PRODUCT DETAILS

Cefuroxime is one of the bactericidal second generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. It is indicated for the treatment of infections caused by sensitive bacteria. Clavulanic Acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. The presence of Clavulanic Acid in Rofuclav formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

Presentation:

Rofuclav 250/62.5 tablet: Each film coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil USP and Clavulanic Acid 62.5 mg as diluted Potassium Clavulanate BP.

Rofuclav 500/125 tablet: Each film coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil USP and Clavulanic Acid 125 mg as diluted Potassium Clavulanate BP.

  Dosage and Administration

Adolescents & adults:
Pharyngitis or Tonsillitis- 250 mg twice daily - 5 -10 days
Acute bacterial maxillary sinusitis - 250 mg twice daily - 10 days
Acute bacterial exacerbation of chronic bronchitis - 250-500 mg twice daily - 10 days
Secondary bacterial infections of acute bronchitis - 250-500 mg twice daily - 5 -10 days
Community-acquired pneumonia - 250-500 mg twice daily - 5 -10 days
Uncomplicated skin & skin-structure infections - 250-500 mg twice daily - 5 -10 days
MDR Typhoid fever- 500 mg twice daily - 10-14 days
Uncomplicated urinary tract infection - 250 mg twice daily - 7-10 days
Uncomplicated gonorrhea - 1000 mg single dose
Lyme disease - 500 mg twice daily - 20 days
Paediatric patients (3 months to 12 years):
Pharyngitis or Tonsillitis - 20 mg/kg/day in two divided doses - 5 -10 days
Acute otitis media - 30 mg/kg/day in two divided doses - 10 days
Acute bacterial maxillary sinusitis - 30 mg/kg/day in two divided doses - 10 days
Community-acquired pneumonia - 30 mg/kg/day in two divided doses - 5-10 days
MDR Typhoid fever - 30 mg/kg/day in two divided doses - 10-14 days
Uncomplicated skin & skin-structure infections - 30 mg/kg/day in two divided doses - 10 days
Uncomplicated urinary tract infection - 20 mg/kg/day in two divided doses - 7-10 days
RofuclavTM may be administered without regard to meals.

  Side Effects

Generally Cefuroxime and Clavulanic acid are well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

  Contraindications

Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.

  Use in Pregnancy and Lactation

During pregnancy:
All antibiotics should be avoided in the first trimester if possible. However, Rofuclav can be safely used in later pregnancy to treat urinary and other infections.

During lactation:
Rofuclav is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

  Drug Interaction

Concomitant administration of probenecid with Rofuclav increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity mayresult in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.


  Over Dosage

Signs and symptoms:
Over dosage of Rofuclav can cause cerebral irritation leading to convulsions.

Management:
Serum levels of Rofuclav can be reduced by haemodialysis and peritoneal dialysis.

  Storage

Store in a dry place at below 25° C, protect from light.

Keep out of reach of children.

  Commercial Pack

Rofuclav 250/62.5 tablet: Each box contains 2 x 7 s tablets.
Rofuclav 500/125 tablet: Each box contains 2 x 7 s tablets.

Each blister supplied in light protected temper evident zipper pouch to facilitate better storage after every use.

Each pouch contains also a desiccant bag which is not for consumption.

  • Rofuclav