CEFIM
(CEFIXIME)
Description:
Cefixime
is a semi synthetic, cephalosporin antibiotic for oral administration.
Cefim
200mg Capsule contains: Cefixime U.S.P. ......200mg.
Cefim
400mg Capsule contains: Cefixime U.S.P. .....400mg
Granules
for paediatric oral suspension:
Cefim
suspension:
Cefim
fine granules contain 100mg of Cefixime US.P in each 5 ml volume of
reconstituted strawberry-flavored suspension.
Cefim
DS suspension:
Cefim
fine granules contain 200mg of Cefixime USP in each 5 ml volume of
reconstituted strawberry-flavored suspension.
Clinical
Pharmacology:
Mode
Of Action:
Like
all beta-lactam antibiotics, cefixime binds to specific penicillin-binding
proteins (PBPs) located inside the bacterial cell wall, causing the inhibition
of the third and last stage of bacterial c…
Central
Nervous System:
Headache
and dizziness.
Hypersensitivity
Reactions:
Allergies
in the form of rash, pruritus, urticaria, drug fever and arthralgia have been
observed. These reactions usually subsided upon discontinuation of therapy.
Haematological
And Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been
reported. These reactions were infrequent and reversible. Mild transient
changes in liver and renal function tests have been observed.
Dosage
& Method Of Administration:
Absorption
of Cefixime is not significantly modified by the presence of food. The usual
course of treatment is 5 - 14 days.
Adults
And Children Over 12 Years:
The
recommended adult dosage is 400mg daily administered as a single dose.
Children
< 12 Years:
The
recommended dosage for children is 8mg/kg/day administered as a single dose. As
a general guide for prescribing in children, the following daily doses in terms
of volume of Paediatric Oral Suspension are suggested.
Children
1-4 Years: 100Mg Daily Children 5-9 Years: 200Mg Daily
Children
10-12 Years.: 300Mg Daily
The
dosage in children aged 6 months to one year should be calculated on mg/kg
basis. Children weighing more than 30kg or older than 12 years should be
treated with the recommended adult dose. The safety and efficacy of Cefixime
has not been established in children aged less than 6 months.
The
Elderly:
Elderly
patients may be given the same dose as recommended for adults. Renal function
should be assessed and dosage should be adjusted in severe renal impairment.
Dosage
in Renal Impairment:
Cefixime
may be administered in the presence of impaired renal function. Normal dose and
schedule may be given in patients with creatinine clearance of 20ml/min. or
greater. In patients whose creatinine clearance is less than 20ml/min. it is
recommended that a dose of 200mg once daily should not be exceeded. The dose
and regimen for patients who are maintained on chronic ambulatory peritoneal
dialysis or haemodialysis/should follow the same recommended.dose as that for
patients with creatinine clearance of less than 20ml/min.
Directions
For Reconstitution:
To
reconstitute add one measure full of water (previously boiled and cooled) to
the contents in the bottle, invert and shake to wet the powder. Then add a
further measure full of water and shake to make suspension. After
reconstitution, the suspension may be stored at room temperature for 7 days
without significant loss of potency. Do not freeze. Keep bottle tightly closed
and shake well before use. Discard any unused portion after 7 days. Dilution of
the suspension is not recommended.
Instructions:
Store
below 30°C.
Protect
from sunlight and moisture.
Keep
out of reach of children
Do
not freeze.
Presentation:
*
Cefim 200mg Capsules: Blister of 10 capsules.
*
Cefim 400mg Capsules: Blister of 5 capsules.
*
Cefim suspension: Powder for paediatric oral suspension (100mg/5ml on
reconstitution).
*
Powder for preparation of 30 ml suspension.
*
Powder for preparation of 60 ml suspension.
*
Cefim DS suspension: Powder for paediatric oral suspension (200mg/5ml on
reconstitution).
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