- BETA-LACTAM ANTIBIOTICS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Dry Powder for oral suspension
- Composition : Cefixime ( as trihydrate ) 100 mg / 5 ml Susp
- Active Substance : Cefixime
Cefixime is a broad spectrum semisynthetic cephalosporin antibiotic for oral administration .
The bactericidal action of Cefixime results from inhibition of cell-wall synthesis . Cefixime is
highly beta-lactamase stable and as a result , many organisms resistant to penicillins and some
cephalosporins ,due to the presence of beta-lactamases , are susceptible to Cefixime .
Sopraxymed has been shown to be active against most strains of the following Gram-positive and
Gram-negative organisms :
Streptococcus pneumoniae , Streptococcus pyogenes , Streptococcus agalactiae, Haemophilus
influenzae, Haemophilus parainfluenzae , Moraxella ( Branhamella ) Catarrhalis, Escherichia coli,
Proteus mirabilis, Proteus vulgaris , Neisseria gonorrhoeae,Klebsiella oxytoca, Pasteurella
multocida, Providencia species, Salmonella species ,Shigella species , Citrobacter diversus ,
Serratia marcescens .
Sopraxymed is indicated in the treatment of the following :
Pharyngitis ,tonsillitis and sinusitis .Acute bronchitis and acute exacerbations of chronic bronchitis,
Otitis media ,Uncomplicated urinary tract infections .Uncomplicated urethral or cervical gonorrhea
Contraindications : Cefixime is contraindicated in patients with known allergy to cephalosporin
group of Antibiotics
before therapy is instituted,careful inquiry should be made to determine whether the
patient has previous hypersensitivity reactions to cephalosporins , penicillins , or other drugs.
Precautions : Prolonged use of antibiotics may result in overgrowth of non-susceptible organisms.
Pregnancy and lactation : Pregnancy category B : Reproduction studies have been performed in
mice at doses up to 400 times the human dose and have reveated no evidence of harm to the fetus
due to Cefixime Because animal reproduction studies are not always predictive of human response ;therefore, this drug Should be used during pregnancy only if clearly needed .It is not known whether Cefixime is excreted in human milk ; However problems in humans have not been documented to date
Side effects :
Side effects are mild and transient in nature ; the following have been reported :
Pseudomembranous colitis diarrhea, abdominal pain, nausea,vomiting, skin reshes,urticaria ,
transient elevation in liver enzymes .
Gastric lavage may be indicated ; otherwise , no specific antidote exists. Cefixime is not removed
in significant quantities from the circulation by hemodialysis or peritoneal dialysis . Adverse
reactions in healthy adult volunteers receiving single doses up to 2gr ofCefixime did not differ from
the profile seen in patients treated at the recommended doses.
DOSAGE & ADMINISTRATION :
Children : The recommended dose is 8mg/kg/day of suspension . This may be administered as a
single daily dose or may be given in two divided doses,as 4mg/kg every 12 hours..
Storage conditions : store below 25o c
invert bottle and shake to loosen powder. Add pre-boiled cool water in two portions
to the dry substance in bottle. Shake bottle well after each addition until the reconstituted
suspension align to the mark level on bottle.
Storage conditions : store below 25o c , keep refrigerated after reconstitution , used within 14 days after reconstitution .
Sopraxymed 100 : 60 ml Dry powder for oral suspension.