CEFIX (CAPSULES / DRY POWDER
FOR ORAL SUSPENSION)
CEFIX (cefixime) is a semisynthetic, cephalosporin
antibiotic for oral administration.
CEFIX is available in powder for oral suspension in a
dose 100 mg /5 ml , 200 mg and 400 mg capsules.
CEFIX, given orally, is about 40% to 50% absorbed
whether administered with or without food.
Peak serum concentrations occur between 2 and 6 hours
following oral administration of a single 200 mg capsule
, a single 400 mg capsule.
Approximately 50% of the absorbed dose is excreted
unchanged in the urine in 24 hours.
The serum half-life of cefixime in healthy subjects is
independent of dosage from and averages 3 to 4 hours,
but may range up to 9 hours in some normal volunteers.
In subjects with moderate impairment of renal function
(20 to 40 ml/min creatinine clearance), the average
serum half-life of cefixime is prolonged to 6.4 hours.
In severe renal impairment (5 to 20 ml/min creatinine
clearance) the half-life increased to an average of 11.5
hours. The drug is not cleared significantly from the
blood by hemodialysis.
Adequate data on CSF levels of CEFIX are not available.
As with other cephalosporins, bactericidal action of
CEFIX results from inhibition of cell-wall synthesis.
CEFIX is highly stable in the presence of beta-lactamase
As a result, many organisms resistant to penicillins and
some cephalosporins due to the presence of beta-lactamase,
may be susceptible to CEFIX.
CEFIX has been shown to be active against most strains
of the following organisms.
- Streptococcus pneumoniae.
- Streptococcus pyogenes.
Haemophilus influenzae (beta-lactamase positive and
negative strains), moraxella (branhamella) catarrhalis
(most of which are beta-lactamase positive), escherichia
coli, proteus mirabilis, neisseria gonorrhoeae
(including penicillinase- and non- penicillinase-producing
Note: pseudomonas species, strains of group D
streptococci (including enterococci), Listeria
monocytogenes, most strains of staphylococci (including
methicillin-resistant strains) and most strains of
enterobacter are resistant to cefixime. In addition,
most strains of bacteroides fragilis and clostridia are
resistant to CEFIX.
INDICATIONS AND USAGE:
CEFIX (cefixime) is indicated in the treatment of the
Uncomplicated urinary tract infections: caused by
Escherichia coli and proteus mirabilis.
Otitis media: Caused by Haemophilus influenzae
(beta-lactamase positive and negative strains),
Moraxella (Branhamella) catarrhalis (most of which are
beta-lactamase positive) and Streptococcus pyogenes.
Pharyngitis and tonsillitis: Caused by S.
CEFIX is generally effective in the eradication of S.
pyogenes from the nasopharynx.
Acute bronchitis and acute exacerbations of chronic
bronchitis: Caused by S. pneumoniae and H.
influenzae (beta-lactamase positive and negative
Uncomplicated gonorrhea (cervical/urethral):
Caused by Neisseria gonorrhoeae (penicillinase- and non–penicillinase-producing
CEFIX is contraindicated in patients with known allergy
to the cephalosporin group of antibiotics.
Before therapy with CEFIX is instituted, careful inquiry
should be made to determine whether the patient has had
previous hypersensitivity reactions to cephalosporins,
penicillins, or other drugs.
If an allergic reaction to CEFIX occurs, discontinue the
drug. Serious acute hypersensitivity reactions may
require treatment with epinephrine and other emergency
measures, including oxygen, intravenous fluid,
intravenous antihistamines, corticosteroids, pressor
amines, and airway management, as clinically indicated.
Treatment with broad-spectrum antibiotics, including
CEFIX, alters the normal flora of the colon and may
permit overgrowth of clostridia.
The possibility of the emergence of resistant organisms
which might result in overgrowth should be kept in mind,
particularly during prolonged treatment. In such use,
careful observation of the patient is essential, if
superinfection occurs during therapy, appropriate
measures should be taken.
The dose of CEFIX should be adjusted in patients with
renal impairment as well as those undergoing continuous
ambulatory peritoneal dialysis (CAPD) and hemodialysis
(HD). Patients on dialysis should be monitored
CEFIX should be prescribed with caution in individuals
with a history of gastrointestinal disease, particularly
Carbamazepine: elevated carbamazepine levels have been
reported in experience when CEFIX is administered
Pregnancy category B: It has revealed no evidence
of harm to the fetus due to CEFIX. There are no adequate
and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if
Nursing mothers: It is not known weather CEFIX is
excreted in human milk. Consideration should be given to
discontinuing nursing temporarily during treatment with
Pediatric use: Safety and effectiveness of CEFIX
in children aged less than 6 months old have not been
Most of the adverse reactions observed in clinical
trials were of a mild and transient nature.
The most commonly seen adverse reactions were:
Gastrointestinal events: Individual event rates
included diarrhea 16%, loose or frequent stools 6%,
abdominal pain 3%, nausea 7% dyspepsia 3%, and
These symptoms usually responded to symptomatic therapy
or ceased when CEFIX was discontinued.
Hypersensitivity reactions: skin rashes,
urticaria, drug fever, and pruritus. Erythema multiform.
Stevens-Johnson syndrom, and serum sickness-like
reactions have been reported.
Hepatic: transient elevations in SGPT, SGOT, and
Renal: transient elevations in BUN or creatinine.
Central nervous system: Headaches or dizziness.
Hemic and lymphatic system: transient
thrombocytopenia, leukopenia, and eosinophilia,
prolongation in prothrombin time was seen rarely.
Other: genital pruritus, vaginitis, candidiasis.
Renal dysfunction, toxic nephropathy, hepatic
dysfunction including cholestasis, aplastic anemia,
hemolytic anemia, hemorrhage, and colitis.
Several cephalosporins have been implicated in
triggering seizures, particularly in patients with renal
impairment when the dosage was not reduced.
Gastric lavage may be indicated; otherwise, no specific
DOSAGE AND ADMINISTRATION:
Adults: the recommended dose of CEFIX is 400 mg
daily. This may be given as a 400 mg capsule daily or as
200 mg capsule every 12 hours.
For the treatment of uncomplicated (cervical/urethral)
gonococcal infections, a single oral dose of 400 mg is
Children: the recommended dose is 8 mg/kg/day of
the suspension, this may be administered as a single
daily dose or may be given in two divided doses, as 4
mg/kg every 12 hours.
In the treatment of infections due to S. pyogenes a
therapeutic dosage of CEFIX should be administered for
at least 10 days.
Dosage for impaired renal function:
Patients with creatinine clearance between 21 and 60ml/
min, the dosage should be reduced to (300 mg daily).
Patients with creatinine clearance < 20 ml/min, the
dosage should be reduced to (200 mg daily).
PACKAGING AND COMPOSITION:
CEFIX 200 mg Capsule : One Blister Containing 6
Each capsule contains Cefixime 200 mg.
CEFIX 400 mg Capsule : One Blister Containing 6
Each capsule contains Cefixime 400 mg.
CEFIX 100 mg Dry Syrup: Dry powder for oral suspension ,
bottle of 60 ml:
Each 5 ml of the reconstituted suspension contains:
Cefixime 100 mg.
Store at controlled room temperature 15 to 30° C.
Keep out of reach of children.
RECONSTITUTION FOR ORAL
Invert bottle and tab to loosen the powder. Add water,
until the reconstituted suspension is at level with the
mark on the bottle.
After reconstitution the suspension may be kept for 14
days either at room temperature, or under refrigeration,
without significant loss of potency. Keep tightly
closed. Shake well before using.