Generic

Cefuroxime Axetil + Clavulanic Acid

Indications

It's used to treat infections caused by bacteria that are susceptible to antibiotics.

• Streptococcus pyogenes causes pharyngitis and tonsillitis.
• Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase generating strains), or Streptococcus pyogenes cause acute bacterial otitis media.
• Streptococcus pneumoniae or Haemophilus influenzae induce acute bacterial maxillary sinusitis (non beta-lactamase producing strains)
• Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and E. coli cause lower respiratory tract infections.
• Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae cause acute bacterial aggravation of chronic bronchitis and secondary bacterial infections of acute bronchitis (beta-lactamase negative strains).
• Staphylococcus aureus (including beta-lactamase generating strains) or Streptococcus pyogenes infections of the skin and skin structures.
• Urinary tract infections produced by E.coli or Klebsiella pneumoniae that aren't too serious.
• Staphylococcus aureus infections of the bones and joints (penicillinase- and non-penicillinase-producing strains).
• Uncomplicated Penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae cause gonorrhoea.
• Borrelia burgdorferi causes early Lyme Disease (erythema migrans).
• Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. cause septicemia.
• Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus can all cause meningitis (penicillinase and non-penicillinase producing strains)
• Therapy with a switch (Injectable to oral)

Pharmacology

Cefuroxime is a bactericidal second-generation cephalosporin antibiotic that kills a wide spectrum of Gram-positive and Gram-negative bacteria, including many beta-lactamase-producing strains. Cefuroxime works by interfering with the transpeptidation process, which stops bacteria from making cell walls.

Streptomyces clavuligerus produces clavulanic acid, a naturally derived beta lactamase inhibitor. It has a structure comparable to beta lactam antibiotics, and it binds to beta-lactamase enzymes and inactivates them irreversibly. Clavulanic acid protects Cefuroxime against breakdown by beta lactamase enzymes, making it a viable therapy option for bacterial infections.

Dosage 

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

Administration

Interaction

The area under the serum concentration versus time curve increases by 50% when probenecid and Cefuroxime-Clavulanic Acid are given together. A drug that lowers stomach acidity may impair Cefuroxime bioavailability and neutralize the impact of postprandial absorption.

Contraindications

Cefuroxime-Clavulanic Acid is not recommended for people who have a known cephalosporin allergy or who have Pseudomembranous Colitis.

Side 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.

Pregnancy & Lactation

Antibiotics should be avoided if at all possible throughout the first trimester. Cefuroxime-Clavulanic Acid, on the other hand, can be safely used to treat urinary and other infections later in pregnancy. Cefuroxime-Clavulanic Acid is excreted in modest amounts in breast milk. However, the possibility of the newborn being sensitized should be considered.

Precautions & Warnings

Cefuroxime should be used with caution in individuals who are taking powerful diuretics and have a history of colitis.

Therapeutic Class

Second generation Cephalosporins

Storage Conditions

Store away from light and moisture in a cool, dry location (below 30° C). Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.