FIX-A

CEFIXIME TRIHYDRATE

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.

Third generation Cephalosporinsa

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.

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 8-1 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. Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

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.

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.

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.

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.

Keep below 308C temperature, protected from light & moisture. Keep out of the reach of children.