CEFIGET Powder for suspension

Indications

- uncomplicated urinary tract infections

- otitis media

- pharyngitis, tonsillitis

- acute bronchitis, acute exacerbations of chronic bronchitis

- uncomplicated gonorrhea (cervical/urethral)

Dosage

Adults and children over 10 years: 200-400mg daily according to the severity of infection, given 1-2 time(s) daily.

Children: 8mg/kg/day, 1-2 time(s) daily. 4mg/kg every 12 hours except for urinary tract infection where once daily dosing must be used.

6 months -1 year:3.75mL

1-4 years: 5mL daily

5-10 years: 10mL daily

Children weighing more than 50k or older than 10 years should be treated with the recommended adult dose.

Otitis Media: should be treated with the suspension.

Duration of Therapy

The usual course of treatment is 7 days. This may be continued for up to14 days if required.

In the treatment of infections due to S.pyogenes, a therapeutic dosage should be administered for at least 10 days.

Special Populations

Renal Insufficiency

This medicine may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20mL/min or greater. In patients who se creatinine clearance is less than 20mL/min, it is recommended that a dose of 200mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis of hemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20mL/min.

Directions for Preparing Oral Suspension

Fill previously boiled and cooled water up to the line mark on the bottle and shake vigorously.

The reconstituted suspension can be used for up to 7 days, when stored at room temperature and up to 14 days when refrigerated without significant loss of potency. Keep tightly closed. Shake well before using.

Discard unused portion after 14 days.

Patients with hypersensitivity to any coponent of this medicine, patients with known allergy to cephalosporins group, and children less than six months.

Gastrointestinal disturbance: Diarrhea (if severe diarrhea occurs, cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence, Pseudomembranous colitis.

Central nervous system disturbance: Headache, dizziness, seizures.

Hepatic Disorders: Transient rises in liver transaminases, alkaline phosphatase, jaundice.

Others: Hypersensitivity reactions which usually subside upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase. Increase in prothrombin time. Genital pruritis, vaginitis.

Anticoagulants: Care should be exercised in patients receiving anticoagulants and cefixime concomitantly due to the possibility that cefixime may increase prothrombin time.

Carbamazepine: Elevated carbamazepine levels have been reported, when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Laboratory Interactions

- A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.

- A false-positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

- A false-positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognized that a positive Coombs test may be due to the drug.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Cefixime should not be used in pregnancy unless considered essential by the physician.

Nursing mothers

It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

- Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.

- Cefixime should be administered with caution in patients with markedly impaired renal function.

- Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.

- Broad-spectrum antibiotics such as cefixime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

- Do not use cefixime to treat S.aureus as this strain of staphylococci is resistant to cefixime.

It has bactericidal activity of gram poditive and gram negative . like other cepholosporins, cefixime exhibits its bactericidal action by binding to specific penicillin-binding proteins located inside the bacteriaｌ cell wall, causing the inhibition of the third and last stage of bacteria cell wall autolytic enzyme such as autolysins. The antibacterial effect results from inhibition of mucopeptide synthesis in the bacterial cell wall.