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Major Pharma Products of GSK Bangladesh

Respiratory: Seretide/Ventolin Inhaler


Antiinfectives:
Zinnat/Amoxil/Cexime/Glaxipro
Analgesics: Parapyrol/Pandol Extra
Dermatology:
Dermovate/Bactroban/Cutivate/Fluvin-
OD
Cexime (Cefixime) :

..a balanced approach


Cefixime
Cefixime is an oral 3rd generation cephalosporin. Excellent
efficacy against a broad spectrum of pathogens including
Haemophilus influenzae, Streptococcus pneumoniae and
Moraxella catarrhalis. Cefixime also possesses excellent
activity against beta-lactamase- producing strains.
Cefixime
Pharmacodynamic features of the drug include:

 A half life of 3-4 hour and a Cmax of 4.4 Ig/ml.


 Well above the MIC90 for susceptible pathogens

 Permitting once-daily dosing.


Indications:
 Uncomplicated Urinary Tract infection caused by E. coli and P.
mirabilis
 Otitis media caused by H influenzae (beta-lactamase positive
and negative strains), Moraxella catarrhalis and S. pyogenes.
 Pharyngitis and Tonsillitis caused by S. pyogenes.
 Acute Bronchitis and Acute Exacerbations of Chronic
Bronchitis, caused by S. pneumoniae and H. influenzae (beta-
lactamase positive and negative strains)
 Uncomplicated gonorrhea (cervical/urethral) caused by N.
gonorrhoeae.
Study reports

Clinical efficacy and safety of Cefixime in RTI in children and adults:

In URTI: A total of 95 children with upper RTI were eligible for analysis, 45
with acute sinusitis and 50 with acute otitis media. Following treatment
with once daily cefixime suspension, clinical cure or improvement was
obtained in 45 (100%) and 48 (96%) patients with sinusitis and otitis
media respectively. Only 2 failures were noted, both in the otitis media
group.

S. Karger AG, Basel, Chemotherapy 1998;44 (suppl 1):31-34


Study reports

Clinical efficacy and safety of Cefixime in RTI in children and adults:

In LRTI: In adults, 60 patients with acute exacerbations of chronic bronchitis


(AECB) according to the Winnipeg type I classification and 12 with
pneumonia were analyzed following cefixime treatment. Clinical results in
adults with AECB (n=60) and pneumonia (n=12).

S. Karger AG, Basel, Chemotherapy 1998;44 (suppl 1):31-34


Study report

Efficacy of cefixime in typhoid fever

The study carried out at the University General Hospital, a secondary


care facility in San Luis Potosi City, Mexico from March 1997 to
September 1999. This study included 24 adult and pediatric patients.
All pediatric patients received doses of 5 mg/kg of cefixime, twice
daily. Adult patients received a dose of 200 mg, twice daily.
At the end of the study 23 (96%) patients showed clinical cure. Clinical
relapse was observed in one case (4%) at day 8 after start of
treatment.
Safety Profile of Cefixime

There are no specific problems associated with


cefixime that are not reported for other
cephalosporins. The clinical features of cefixime
make it an important first line choice for
physicians against a variety of common infections
encountered in daily practice.

S. Karger AG, Basel, Chemotherapy 1998;44 (suppl 1):1-5


Dosage & Administration

Adult & child over 10 years: 200-400 mg daily as a single dose or in


divided doses

Child dose: 8mg/kg daily as a single dose or in two divided doses for
7-14 days according to the severity of the
infection.
Side effects

Cefixime is generally well tolerated. The majority of


adverse reactions observed in clinical trials were mild and
self-limiting in nature. Gastro-intestinal disturbances,
diarrhoea, changes in the colour of stool, nausea,
abdominal pain, dyspepsia, vomiting, flatulence have been
reported. Central nervous system disturbances: headache,
dizziness. Others: hypersensitivity reactions, infrequent
and reversible hematological changes, elevation of serum
amylase.
Preparations of Cefixime of GSK

CeximeTM 200 capsule: Box containing 2 X 7 capsules in Alu-Alu


blister pack

CeximeTM Granules for suspension: Bottle containing powder for the


preparation of 50 ml suspension. After reconstitution each 5 ml
contains cefixime 100mg as cefixime 100mg as cefixime 100 mg as
cefixime trihydrate USP.
Thank you

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