Prescribing Details
Description
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.
Uses
No Data
Indications
Indication
Cerox CV® is indicated for the treatment of the following infections due to susceptible bacteria:
- Pharyngitis or tonsillitis
- Acute bacterial otitis media
- Acute bacterial maxillary sinusitis
- Acute bacterial exacerbations of chronic bronchitis
- Uncomplicated skin and skin-structure infections
- Uncomplicated urinary tract infections
- Uncomplicated gonorrhea Early Lyme disease
- Early Lyme disease
- Impetigo
Dosage and administration
Route of administration: Cerox CV® should be taken in oral route.
Adult patients and pediatric patients dosage guidelines for Cerox CV® tablets
| Infection | Dosage | Duration (days) |
|---|---|---|
| Adults and adolescents (13 years and older) | ||
| Pharyngitis or tonsillitis (mild to moderate) | 250 mg every 12 hours | 10 |
| Acute bacterial maxillary sinusitis (mild to moderate) | 250 mg every 12 hours | 10 |
| Acute bacterial exacerbations of chronic bronchitis (mild to moderate) | 250 mg or 500gm every 12 hours | 10* |
| Uncomplicated skin and skin-structure infections | 250 mg or 500gm every 12 hours | 10 |
| Uncomplicated urinary tract infections | 250 mg every 12 hours | 7 to 10 |
| Uncomplicated gonorrhea | 1000 mg | Single dose |
| Early Lyme disease | 500 mg every 12 hours | 20 |
| Pediatric patients younger than 13 years (who can swallow tablets whole)** | ||
| Acute bacterial otitis media | 250 mg every 12 hours | 10 |
| Acute bacterial maxillary sinusitis | 250 mg every 12 hours | 10 |
| Infection | Recommended daily dose*** | Maximum daily dose | Duration (days) |
|---|---|---|---|
| Pharyngitis or tonsillitis | 20 mg/kg | 500 mg | 10 |
| Acute bacterial otitis media | 30 mg/kg | 1000 mg | 10 |
| Acute bacterial maxillary sinusitis | 30 mg/kg | 1000 mg | 10 |
| Impetigo | 30 mg/kg | 1000 mg | 10 |
| Dosing in adults with renal impairment | |
|---|---|
| Creatinine clearance (ml/min) | Recommended dosage |
| ≥30 | No dosage adjustment |
| 10 to <30 | Standard individual dose given every 24 hours |
| <10 (without hemodialysis) | Standard individual dose given every 48 hours |
| Hemodialysis | A single additional standard dose should be given at the end of each dialysis |
Use in pregnancy & lactation
Pregnancy: There are limited data from the use of this combination in pregnant women. This combination should be prescribed to pregnant women only if the benefit outweighs the risk.
Lactation: Cefuroxime is excreted in human milk. No data are available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this combination and any potential adverse effects on the breastfed infant from this combination or from the underlying maternal condition.
Use in children and adolescents
Use in children and adolescents has been described in the dose and administration section.
Geriatric use
Precautions
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime and may range in severity from mild diarrhea to fatal colitis, If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.
Side effects
The most common side effects for cefuroxime and clavulanic acid tablets are diarrhea, nausea or vomiting, Jarisch-Herxheimer reaction and vaginitis (early Lyme disease). The most common side effects for cefuroxime and clavulanic acid oral suspension are diarea, dislike of taste, diaper rash and nausea or vomiting.
Contraindications
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.
Drug interactions
Drug interaction with medication: Drugs that reduce gastric acidity may result in a lower bioavailability of this combination compared with administration in the fasting state. Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime.
Drug interaction with food and others: Not applicable.
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.
Preparation
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.
Pharmaceutical precautions
Store in a cool {below 25°C) and dry place protected from light. Keep away from the reach of children.
Presentation
Cerox CV 125 tablet: Carton of 12 tablets in blister pack in sachet.
Cerox CV 250 tablet: Carton of 12 tablets in blister pack in sachet.
Cerox CV 500 tablet: Carton of 14 tablets in blister pack in sachet.
Cerox CVⓇ powder for suspension: Bottle of 70 ml with food grade dropper.
Package quantities
No Data
