradation by β -lactamase enzymes and effectively extends the spectrum to include many bacteria normally resistant to Cefpodoxime and other beta-lactam antibiotics. Thus, Combocef® possesses the distinctive properties of a broad spectrum antibiotic and a β lactamase inhibitor.

No Data

Combocef^® is indicated for the treatment of-

• URTis                                                                   • SSTis

     o Pharyngitis                                                 • UTis
     o Tonsillitis                                                     • Uncomplicated gonorrhea and rectal gonococcal infections
     o Acute maxillary sinusitis                       • Uncomplicated gonorrhea and rectal gonococcal infections

• LRTis
     o Acute community acquired pneumonia
     o Acute bacterial exacerbations of chronic bronchitis

Dosage schedule for adults (Age 12 years and older)

Type of lnfection	Total Daily Dosage	Dosage Frequency	Duration
Pharyngitis and/or tonsillitis	200mg	100 mg 12 hourly	5 to 10 days
Acute community acquired pneumonia	400mg	200 mg 12 hourly	14 days
Acute bacterial exacerbations of chronic bronchitis	400mg	200 mg 12 hourly	10 days
Uncomplicated gonorrhea and rectal gonococcal infections	200mg	Single dose
Skin and skin structure infections	800mg	400 mg 12 hourly	7 to 14 days
Acute maxillary sinusitis	400mg	200 mg 12 hourly	10 days
Uncomplicated urinary tract infection	200mg	100 mg 12 hourly	7 days
Enteric fever	400mg	200 mg 12 hourly	7 to 14 days

Patients with renal dysfunction
For patients with severe renal impairment ( < 30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.

Patients with cirrhosis
Cefpodox.ime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

Pediatric use
Safety and efficacy in infants less than 2 months of age have not been established.

Geriatric use
Dose adjustment in elderly patients with normal renal function is not necessary.

Pregnancy
Both Cefpodoxime and Clavulanic Acid are pregnancy category B.
Lactation

Cefpodoxime is excreted in human milk, so a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Special population
Patients with renal dysfunction
For patients with severe renal impairment ( < 30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
Patients with cirrhosis
Cefpodox.ime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.
Pediatric use
Safety and efficacy in infants less than 2 months of age have not been established.
Geriatric use
Dose adjustment in elderly patients with normal renal function is not necessary.

No Data

Cross hypersensitivity in penicillin sens1tJve 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. In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodox.ime 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.

This combination is well tolerated. Most common gastro-intestinal adverse effects seen is diarrhoea, nausea, vomiting and abdominal pain.

It is contraindicated in patients with known allergy to Cefpodoxime and Clavulanic Acid or to the Cephalosporin group of antibiotics.

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduce peak plasma level by 24% to 42% and the extent of absorption by 27% to 32% respectively.

Probenecid: Renal excretion of Cefpodox.ime Proxetil was inhibited by Probenecid and resulted in an approximately 31 % increase in AUC.

Nephrotox.ic drugs: Close monitoring of renal function is advised when Cefpodox.ime Proxetil is administered concomitantly with compounds of known nephrotox.ic potential.

In case of over dosage, it is recommended to eliminate the ingested drug by repeated administration of high doses of activated charcoal. Forced diuresis is expected to accelerate the elimination of Tizanidine. Future treatment should be symptomatic.

No Data

Store in a cool (below 25°C) & dry place. Protect from light.

Combocef^® 100 Tablet : Each coated tablet contains Cefpodox.ime 100 mg as Proxetil USP and Clavulanic Acid 62.5 mg as diluted Potassium Clavulanate BP.

Combocef^® 200 Tablet : Each coated tablet contains Cefpodoxime 200 mg as Proxetil USP and Clavulanic Acid 125 mg as diluted Potassium Clavulanate BP.

Combocef^® 100 Tablet : Carton of 12 tablets in blister pack.

Combocef^® 200 Tablet : Carton of 12 tablets in blister pack.