Ximacef
Capsules & Powder For Oral Suspension
Composition:
Capsule:
XIMACEF 200 mg capsules: cefixime 200 mg 1 cap.
XIMACEF 400 mg capsules: cefixime 400 mg 1 cap.
Suspension:
XIMACEF 100 mg cefixime 15 ml suspension in Bottle contains 30 ml- after reconstitution.
XIMACEF 100 mg cefixime 15 ml suspension in Bottle contains 60 ml – after reconstitution.
Properties:
XIMACEF is cefixime, a semisynthetic cephalosporin antibiotic for oral administration.
XIMACEF is a highly stable Cephalosporin antibiotic even in the presence of Beta – lactamase enzyme. Therefore microorganisms that are resistant to Penicillin and other Cephalosporins due to the presence of Beta-Iactamase enzymes are susceptible to
XIMACEF.
Microbiology:
XIMACEF is active against most strains of the following microorganisms: Gram positive: Strept. pneumoniae, Strept. pyogones and strept. agalactiae Gram negative H. influenzae, N. gonorrhoeae, B. caterrhalis, E.coli, K.pneumoniae, P.mirabilis, Salmonella sp., Citrobacter sp., Shigella sp. and Serratia sp.
Contraindications:
XIMACEF is contraindicated in patients with known allergy to cephalosporin group of antibiotics.
Precautions:
The possibility of the emergence of resistant organisms should be kept in mind, particularly during prolonged treatment. Patients on dialysis should be monitored carefully as following:
Creatinine clearance ml/min Dose
> 60 ml/min Normal dose
21 – 60 mll min – Hemodialysis 300 mg I day
20 mll min – CAPD 200 mg I day
Drug interaction :
No significant drug interaction has been reported to 1
Nursing mothers:
Consideration should be given to discontinuing nursing temp
during treatment with Cefixime.
Pediatric use:
Safety and effectiveness of Cefixime in children less than 6 rnr
old have not been established.
Indications:
– Uncomplicated urinary tract infection caused by E.coli and P.mirabilis.
-Upper respiratory tract infection
-Otitis media and sinusitis caused by H.influenzae and B. caterrhalis (Beta lactamase positive and negative)
– Pharyngitis and tonsillitis caused by S. pneumoniae.
– Lower respiratory tract infection .
-Acute bronchitis and acute bacterial exacerbation of chronic bronchitis caused by S.pneumoniae, H. influenzae and B. caterrhalis (Beta lactamase positive and negative)
– Uncomplicated gonorrhea caused by N. gonorrhoeae .
Side effects:
Like other Cephalosporins, XIMACEF side effects are mild and transient in nature including:
some gastrointestinal disturbance like nausea, vomiting or mild diarrhoea. Hypersensitivity reactions were reported as skin rash and pruritus. Transient elevation of SGPT and SGOT and alkaline phosphatase.
Transient elevations in BUN or creatinine. Headache or dizziness. Transient thrombocytopenia. leukopenia, and eosinophilia.
Dosage:
Adults and children over 12 years old (50 kg body weight): 400 mg capsule once daily or 200 mg capsule twice daily.
Children: 8 mg I kg I day once daily or in two equally divided doses.
Instructions for reconstitution of XIMACEF powder for oral suspension:
Loosen the bottle contents; add water in two portions with shaking after each addition, till the level of mark.
Shake the bottle before use.
Presentation:
XIMACEF 400 mg capsules: one blister contains 5 capsules.
XIMACEF 200 mg capsules: one blister contains 8 capsules.
XIMACEF 100 mgl 5 ml suspension: Bottle contains 30 ml – after reconstitution.
XIMACEF 100 mgl 5 ml suspension: Bottle contains 60 ml – after reconstitution.
Produced by:
Sigma-Tec Pharmaceutical Industries. Egypt. SAE.
