We are also manufacturing Cefixime + Ofloxacin in Dry Syrup form.
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Cefixime Trihydrate is an oral third generation cephalosporin antibiotic used to treat infections caused
by bacteria such as pneumonia; bronchitis; gonorrhea; and ear, lung, throat, and urinary tract
infections.Cefixime is used to treat many different types of infections caused by bacteria.
Cefixime may also be used for other purposes not listed in this medication guide.
Ofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class
considered to be a second-generation fluoroquinolone.
● Typhoid Fever
● Urinary Tract Infection
● Respiratory Tract Infection
● Nosocomial Infections
● Soft Tissue Infections
● Surgical Prophylaxis
● Intra-abdominal Infections.
Rationale Of Combination:
● Unique Dual Mode Of Action
● Ofloxacin-Prevents nucleic acid synthesis
● Cefixime-Inhibits cell wall synthesis
● Acts synergetically
● Gives better patient compliance.
About 40% to 50% is absorbed. C maxfollowing 200 and 400 mg doses of oral suspension are 3
and 4.6 mcg/mL, respectively. T max occurs between 2 and 6 h following administration of 400
mg and between 2 and 5 h after a 200 mg dose.
Protein binding is about 65%.
About 50% of absorbed dose is excreted unchanged in the urine in 24 h. Serum t ½averages 3
to 4 h, but may be as long as 9 h in some healthy subjects.
Following oral administration, the bioavailability of ofloxacin in the tablet formulation is
approximately 98%. Maximum serum concentrations are achieved one to two hours after an oral
Elimination is mainly by renal excretion. Between 65% and 80% of an administered oral dose of
ofloxacin is excreted unchanged via the kidneys within 48 hours of dosing. Four to eight percent
of an ofloxacin dose is excreted in the feces. This indicates a small degree of biliary excretion of
Mechanism of Action:
This tablet is one of the combination of cefixime (cephalosporin) and ofloxacin (fluoroquinolone)
and has unique dual mode of action i.e in this combination ofloxacin prevents nucleic
acid synthesis of bacteria and cefixime inhibits bacterial cell wall synthesis.It is useful for
killing thr ESBL (Extended Spectrum Beta-lactamase) bacteria.Both works instantly and
synergistically and gives better patient compliance. Cefixime is an antibiotic, is a third
generation cephalosporin like ceftriaxone and Cefotaxime.Cefixime is highly stable in the
presence of beta lactamases enzymes.Cefixime is an effective treatment to stop the spread of
several bacterial infections. It is often used as a treatment for gonorrhea, pharyngitis, typhoid
fever and tonsillitis.ofloxacin belongs to fluoroquinolones group of antimicrobials i.e.-These are
the quinolones having one or more fluorine substitution in their structure.Ofloxacin used to treat
pneumonia and bronchitis caused by H.influenzae and S.pneumoniae.It is also used in treating
skin infections caused by staphylococcus aureus and streptococcus pyogenes bacteria.
Adverse Drug Reaction:
Most of adverse reactions observed in clinical trials were of a mild and transient nature.
The most commonly seen adverse reaction in a clinical trials of the tablet formulation were
gastrointestinal and also adverse reaction have been reported for cephalosporin sensitive
person and also in some cases nasopharyngitis, fatigue, dry mouth and pharyngitis and most
were mild to moderate in intensity.
This tablet is contraindicated In patients with known hypersensitivity to the cephalosporin or
penicillin or fluoroquinolone antibiotics.
Elevated carbamazepine levels have been reported when tablet is administrated concomitantly
with carbamazepine salt and with warfarin and anticoagulantsdrugs, the prothrombin time is
increased when this tablet is administrated concomitantly. Ofloxacin from chelates with alkaline
earth and transition metal cations when administrated with antacids containing calcium,
magnesium or aluminium, with sucralphate, with divalent or trivalent cations such as iron, or
with multivitamins containing zinc. Elevated serum levels of cyclosporine have been reported
with concomitant use of cyclosporine with some other quinolones.
● Prescribing Ofloxacin & Cefixime in the absence of proven or strongly suspected
bacterial infection or a prophylactic indication is unlikely to provide benet to the patient
and increase the risk of the development of drug resistant bacteria.
● Adequate hydration of patients receiving ofloxacin should be maintained to preent the
formation of highly concentrated urine.
● Administer ofloxacin with caution in the presence of renel or heptic impairment. In
patients with known or suspected renel or heptic impairment, careful clinical observation
and appropriate laboratory studies should be performed prior to and during therapy since
elimination of ofloxacin may be reduced.
● 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 super infection occurs during therapy,
appropriate measures should be taken. The dose of cefixime should be adjusted in
patients with renel impairment as well as those undergoing continuous ambulatory
peritoneal dialysis (CAPD) and hemodialysis (HD).
● Patient on dialysis should be monitored carefully. Cefexime should be prescribed with
caution In individuals with a history of gastrointestinal dsease, particularly colitis.