Rofurox 500

Indications of Rofurox 500mg Tablet

Rofurox 500mg Tablet is used to treat infections caused by bacteria that are susceptible to antibiotics.

• 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.

• E.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 of Rofurox 500mg Tablet

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.

 

Rofurox 500mg Tablet Dosage & Administration

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, the dose can be increased up to 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 a freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

 

Contraindications

Cefuroxime is not recommended for people who have a Cephalosporin allergy.

 

Rofurox 500mg Tablet Side Effects

Cefuroxime has been linked to a small number of side effects, all of which have been minor and temporary. Rashes and stomach issues have been mentioned as side effects. Prolonged usage of amoxicillin, like other drugs, can lead to the proliferation of non-susceptible organisms like Candida.

 

Pregnancy & Lactation

Cefuroxime is classified as a pregnancy category B by the US Food and Drug Administration. However, no suitable and well-controlled studies in pregnant women have been conducted. Because animal reproduction studies do not always predict human response, this medication should only be used during pregnancy if absolutely necessary. Human milk has been found to contain cefuroxime. When Cefuroxime is given to a nursing woman, caution should be observed.

 

Precautions & Warnings

Cefuroxime should be used with caution in individuals who are taking powerful diuretics and have a history of colitis. Although there have been reports of cross-reactions, cephalosporin medicines can often be given safely to patients who are hypersensitive to penicillin. Cefuroxime has proven that at the recommended dose levels, this is unlikely to be an issue.

 

Therapeutic Class

Second generation Cephalosporins

 

Storage Conditions

Store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name of Rofurox 500mg Tablet

Radiant Pharmaceuticals Limited

 

Generic

Cefuroxime Axetil