Description
Generics: Cefuroxime Axetil.
Dosage Form: Tablet.
Indications:
It is indicated for the treatment of infections caused by sensitive bacteria.
- Streptococcus pyogenes causes pharyngitis and tonsillitis.
- Streptococcus pneumonia, Haemophilus influenza, Moraxella catarrhalis (beta-lactamase generating strains), or Streptococcus pyogenes cause acute bacterial otitis media.
- Streptococcus pneumonia or Haemophilus influenza induces acute bacterial maxillary sinusitis (non beta-lactamase-producing strains)
- Streptococcus pneumonia, Haemophilus influenza (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 pneumonia, Haemophilus influenza (beta-lactamase negative strains), or Haemophilus parainfluenza 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. - coli or Klebsiella pneumonia infections of the urinary tract.
- Staphylococcus aureus infections of the bones and joints (penicillinase- and non-penicillinase-producing strains).
- Penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae cause gonorrhoea.
- Borrelia burgdorferi causes early Lyme Disease (erythema migrans).
Pharmacology:
Cefuroxime is a well-studied and potent antibacterial drug with broad-spectrum bactericidal activity against a variety of infections, including those that produce -lactamases. Cefuroxime is resistant to bacterial -lactamase and thus efficacious against a wide range of ampicillin- and amoxicillin-resistant strains.
Dosage guideline:
Three times in daily.
Tablet or Suspension-
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 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
Parenteral-
- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
- Children (above 3 months of age): 30 – 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
- Neonate: 30 – 100 mg/kg/day given in 2 or 3 equally divided doses.
- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
- Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
In Meningitis:
- Adult: 3 gm IV injection three times daily.
- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
- In bone and joint infections:
- Adult: 1.5 gm IV injection four times daily.
- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Route of administration: Orally.
Interaction:
No potentially hazardous interactions have been reported.
Contraindications:
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
Side Effects:
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
Pregnancy & Lactation:
US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
Precautions & Warnings:
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
Therapeutic Class:
Second generation Cephalosporins
Storage Conditions:
Keep in a cool and dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: Aristopharma Ltd
