CEFUREX Cefuroxime Axetil 500mg Film-Coated Tablet 40's
Indications/Uses
Patients With Renal Failure: The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.
Dosage/Direction for Use
Cefuroxime axetil oral suspension must be administered with food. Although cefuroxime axetil film-coated tablets may be given orally without regard to meals, administration with food maximizes bioavailability of the drug.
Cefuroxime Axetil for Oral Suspension: Cefuroxime axetil for Oral Suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in the table: See table.
Patients With Renal Failure: The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.
Overdosage
Administration
Contraindications
Warnings
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefuroxime, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Special Precautions
Cefuroxime, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of Cefuroxime has not been established in patients with gastrointestinal malabsorption. Patients with gastrointestinal malabsorption were excluded from participating in clinical trials of Cefuroxime.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing Cefuroxime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Drug/Laboratory Test Interactions: A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution) but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving Cefuroxime. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity was found for Cefuroxime in a battery of bacterial mutation tests. Positive results were obtained in an in vitro chromosome aberration assay; however, negative results were found in an in vivo micronucleus test at doses up to 1.5 g/kg. Reproduction studies in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) have revealed no impairment of fertility.
Use in Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 3,200 mg/kg/day (14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the fetus due to Cefuroxime. 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.
Labor and Delivery: Cefuroxime has not been studied for use during labor and delivery.
Use in Lactation: Because cefuroxime is excreted in human milk, consideration should be given to discontinue nursing temporarily during treatment with Cefuroxime.
Use in Children: The safety and effectiveness of Cefuroxime has been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based on its approval in adults. Use of Cefuroxime in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled studies of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. It is also supported by postmarketing adverse events surveillance.
Use in Elderly: Of the total number of subjects who received Cefuroxime in 20 clinical studies of Cefuroxime, 375 were 65 and over while 151 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. The geriatric patients reported somewhat fewer gastrointestinal events and less frequent vaginal candidiasis compared with patients aged 12 to 64 years old; however, no clinically significant differences were reported between the elderly and younger adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.
Use In Pregnancy & Lactation
Labor and Delivery: Cefuroxime has not been studied for use during labor and delivery.
Use in Lactation: Because cefuroxime is excreted in human milk, consideration should be given to discontinue nursing temporarily during treatment with Cefuroxime.
Adverse Reactions
The following convention has been used for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon, (≥1/1000, <1/100,) rare (≥1/10,000, <1/1000), very rare (<1/10,000).
Infections and infestations: Common: Candida overgrowth.
Blood and lymphatic system disorders: Common: Eosinophilia. Uncommon: Positive Coombs' test, thrombocytopenia, leukopenia (sometimes profound). Very rare: Haemolytic anaemia.
Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.
Immune system disorders: Hypersensitivity reactions including Uncommon: Skin rashes. Rare: Urticaria, pruritus. Very rare: Drug fever, serum sickness, anaphylaxis.
Nervous system disorders: Common: Headache, dizziness.
Gastrointestinal disorders: Common: Gastrointestinal disturbances including diarrhoea, nausea, abdominal pain. Uncommon: Vomiting. Rare: Pseudomembranous colitis.
Hepatobiliary disorders: Common: Transient increases of hepatic enzyme levels, [ALT (SGPT), AST (SGOT), LDH]. Very rare: Jaundice (predominantly cholestatic), hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis).
Renal and Urinary tract disorders: Very Rare: interstitial nephritis.
Drug Interactions
Caution For Usage
To make a 50 mL Suspension: Add 24 mL boiled and cooled water up to the mark on the bottle. Swirl to dissolve the granules. Shake the bottle to ensure uniformity. The reconstituted suspension should be stored at 2°C to 8°C and used within five days.
Storage
Action
Pharmacokinetics: After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimum absorption occurs when it is administered after a meal. Peak serum cefuroxime levels occur approximately two to three hours after oral dosing. The serum half life is about 1.2 hours. Approximately 50% of serum cefuroxime is protein bound. Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion. Concurrent administration of probenecid increases the area under the mean serum concentration time curve by 50%. Serum levels of cefuroxime are reduced by dialysis.
Microbiology: Cefuroxime Axetil owes its in vivo bactericidal activity to the parent compound, cefuroxime. Cefuroxime is a well-characterized and effective antibacterial agent which has broad-spectrum bactericidal activity against a wide range of common pathogens, including beta-lactamase-producing strains. Cefuroxime has good stability to bacterial beta-lactamase and consequently, is active against many ampicillin-resistant and amoxicillin-resistant strains. The bactericidal action of cefuroxime results from inhibition of cell-wall synthesis by binding to essential target proteins.
Cefuroxime is usually active against the following organisms in vitro: Aerobes, Gram-negative: Haemophilus influenzae (including ampicillin-resistant strains); Haemophilus parainfluenzae; Moraxella catarrhalis; Escherichia coli; Klebsiella species; Proteus mirabilis, Proteus inconstans; Providencia species; Proteus rettgeri and Neisseria gonorrhoea (including penicillinase and non-penicillinase-producing strains).
Some strains of Morganella morganii, Enterobacter species and Citrobacter species have been shown by in vitro tests to be resistant to cefuroxime and other beta-lactam antibiotics.
Aerobes, Gram-positive: Staphylococcus aureus (including penicillinase-producing strains but excluding methicillin-resistant strains); Staphylococcus epidermidis (including penicillinase-producing strains but excluding methicillin-resistant strains); Streptococcus pyogenes (and beta-haemolytic streptococci), Streptococcus pneumoniae; Streptococcus Group B (Streptococcus agalactiae) and Propionibacterium species.
Certain strains of enterococci, eg. Streptococcus faecalis, are resistant.
Anaerobes, Gram-positive and Gram-negative cocci (including Peptococcus and Peptostreptococcus species); Gram-positive bacilli (including Clostridium species) and Gram-negative bacilli (including Bacteroides and Fusobacterium species). Most strains of Bacteroides fragilis are resistant.
Other organisms, Borrelia burgdorferi.
Pseudomonas species, Campylobacter species, Acinetobacter calcoaceticus, Listeria monocytogenes, Legionella species and most strains of Serratia and Proteus vulgaris and Clostridium difficile are resistant to many cephalosporins including cefuroxime.
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Features
- Cefuroxime