Sedox Powder for Suspension

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Cefpodoxime is indicated for the treatment of patients infected with susceptible strains of microorganisms which include a wide range of gram-positive & gram-negative bacteria. As it is highly stable in presence of β-lactamase enzyme, so it is more effective against gram-positive bacteria than other 3rd generation oral cephalosporins. The susceptible organisms include gram-positive bacteria eg. S. aureus (including penicillinase producing strains), S. saprophyticus, S. pneumoniae, S. pyogenes, S. agalactiae, P. magnus and gram-negative bacteria eg. E. coli, K. pneumoniae, H. influenzae (including β-lactamase producer & Ampicillin resistant strains), M. catarrhalis, N. gonorrhoeae (including penicillinase producing strains), P. mirabilis, C. diversus, H. parainfluenzae, K. oxytoca, P. vulgaris, P. rettgeri.

Adults and Adolescents (13 years and older)-

• Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
• Community-acquired pneumonia: 200 mg 12 hourly, 14 days
• Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
• Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
• Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
• Uncomplicated gonorrhea: single dose of 200 mg
• Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)-

• Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
• Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Patients with renal dysfunction: For patients with severe renal impairment (creatinine clearance <30ml/min) the dosing intervals should be increased to 24 hourly.

Patients with liver cirrhosis: Cefpodoxime Proxetil pharmacokinetics in cirrhotic patients are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminium hydroxide) or H 2 blockers reduce peak plasma level by 24% to 42% and the extent of absorption by 27% to 32%, respectively.

Probenecid: Renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC.

Nephrotoxic drugs: Close monitoring of renal function is advised when Sedox is administered concomitantly with compounds of known nephrotoxic potential.

Cefpodoxime Proxetil is contraindicated in patients with a known allergy to Cefpodoxime or to the cephalosporin group of antibiotics.

Sedox has very few side effects. The side effects include diarrhea, nausea, skin & vaginal fungal infection, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, cough etc. In children incidence of fungal skin rash is more than adults.

Cefpodoxime was neither teratogenic nor embryocidal in animal trial. There is, however, no adequate and well-controlled study of Cefpodoxime Proxetil use in pregnant woman. The drug should be used during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made wheather to discontinue breast-feeding or to discontinue the drug.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Sedox should be reduced. Sedox, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other broad spectrum antibiotics, prolonged use of Sedox may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential.

Third generation Cephalosporins

For 50 ml suspension: Add 30 ml (6 teaspoonful or with the help of the provided cup) of cooled boil water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Keep in a dry place away from light and heat. Keep out of the reach of children.