CEFIX (CAPSULES / DRY POWDER FOR ORAL SUSPENSION)
Cefixime

DESCRIPTION:
CEFIX (cefixime) is a semisynthetic, cephalosporin antibiotic for oral administration.
CEFIX is available in powder for oral suspension in a dose 100 mg /5 ml , 200 mg and 400 mg capsules.
 

CLINICAL PHARMACOLOGY:
CEFIX, given orally, is about 40% to 50% absorbed whether administered with or without food.
Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg capsule , a single 400 mg capsule.
Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours.
The serum half-life of cefixime in healthy subjects is independent of dosage from and averages 3 to 4 hours, but may range up to 9 hours in some normal volunteers.
In subjects with moderate impairment of renal function (20 to 40 ml/min creatinine clearance), the average serum half-life of cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 ml/min creatinine clearance) the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis.
Adequate data on CSF levels of CEFIX are not available.
 

Microbiology:
As with other cephalosporins, bactericidal action of CEFIX results from inhibition of cell-wall synthesis.
CEFIX is highly stable in the presence of beta-lactamase enzymes.
As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamase, may be susceptible to CEFIX.
CEFIX has been shown to be active against most strains of the following organisms.
Gram-positive organisms:
- Streptococcus pneumoniae.
- Streptococcus pyogenes.
Gram-negative organisms:
Haemophilus influenzae (beta-lactamase positive and negative strains), moraxella (branhamella) catarrhalis (most of which are beta-lactamase positive), escherichia coli, proteus mirabilis, neisseria gonorrhoeae (including penicillinase- and non- penicillinase-producing strains).
Note: pseudomonas species, strains of group D streptococci (including enterococci), Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains) and most strains of enterobacter are resistant to cefixime. In addition, most strains of bacteroides fragilis and clostridia are resistant to CEFIX.
 

INDICATIONS AND USAGE:
CEFIX (cefixime) is indicated in the treatment of the following infections:
Uncomplicated urinary tract infections: caused by Escherichia coli and proteus mirabilis.
Otitis media: Caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive) and Streptococcus pyogenes.
Pharyngitis and tonsillitis: Caused by S. pyogenes.
CEFIX is generally effective in the eradication of S. pyogenes from the nasopharynx.
Acute bronchitis and acute exacerbations of chronic bronchitis: Caused by S. pneumoniae and H. influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral): Caused by Neisseria gonorrhoeae (penicillinase- and non–penicillinase-producing strains).
 

CONTRAINDICATIONS:
CEFIX is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS:
Before therapy with CEFIX is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.
If an allergic reaction to CEFIX occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluid, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Treatment with broad-spectrum antibiotics, including CEFIX, alters the normal flora of the colon and may permit overgrowth of clostridia.
 

RECAUTIONS:
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 superinfection occurs during therapy, appropriate measures should be taken.
The dose of CEFIX should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully.
CEFIX should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
 

DRUG INTERACTIONS
Carbamazepine: elevated carbamazepine levels have been reported in experience when CEFIX is administered concomitantly.
Pregnancy category B: It has revealed no evidence of harm to the fetus due to CEFIX. There are no adequate and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if clearly needed.
Nursing mothers: It is not known weather CEFIX is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug..
Pediatric use: Safety and effectiveness of CEFIX in children aged less than 6 months old have not been established.
 

ADVERSE REACTIONS:
Most of the adverse reactions observed in clinical trials were of a mild and transient nature.
The most commonly seen adverse reactions were:
Gastrointestinal events: Individual event rates included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7% dyspepsia 3%, and flatulence 4%.
These symptoms usually responded to symptomatic therapy or ceased when CEFIX was discontinued.
Hypersensitivity reactions: skin rashes, urticaria, drug fever, and pruritus. Erythema multiform.
Stevens-Johnson syndrom, and serum sickness-like reactions have been reported.
Hepatic: transient elevations in SGPT, SGOT, and alkaline phosphatase.
Renal: transient elevations in BUN or creatinine.
Central nervous system: Headaches or dizziness.
Hemic and lymphatic system: transient thrombocytopenia, leukopenia, and eosinophilia, prolongation in prothrombin time was seen rarely.
Other: genital pruritus, vaginitis, candidiasis.
Renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced.
 

OVERDOSAGE:
Gastric lavage may be indicated; otherwise, no specific antidote exists.
DOSAGE AND ADMINISTRATION:
Adults: the recommended dose of CEFIX is 400 mg daily. This may be given as a 400 mg capsule daily or as 200 mg capsule every 12 hours.
For the treatment of uncomplicated (cervical/urethral) gonococcal infections, a single oral dose of 400 mg is recommended.
Children: the recommended dose is 8 mg/kg/day of the suspension, this may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
In the treatment of infections due to S. pyogenes a therapeutic dosage of CEFIX should be administered for at least 10 days.
Dosage for impaired renal function:
Patients with creatinine clearance between 21 and 60ml/ min, the dosage should be reduced to (300 mg daily).
Patients with creatinine clearance < 20 ml/min, the dosage should be reduced to (200 mg daily).
 

PACKAGING AND COMPOSITION:
CEFIX 200 mg Capsule : One Blister Containing 6 capsules:
Each capsule contains Cefixime 200 mg.
CEFIX 400 mg Capsule : One Blister Containing 6 capsules:
Each capsule contains Cefixime 400 mg.
CEFIX 100 mg Dry Syrup: Dry powder for oral suspension , bottle of 60 ml:
Each 5 ml of the reconstituted suspension contains: Cefixime 100 mg.
 

STORAGE:
Store at controlled room temperature 15 to 30° C.
Keep out of reach of children.
 

RECONSTITUTION FOR ORAL SUSPENSION:
Invert bottle and tab to loosen the powder. Add water, until the reconstituted suspension is at level with the mark on the bottle.
After reconstitution the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using.