Cerox CV 125 tablet: Each tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
Cerox CV 250 tablet: Each tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.
Cerox CV 500 tablet: Each tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.
Cerox CV powder for suspension: After reconstitution, each 5 ml contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and Potassium Clavulanate BP equivalent to Clavulanic Acid 31.25 mg.
Cerox CV ® is a combination of Cefuroxime Axetil and Clavulanic Acid. Cefuroxime is a bactericidal second generation cephalosporin antibiotic and Clavulanic Acid is a beta-lactamase inhibitor. Cefuroxime Axetil acts by inhibition of bacterial cell wall synthesis. Cefuroxime Axetil has activity in the presence of some ß-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. The Clavulanic Acid in Cerox CV Ⓡ protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the spectrum to include many bacteria normally resistant to Cefuroxime and other beta-lactam antibiotics. Thus, Cerox CV ® possesses the distinctive properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.
Route of administration: Cerox CV® should be taken in oral route. Adult patients and pediatric patients dosage guidelines for Cerox CV ® tablets:
Adults and adolescents (13 years and older):
Pharyngitis or tonsillitis (mild to moderate): 250 mg every 12 hours for 10 days
Acute bacterial maxillary sinusitis (mild to moderate): 250 mg every 12 hours for 10 days
Acute bacterial exacerbations of chronic bronchitis (mild to moderate): 250 mg or 500mg every 12 hours for 10 days*
Uncomplicated skin and skin-structure infections: 250 mg or 500mg every 12 hours for 10 days
Uncomplicated urinary tract infections: 250 mg every 12 hours for 7 to 10 days
Uncomplicated gonorrhea: 1000 mg Single dose
Early Lyme disease: 500 mg every 12 hours for 20 days
Pediatric patients younger than 13 years (who can swallow tablets whole)**:
Acute bacterial otitis media: 250 mg every 12 hours for 10 days
Acute bacterial maxillary sinusitis: 250 mg every 12 hours for 10 days
**When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.
Pediatric patients (3 months to 12 years) dosage guidelines for Cerox CV ® oral suspension:
Pharyngitis or tonsillitis: 20 mg/kg daily (Max 500 mg) for 10 days
Acute bacterial otitis media: 30 mg/kg daily (Max 1000 mg) for 10 days
Acute bacterial maxillary sinusitis: 30 mg/kg daily (Max 1000 mg) for 10 days
Impetigo: 30 mg/kg daily (Max 1000 mg) for 10 days
***Recommended daily dose given twice daily divided in equal doses.
Impaired renal function:
>=30 ml/min: No dosage adjustment
10 to <30 ml/min: Standard individual dose given every 24 hours
<10 ml/min (without hemodialysis): Standard individual dose given every 48 hours
Hemodialysis: A single additional standard dose should be given at the end of each dialysis
Direction for preparation or reconstitution of suspension:
Shake the bottle well before mixing the water. To prepare 70 ml suspension, add 40 ml (8 teaspoonfuls) boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water. The reconstituted suspension must be kept in 2°C -8°C temperature in a refrigerator and consumed within 7 days after reconstitution.
Probenecid competitively inhibits renal tubular secretion, increasing cefuroxime concentrations; drugs that reduce gastric acidity (PPIs, antacids, H2 antagonists) lower cefuroxime axetil bioavailability; aminoglycosides increase nephrotoxic potential; oral anticoagulants exhibit increased INR.
This combination is contraindicated in patients with a known hypersensitivity to cefuroxime or clavulanic acid or other ß-lactam antibacterial drugs (e.g., penicillins and cephalosporins) or any other components of this product.
Common: Diarrhea, nausea, vomiting, vaginitis. Less Common: Dislike of taste, diaper rash (pediatric). Rare: Jarisch-Herxheimer reaction.
Overdose
Overdose of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Category B. Limited clinical data in pregnant women; use only if benefit clearly outweighs risk. Lactation: Cefuroxime is excreted in breast milk; caution should be exercised.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep away from the reach of children.