Cefixime Trihydrate BP

To be submitted at the time of inclusion.

Capsule
Each Capsule contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.

It is indicated for the treatment of the following acute infections, when caused by susceptible microorganisms. Upper respiratory tract infections e.g. Otitis media and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics or where treatment failure may carry significant risk.

Lower respiratory tract infections e.g. Bronchitis.

Urinary tract infections e.g. cystitis, cystourethritis, pyelonephritis.

Clinical efficacy has been demonstrated in infections caused by commonly occuring pathogens including Streptococcus pneumoniae, Streptococccus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), and Enterobacter species, Cefixime is highly stable in the presence of beta-lactamase enzymes.

Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains methecillin- resistant strains) are resistant to cefixime. Inaddition, most strains of Pseudomonas, Clostridia, Bacteroides fragilis, and Listeria monocytogenes are resistant to cefixime.

The usual treatment of cefixime is 7 days. This may be continued for up to 14 days.
Adult and child over 10 years : 200-400 mg daily as a single dose or in 2 divided dose.
Child over 6 months : 8 mg/kg daily as a single dose or in 2 divided dose.
Child over 6 months - 1 year : 75 mg daily.
Child 1-4 years : 100 mg daily.
child 5-10 years : 200 mg daily.

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limited in nature. Gastrointestinal disturbance: Diarrhoea (if severe diarrhoea occurs, cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported.

Central nervous system disturbance: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

Cefixime should be prescribed with caution in individuals with history of gasrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (Creatinine clearance < 20 ml/min)

Patients with known hypersensitivity to cephalosporin antibiotic, porphyria.

Absorption reduced in presence of food, antacid and ergot alkaloids. Increase plasma concentration of digoxin and cyclosporine.

• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.

To be submitted at the time of inclusion.