Rofuclav 250/62.5

Indications of Rofuclav 250/62.5

Pharyngitis/tonsillitis caused by Streptococcus pyogenes Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta lactamase-producing strains only) Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains) Skin and Skin-Structure infections caused by Staphylococcus aureus (penicillinase and non penicillinase producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp. and Enterobacter spp. Urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae Bone and Joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains)  Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains) in both males and females Early Lyme disease (erythema migrans) caused by Borreli burgdorferi Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains) Switch therapy (injectable to oral) after surgery when patient's condition is improved.

Pharmaceutical Name of Rofuclav 250/62.5

Radiant Pharmaceuticals Ltd

Pharmacology

Cefuroxime is a bactericidal second generation cephalosporin antibiotic that is effective against a broad variety of Gram-positive and Gram-negative susceptible pathogens, including numerous beta-lactamase generating strains. Cefuroxime works by interfering with the transpeptidation process, which affects bacterial cell wall production.

Clavulanic acid is a beta lactamase inhibitor isolated from Streptomyces clavuligerus. It has a similar structure to beta lactam antibiotics in that it binds to and inactivates beta-lactamase enzymes irreversibly. Clavulanic acid protects Cefuroxime from breakdown by beta lactamase enzymes and offers a therapeutic option for bacterial infections caused by beta lactam resistant bacteria.

Dosage & Administration of Rofuclav 250/62.5

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Interaction of Rofuclav 250/62.5

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

Contraindications

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

Side Effects of Rofuclav 250/62.5

Cefuroxime-Clavulanic Acid is generally well tolerated. Some adverse effects, such as nausea, vomiting, diarrhea, stomach discomfort, or pain, may occur. Prolonged use of the Cefuroxime and Clavulanic acid combination, like other broad-spectrum antibiotics, may result in the proliferation of nonsusceptible bacteria. Renal failure, anaphylaxis, angioedema, pruritis, rash, and serum sickness such as urticaria may occur infrequently (0.2 percent).

Pregnancy & Lactation

During pregnancy:

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

During lactation:

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

Precautions & Warnings

RofuclavTM should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.

Therapeutic Class

Antibacterial

Storage Conditions

Store in a dry place at below 25° C, protect from light. Keep out of reach of children.

Generic Name of Rofuclav 250/62.5

Cefuroxime+Clavulanic Acid

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