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Cefuroxime Axetil + Clavulanic Acid ·Nuvista Pharma Ltd.·Tablet

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Administration

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

Effects

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.

Indications

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)

Pharmacology

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.