Gracefix

Each 5 mL of reconstituted suspension contains: Cefixime trihydrate equivalent to cefixime 100 mg.

Treatment of infections due to sensitive gram-positive and gram-negative bacteria.
Microorganisms: Streptococcus sp, Neisseria gonorrhoeae, Moraxella catarrhalis, Klebsiella sp, Proteus sp, Morganella morganii, Haemophilus parainfluenzae, Shigella sp, Pasteurella multocida, Citrobacter amalonaticus, Enterobacter sp, Yersinia enterocolitica, Streptococcus pneumoniae, Neisseria meningitidis, Escherichia coli, Serratia sp, Providencia sp, Haemophilus influenzae, Salmonella sp, Aeromonas hydrophila, Citrobacter freundii, Citrobacter diversus, Acinetobacter lwoffii and Campylobacter jejuni.
Infections: Respiratory Tract Infections: Upper and lower airways infection, pulmonary infections of bacterial etiology, bronchitis (acute, chronic), pneumonia, bronchiectasis with infection, secondary infections in chronic respiratory diseases.
Ear, Nose and Throat Infections: Otitis media, tonsillitis, laryngitis, sinusitis, pharyngitis.
Gastrointestinal Infections: Typhoid.
Urinary Tract Infections: Infections of the kidneys and efferent urinary tract, complicated and uncomplicated urinary tract infections except for prostatitis, pyelonephritis, cystitis, gonococcal urethritis, uncomplicated gonorrhea (cervical/urethral).
Biliary Tract Infections: Infections of the biliary tract, cholecystitis and cholangitis.

Usual Course of Treatment: 5-14 days.
Adults and Children >12 years: Recommended Dose: 400 mg daily as single dose.
Children <12 years: Recommended Dose: 8 mg/kg/day as a single daily dose or may be given in 2 divided doses.
As a general guide for prescribing in children, the following daily doses are suggested: Children 10-12 years: 15 mL daily; 5-9 years: 10 mL daily; 1-4 years: 5 mL daily.
Infants 6 months-1 year: 3.37 mL daily.
The dosage in children 6 months-1 year should be calculated on mg/kg basis. The safety and efficacy of cefixime has been established in children <6 months.
Elderly: Elderly may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.
Renal Impairment: Cefixime may be adjusted in the presence of impaired renal function. Normal dose and frequency may be given in patients with creatinine clearance (CrCl) of ≥20 mL/min. It is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or hemodialysis should follow the same recommendation as that for patients with CrCl <20 mL/min.

Cefixime is contraindicated in patients with known allergy to the cephalosporins group of antibiotics.
Cefixime should be given with caution to patients with renal impairment, a dosage reduction may be necessary. Renal and hematological status should be monitored especially during prolonged and high-dose therapy.

Care is also necessary in patients with history of allergy.
Cefixime should be given with caution to patients with renal impairment, dosage reduction may be necessary. Cefixime may interfere with the Jaffe's method of measuring creatinine concentrations and may produce falsely high values; this should be borne in mind when measuring renal functions. Positive results to the direct Coombs' test have been found during treatment with cefixime and these can be interfering with blood cross matching. The urine of patients being treated with cefixime may give false reaction for glucose using copper reduction reactions.
Use in pregnancy: The safety of cefixime in the treatment of infection in pregnant women has not been established. Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefixime. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the likely benefits of using cefixime outweighs the potential risk to the fetus and/or the mother.

Use in pregnancy: The safety of cefixime in the treatment of infection in pregnant women has not been established. Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefixime. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the likely benefits of using cefixime outweighs the potential risk to the fetus and/or the mother.

The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum-sickness and anaphylaxis. The most frequent reported adverse effects of cefixime are gastrointestinal disturbances, especially diarrhea. Cefixime should be discontinued if diarrhea is severe.
Although cefixime does not have the N-methylthiotetrazole side chain usually associated with hypoprothrombinemia, increase in prothrombin times have occurred in a few patients.

Store at temperatures not exceeding 30°C. Protect from light and moisture.

Cephalosporins

J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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