ZAXIME 400 mg 

VN_bigPicture

Cefixime

Tab. 400 mg

Zaxime^® (Cefixime)

Description

Zaxime^® is an oral broad spectrum ß-lactam antibiotic of third generation cephalosporins.

Clinical pharmacology

Zaxime ^® kills bacteria by interfering in the synthesis of the bacterial cell wall. Zaxime ^® binds with high affinity to penicillin binding proteins (PBP) in bacterial cytoplasmic membrane and by acylation of membrane-bound transpeptidase enzymes, prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity.

Also cell division and growth are inhibited and elongation of susceptible bacteria and lysis frequently occur. Rapidly dividing bacteria are those most susceptible to the action of Zaxime ^®.

Antibacterial activity

Zaxime^® has a high degree of stability in the presence of beta-lactamases (penicillinases and cephalosporinases) and, therefore, has excellent activity against a wide spectrum of gram-negative bacteria, including penicillinase-producing strains of N.gonorrhoeae and most enterobacteriaceae (Citrobacter, E.coli Enterobacter, Klebsiella, Morganella, Proteus, Providencia, and Serratia species).

Zaxime ^® has the most activity of oral cephalosporins against Streptococcus pyogenes, S.pneumonia, and all gram-negative bacilli, including beta-lactamase producing strains of H.influenza, M.catarrhalis and N.gonorrhoeae.

Zaxime ^® is not as active against gram-positive cocci as are the first and second generation cephalosporins.

It has a little activity against Staphylococci and has no activity against pseudomonas species.

Pharmacokinetics

Oral absorption ~60%

Presystemic metabolism --

Plasma half – life 2.5-3.8 h

Mean Range 3h

Volume of distribution 0.1 l.kg ^-1

Plasma protein binding 70%

Indication

1-Bronchitis.

2-Bacterial exacerbation of bronchitis.

3-Otitis media.

4-Uncomplicated gonorrhea.

5-Bacterial pharyngitis and tonsillitis.

6-Bacterial urinary tract infections.

Contraindication

Zaxime^® is contraindicated in patients who have shown hypersensitivity to Cefixime or cephalasporin group of antibiotics.

Precaution

· Before Zaxime^® administration, previous hypersensitivity reactions to cephalosporins or penicillins must be determined because of cross hypersensitivity among ß-lactams.

· Risk-benefit should be considered when history of bleeding disorders, gastrointestinal disease specially ulcerative colitis, regional enteritis or antibiotic associated colitis (Zaxime^® may cause pseudomembranous colitis) and hepatic function impairment exist.

· For patients with renal function impairment (creatinine clearance <20mL/min) one half the usual adult dose should be used at the same dosing intervals.

· Long-term therapy with Zaxime^® may allow for the overgrowth of Candida albicans, resulting in oral candidiasis.

· Therapy should be continued for at least 10 days in group a beta-hemolytic streptococcal infections to help prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Pregnancy

Pregnancy category B.

Zaxime ^® cross the placenta. There are no well-controlled studies in pregnant women. Therefore Zaxime ^® should be used during pregnancy only if clearly needed.

Breast feeding

It is not known whether Zaxime ^® is distributed into breast milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Dosage

Usual adult dose

· Bronchitis, bacterial exacerbation of bronchitis, pharyngitis, tonsillitis or uncomplicated urinary tract infections: 200 mg every 12 hours or 400 mg once a day.

· Uncomplicated cervical or urethral gonorrhea: 4