Cefixime Trihydrate
Indications
Cefixime is indicated in the treatment of
the following infections when caused by the susceptible strains of the
designated microorganisms:
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Pharmacology
Cefixime is a third generation
semisynthetic cephalosporin antibiotic for oral administration. It is
bactericidal against a broad spectrum of gram positive and gram negative
bacteria at easily achievable plasma concentrations. It kills bacteria
by interfering in the synthesis of bacterial cell wall. It is highly
stable in the presence of Beta-lactamase enzyme. As a result, many
organisms resistant to penicillins and some cephalsporins due to the
presence of beta-lactamases, may be susceptible to Cefixime. Absorption
of it is about 40% to 50% whether administered with or without food.
Dosage & Administration
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Interaction
Carbamazepine: Concomitant use elevates the
carbamazepine level. Warfarin and other anticoagulants: Concomitant use
increases prothrombin time.
Contraindications
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
Side Effects
The drug is generally well tolerated. The
most frequent side effects are diarrhoea and stool changes; that have
been more commonly associated with higher doses. Other side effects are
nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and
dizziness. Allergies in the form of rash, pruritus, urticaria, drug
fever and arthralgia have been reported. These reactions usually
subsided upon dicontinuation of therapy.
Pregnancy & Lactation
There are, however, no adequate and
well-controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be
used during pregnancy only if clearly needed. It is not known that
Cefixime is excreted in human milk. So, caution should be exercised when
Cefixime is administered to a nursing woman.
Precautions & Warnings
The drug should be prescribed with caution
in individuals with a history of gastrointestinal disease, particularly
colitis. The drug should be given with caution in patients with marked
impaired renal function as well as those undergoing continuous
ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is
only necessary in severe renal failure (creatinine clearance < 20
ml/min), in that case a dose of 200 mg once daily should not be
exceeded.
Overdose Effects
Gastric Lavage may be indicated; otherwise,
no specific antidote exists. Cefixime is not removed in significant
quantities from the circulation by hemodialysis or peritoneal dialysis.
Adverse reactions in small numbers of healthy adult volunteers receiving
single doses up to 2 g of Cefixime did not differ from the profile seen
in patients treated at the recommended doses.
Therapeutic Class
Third generation Cephalosporins
Storage Conditions
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.