Fetnal

Fetnal

cefuroxime

Manufacturer:

Brawn Labs

Distributor:

Ambica

Marketer:

Ambica
Full Prescribing Info
Contents
Cefuroxime axetil.
Action
Pharmacology: In vivo bactericidal activity of cefuroxime axetil is due to cefuroxime's 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 β-lactamase-producing strains. Cefuroxime is stable to many bacterial β-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Pharmacokinetics: Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood to cefuroxime; absorption is enhanced in the presence of food. Peak plasma concentrations (Cmax) are reported about 2-3 hrs after an oral dose. The sodium salt is given by IM or IV injection. Peak plasma concentrations of about 27 mcg/mL have been achieved 45 min after an IM dose of 750 mg with measurable amounts present 8 hrs after a dose. Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life (t½) is about 70 min and is prolonged in patients with renal impairment and in neonates. Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and aqueous humor, but only achieves therapeutic concentrations in the cerebrospinal fluid (CSF) when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion, and high concentrations are achieved in the urine. On injection, most of a dose of cefuroxime is excreted within 24 hrs, the majority within 6 hrs. Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime.
Small amounts of cefuroxime are excreted in bile.
Plasma concentrations are reduced by dialysis.
Indications/Uses
Treatment of susceptible infections including bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis (although treatment failures have been reported in Haemophilus influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin (including soft tissue infections) and urinary tract infections (UTI). It is also used for surgical infection prophylaxis.
Dosage/Direction for Use
Uncomplicated UTI: 125 mg twice daily.
Respiratory Tract Infections: 250-500 mg twice daily.
Children >3 months: 125 mg twice daily or 10 mg/kg twice daily to a maximum of 250 mg daily.
Otitis Media: Children >2 years: 250 mg twice daily or 15 mg/kg twice daily to a maximum of 500 mg daily.
Pneumonia or Acute Exacerbations of Chronic Bronchitis: Adults: 1.5 g twice daily or 750 mg twice daily, respectively in parenteral route followed by oral cefuroxime 500 mg twice daily in each case.
Lyme Disease: Adults: 500 mg twice daily for 20 days.
Uncomplicated Gonorrhea: 1 g single oral dose can be given. In each case, an oral dose of probenecid 1 g may be given with cefuroxime.
Contraindications
Hypersensitivity to cephalosporin antibiotics.
Special Precautions
Cefuroxime axetil should be given with caution to patients with renal impairment, dosage reduction may be necessary. Renal and hematological status should be monitored especially during prolonged and high-dose therapy. Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhea during or after antibiotic use.
Use in pregnancy: Cefuroxime axetil should be administered with caution during the early months of pregnancy. Fetnal should not be used during pregnancy only if clearly needed.
Use in lactation: Cefuroxime is excreted in human milk and consequently, caution should be exercised when cefuroxime axetil is administered to a nursing mother.
Use In Pregnancy & Lactation
Use in pregnancy: Cefuroxime axetil should be administered with caution during the early months of pregnancy. Fetnal should not be used during pregnancy only if clearly needed.
Use in lactation: Cefuroxime is excreted in human milk and consequently, caution should be exercised when cefuroxime axetil is administered to a nursing mother.
Adverse Reactions
Gastrointestinal disturbances including diarrhea, nausea and vomiting have occurred in some patients receiving cefuroxime axetil. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. Mild to moderate hearing loss has been reported in some children given cefuroxime for the treatment of meningitis.
Drug Interactions
Probenecid reduces the renal clearance of cefuroxime.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg x 10's. 500 mg x 10's, 50's, 100's.
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