Cefuroxime Axetil for Oral Suspension USP
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 cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.
Cefuroxime is a bactericidal second generation cephalosporin. The in vivo bactericidal 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 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.
INDICATIONS AND USAGE
Cefuroxime axetil for oral suspension is indicated for the treatment of peadiatric patients 3 months to 12 years of age 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
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
DOSAGE AND DIRECTIONS FOR USE
- Most infections – 250 mg twice daily
- Mild to moderate lower respiratory tract infections e.g. bronchitis – 250mg twice daily
- Severe lower respiratory tract infections e.g. pneumonia – 500mg twice daily
- Urinary tract infections – 125mg twice daily
- Pyelonephritis – 250 mg twice daily
- Uncomplicated gonorrhoea – single dose of 1g
- Lyme disease in adults and children over the age of 12 years – 500 mg twice daily for 20 days.
Most Infections (including tonsillitis and pharyngitis) the usual dose is 125 mg (5 ml of suspension) twice daily or 10 mg/kg twice daily to a maximum of 250 mg daily.
3 months – less Than 2 years: for severe or recurrent otitis media infections: usual dosage is 125 mg twice daily or 10 mg/kg twice daily to a maximum of 250 mg daily.
2 years – Less than 12 years: for severe or recurrent otitis media infections: 250mg (10ml of suspension) twice daily or 15mg/kg twice daily to a maximum of 500mg daily
THERE IS NO EXPERIENCE IN CHILDREN UNDER 3 MONTHS OF AGE.
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.
Before reconstitution, store dry powder at a temperature not exceeding 30°C, after reconstitution, immediately store suspension between 2 – 8° C in a refrigerator.
NOT TO BE FOZEN
DISCARD AFTER 10 DAYS.
Protect from light.
Keep medicine out of reach of children.
PRESENTATION: 100 ml amber glass bottle with child lock cap
Olicef® is a registered trade mark of FilGap Healthcare Limited.