Kilbac – IM/IV Injection 250mg

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).
• Skin and skin structure infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
• Urinary tract infections caused by E.coli or Klebsiella pneumonia.
• Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
• Gonorrhoea is caused by penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae.
• Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

Pharmacology

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and Amoxycillin-resistant strains.

Dosage

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 anesthesia; 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.

Administration

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 5o C

Interaction

No potentially hazardous interactions have been reported.

Contraindications

Cefuroxime is contraindicated in patients with known allergies to Cephalosporins.

Side Effects

Adverse effects of 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 nonsusceptible organisms e.g. Candida.

Pregnancy & Lactation

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies on 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 has 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 have a history of colitis. Cephalosporin antibiotics may, in general, be given safely to patients who are hypersensitive to penicillin although cross reactions have been reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

Reconstitution

For 750 mg intramuscular injection: Add 3 ml water for injection to the vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to the vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to the vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Storage Conditions

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