Cefuroxime Axetil

FORMULATION
Each film-coated tablet contains:
Cefuroxime Axetil USP
Eq. to Cefuroxime …. 500 mg

DESCRIPTION
A white to off white coloured oblong shaped, biconvex film coated tablet with a break line on one side and plain in other side.

MECHANISM OF ACTION
Cefuroxime inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell walls biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall assembly is arrested.

PHARMACOKINETICS
Absorption: Oral (cefuroxime axetil): Increased when given with or shortly after food or infant formula ( 37% to 52%)
Distribution: Widely distributed to body tissue and fluids; crosses blood-brain barrier; therapeutic concentrations achieved in CFS even when meninges are not inflamed.
Protein binding: 33% to 50%
Bioavailability, axetil: Oral :37% to 52%
Half-life:
Neonates: less than or equal to 3 days: 5.1-5 8hours; 6-14 days: 2-4.2hours; 3-4 weeks: I-1 5 hours
Adults: 1-2 hours (prolonged in renal impairment)
Time to peak serum concentration: I.M.: Within 15-60 minutes.
Elimination: Primarily excreted 66% to 100% as unchanged drug in urine by both glomerular filtration and tubular secretion.

INDICATIONS
For the treatment of infections due to sensitive Gram-positive and Gram-negative bacteria. It is more active against Haemophilus influenzae and Neisseria gonorrhea. It is also used for Iyme disease and as surgical prophylaxis.

DOSAGE AND ADMINISTRATION
Adults: 500 mg twice daily. UTI                                  125 mg twice daily
Adults:
Uncomplicated Urinary Tract Infections                     125 mg twice daily
Respiratory Tract                                                        250 to 500 mg twice daily
Infections Lyme disease                                             500 mg twice daily for 20 days
Children: (More than 3 months)
Uncomplicated Urinary Tract Infections &                 125 mg twice daily or 10 mg/kg
Respiratory Tract                                                        twice daily to a max of 250 mg daily
Otitis Media                                                                250 mg twice daily or 15 mg/kg twice daily
to a max of 500 mg daily

Or as directed by the physician.

CONTRAINDICATIONS
Hypersensitivity to cefuroxime, any component, or cephalosporins.

ADVERSE EFFECTS
1% to 10%:
Hematologic: Eosinophilia (7%) decreased hemoglobin and Hematocrit (10%)
Hepatic: Increased transaminases (4%), increased alkaline phosphatase (2%)
Local: Thrombophlebitis (I .7%) Anaphylaxis, erythema multiforme, toxic epidermal necrolysis, Stevens- Johnson syndrome, interstitial nephritis, dizziness, fever, headache, rash, vomiting, diarrhea, stomach cramps, Gl bleeding, colitis, neutropenia, leukopenia, increased creatinine, increased BUN, vaginitis, seizures, angioedema, pseudomembranous colitis. Other reactions with cephalosporins include toxic nephropathy, cholestatis, agranulocytosis, colitis, pancytopenia, aplastic anemia, hemorrhage, prolonged P T, encephalopathy, asterixis, neuromuscular excitability, serum-sickness reactions, superinfection.

DRUG INTERACTIONS
Increased effect: High-dose probenecid decreases clearance.
Increased toxicity: Aminoglycosides increase nephrotoxic potential.

SPECIAL PRECAUTIONS
Modify dosage in patients with severe renal impairment, prolonged use may result in superinfection; use with caution in patients with a history of penicillin allergy, especially lgE mediated reactions (eg, anaphylaxis, urticaria); may cause antibiotic-associated colitis or colitis secondary to C. difficile.

CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORAGE CONDITION
Store at temperatures not exceeding 300C.

Keep all medicines out of reach of children.

Price/SRP:

• SRP 40.00 per tablet

“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph“