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Cefixime is 3rd generation oral cephalosporin.
INDICATIONS
To reduce the development of drug resistant bacteria and maintain the effectiveness of Halixim (cefixime) for Oral Suspension and other antibacterial drugs, Halixim should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Halixim is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
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 S. pyogenes*.
Note: For information on otitis media caused by Streptococcus pneumoniae, see CLINICAL STUDIES section.
Pharyngitis and Tonsillitis, caused by S. pyogenes.
Note: Penicillin is the usual drug of choice in the treatment of S. pyogenes infections, including the prophylaxis of rheumatic fever. Halixim is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Halixim in the subsequent prevention of rheumatic fever are not available.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).
Appropriate cultures and susceptibility studies should be performed to determine the causative organism and its susceptibility to cefixime; however, therapy may be started while awaiting the results of these studies. Therapy should be adjusted, if necessary, once these results are known.
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
DOSAGE AND ADMINISTRATION
Adults: Once Halixim is reconstituted, the recommended dose of the suspension is 400 mg daily. 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.
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PEDIATRIC DOSAGE CHART
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Patient Weight
(kg)
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Dose/Day
mg
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Dose/Day
mL
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Dose/Day
tsp of suspension
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6.25
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50
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2.5
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½
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12.5
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100
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5
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1
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18.75
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150
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7.5
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1½
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25
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200
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10
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2
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31.25
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250
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12.5
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2½
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37.5
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300
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15
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3
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Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Otitis media should be treated with the suspension. Clinical studies of otitis media were conducted with the suspension, and the suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media. (See CLINICAL PHARMACOLOGY.)
Efficacy and safety in infants aged less than six months have not been established.
In the treatment of infections due to S. pyogenes, a therapeutic dosage of Halixim should be administered for at least 10 days.
Renal Impairment
Halixim may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
Reconstitution Directions For Oral Suspension
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Bottle Size
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Reconstitution Directions
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100 mL
100 mg/5 mL
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To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
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75 mL
100 mg/5 mL
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To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
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50 mL
100 mg/5 mL
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To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
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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. Discard unused portion after 14 days.
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