DESCRIPTION
ROXIM is a preparation of Cefxime, a third-generation cephalosporin
antibiotic for oral administration. Cefix me has marked in-vitro bactericidal
activity against a wide variety of Gram-positive & Gram-negative ve
organisms. Cefixime is also stable for hydrolysis by many beta-lactamases.
Cefixime has a longer duration of action than the other cephalosporins that
are active by mouth.
INDICATIONS
ROXIM’ is indicated for the treatment of following acute infections, when
caused by susceptible e microorganisms.
Upper respiratory tract infections
Otitis Media & other URTIS where the causative organism s known or
suspected to be resistant to other commonly used antibiotics, or where
treatment failure may carry significant risks.
Lower respiratory tract infections
e.g. Bronchitis.
Urinary tract infections
e.q. Cystitis. Cystourethrits. Pyelonephritis
Clinical efficacy has been demonstrated n infections caused by commonly
occurring pathogens incLuding Slreplococcus pneumonia, Streptococcus
pyogenes, E. coli, Proteus mirabilis, Klebsiella species, Haemophilus
influenzae (beta-laotamases posltive & negative), Alaraxella catarrhalis
(beta-lactamases postive & negatlve) & Erierehaclerspecies Ceix ae s
highly stab e in the presence of beta-lactamase enzymes
l\y’ost stra ns of Enterococci (Slreptococcus faecalis. group D Streptocacci)
& Staphylococci (including coagulase-positive & negative strains &
methicillin-resistant strains) are resistant to Cefxme in addition. most
strains of Pseudomonas, Clostridium, Bacteroids fragilis & Listetia
monacylogenes a’e.psislant to Cefixime.
DOSAGE & ADMINISTRATION
The usual treatment of Cefixime is 7 days. This may be continued for up to
14 days.
Adult & children over 10 years: 200-400 mg daily as a single dose
or in 2 divided doses.
Children over 6 months: 8 mg/kg/day as a single dose or in
2 divided doses.
Children 6 months-1 year: 75 mg daily
Children ‘l-4 years: 100 mg daily
Children 5-10 years: 200 mg daily
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalosporin n antibiotics; porphyria.
PRECAUTIONS
Cefixime should be prescribed with caution in individuals with a history of
gastrointestinal diseases, particularly costs. Dosage adjustment is only
necessary for severe renal failure (creatinine clearance < 20 mL/m n).
USE IN PREGNANCY & LACTATION
Suff c ent information is not available, so it is probably best to avoid using
the drug during pregnancy & lactating period.
SIDE-EFFECTS
Cefxme is generally well tolerated. The majority of adverse reactions
observed in clinical trials were mild & self-limiting in nature.
Gastrointestinal disturbances: Diarrhoea (lf severe diarrhea occurs,
Cefixime should be discontinued), and changes in the color of stool, nausea,
abdominal pain, dyspepsia, vomiting, and flatulence have been reported.
Central nervous system disturbances; Headache,  dizziness.
Others: Hypersensitivity reactions, which usually subsided upon
discount of therapy; infrequent & reverse changes. elevation of serum amylase.
PHARMACEUTICAL PRECAUTION
Capsule; Do not store above 30 oC temperature. Protect from moisture & light.
Powder for Suspension: Do not store above 25 C temperature. Protect
from mo store & light.
Keep out of the reach of children.
For accurate dosing of the suspension, please check the direction for
reconstitution and also the direction for the administration of suspension on
the opposite of this page.
PACKAGING
ROXIM”200Capsule: Box containing 2 strips of 8 capsules or 25 strips of 8
capsules each. Each capsule contains Cefixime Trihydrate
USP equivalent to Cefixime 200 mg in HPUC capsule shell
ROXIM- 400  I slip cf 10 capsuLes or 25 slips of 8
capsules each. Each capsule contains Cefixime Trihydrate
USP equivalent to Cefixime 400 mg in HPNy’C capsule shell.
ROXIM’S Powder for Bottle containing powder for the preparation of 30 mL
Suspension suspension. After reconstltutjon each 5 mL conlains
Cefixime Trihydrate USP equivalenl to Ceflxime 100 mg.
ROXIM’N4 Powder for Bottle containing ng powder for the preparation of 50 mL
Suspension. After reconstitution each 5 mL contains
Ceflx me Trihydrate USP equivalent lo Cefxime 100 mg.
ROXIM’L Powder for Bottie contains ng powder for the preparation of 75 mL
Suspension suspension. After reconstitution each 5 mL contains
Cefixime Trihydrate USP is equivalent to Cefixime 100 mg.
ROXIM’XL Powder for Bottle contains ng powder for the preparation of 60 ml suspension. After reconstitution each 5 mL contains
Cefixime Trihydrate USP is equivalent to Ceflxime 200 mg.
ROXIM Powder for Bottle containing powder for the preparation of 15 mL
Paediatric Drops suspension. After reconstitution each mL contains
Cefixime Trihydrate USP is equivalent to Ceflxime 25 mg.