OLICEF® 250 TABLETS/ OLICEF® 500 TABLETS
Cefuroxime Axetil Tablets BP 250 mg/ 500 mg
OLICEF tablets contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.
Cefuroxime is a bactericidal second generation cephalosporin. The antibacterial action of cefuroxime results from inhibition of bacterial cell wall synthesis by binding to essential target proteins in bacterial cytoplasmic membranes. Cefuroxime has bactericidal activity against a wide range of bacterial organisms, including beta lactamase producing strains.
ABSORPTION AND METABOLISM
Cefuroxime axetil is an oral prodrug of cefuroxime. After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to release cefuroxime into the plasma. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.
The in vivo bactericidal activity of cefuroxime axetil is due to its binding to essential target proteins and the resultant inhibition of cell-wall synthesis. Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase-producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Cefuroxime has been demonstrated to be active against most strains of the following microorganisms both in vitro and in clinical infections.
INDICATIONS AND USAGE
Cefuroxime axetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Upper respiratory tract infections (ear, nose and throat infections) such as, otitis media, sinusitis, tonsillitis and Pharyngitis.
- Lower respiratory tract infections such as, pneumonia, acute bronchitis, and acute exacerbation of chronic bronchitis.
- Genito-urinary tract infections for example, pyelonephritis, cystitis, urethritis.
- Skin and soft tissue infections such as, furunculosis, pyoderma and impetigo.
- Gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis
DOSAGE AND DIRECTIONS FOR USE:
Cefuroxime axetil should be taken half an hour after food for optimum absorption.
The usual course of therapy is seven days (range 5 – 10 days)
|* The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.|
|† Cefuroxime axetil for oral suspension may be better suited for certain dosages in the pediatric population.|
|Adolescents and Adults (13 years and older)|
|Upper respiratory tract infections|
|Pharyngitis/tonsillitis||250 – 500 mg b.i.d.||10|
|Acute bacterial maxillary sinusitis||250 – 500 mg b.i.d.||10|
|Lower respiratory tract infections|
|Acute bacterial exacerbations of chronic bronchitis||250 – 500 mg b.i.d.||10*|
|Secondary bacterial infections of acute bronchitis||250 – 500 mg b.i.d.||5 to 10|
|More severe lower respiratory tract infections e.g. Pneumonia||500mg b.i.d||10|
|Skin and skin structure infections|
|Uncomplicated skin and skin-structure infections||250 or 500 mg b.i.d.||10|
|Urinary tract infections|
|Uncomplicated urinary tract infections: Acute uncomplicated Cystitis||250 mg b.i.d.||7 to 10|
|Pyelonephritis||250 mg b.i.d.||7 to 10|
|Uncomplicated gonorrhea||1,000 mg once||single dose|
|Early Lyme disease||500 mg b.i.d.||20|
|Pediatric Patients (who can swallow tablets whole)†|
|Acute otitis media||250 mg b.i.d.||10|
|Acute bacterial maxillary sinusitis||250 mg b.i.d.||10|
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefuroxime, and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.
Patients who develop abdominal or stomach cramps, abdominal tenderness, severe and watery diarrhoea (which may be bloody) and fever should be investigated for this diagnosis. If the diagnosis of pseudomembraneous colitis is suspected or established, Cefuroxime Axetil should be stopped immediately and appropriate therapy initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug effective against Clostridium difficile.
Generally, Cefuroxime Axetil should be used with caution in patients with :
- A history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or pseudomembraneous colitis.
- Prolonged use of Cefuroxime Axetil may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci or Clostridium difficile).
- Renal function impairment – A reduced dose may be required.
- Porphyria: Safety has not been established.
- The Jarisch-Herxheimer reaction has been reported following treatment with Cefuroxime Axetil for Lyme disease. This reaction is a common and usually self-limiting consequence of antibiotic treatment for Lyme disease.
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Gastrointestinal: Nausea, vomiting, abdominal pain, diarrhoea, in some cases accompanied by blood in stools, which may be a symptom of enterocolitis. A particular form of enterocolitis is pseudomembraneous colitis.
Kidney/Genitourinary: Vaginal candidiasis
Liver: Transient increases in hepatic enzyme levels
Skin: Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis
Others: Hypersensitivity reactions including skin rashes, urticaria, pruritus, bronchospasm, drug fever, serum sickness, anaphylaxis.
Store at a temperature not exceeding 30°C, in a dry place. Protect from light.