OPSONIN PHARMA LTD.
CEFUROXIME AXETIL + CLAVULANIC ACID
It is indicated for the treatment of infections caused by sensitive bacteria. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes. Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains) 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, E. coli. Acute bacterial exacerbation 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). Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes. Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi. Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains) Switch therapy (Injectable to oral)
Second generation Cephalosporins
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process. Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
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. Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid 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.
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
Generally Cefuroxime-Clavulanic Acid is 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.
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.