Usual Adult Dose for Urinary Tract Infection

400 mg orally once a day OR 200 mg orally every 12 hours

Use: Treatment of patients with uncomplicated urinary tract infections caused by susceptible isolated of Escherichia coli and Proteus mirabilis

Usual Adult Dose for Otitis Media

Chewable tablets/oral suspension: 400 mg orally once a day OR 200 mg orally every 12 hours
Duration of therapy:

• Streptococcus pyogenes infections: 10 days

Comments:

• Chewable tablets or oral suspensions should be used for this indication.
• Efficacy for S pyogenes was studied in fewer than 10 patients.
• The overall response in the treatment of otitis media caused by Streptococcus pneumoniae was approximately 10% lower than in the comparator drug.

Use: Treatment of otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and S pyogenes

Usual Adult Dose for Tonsillitis/Pharyngitis

Chewable tablets/oral suspension: 400 mg orally once a day OR 200 mg orally every 12 hours

• Duration of therapy: 10 days

Comments:

• Penicillin is usually the drug of choice for the treatment of S pyogenes infections; however, this drug is effective in eradication of S pyogenes from the nasopharynx.
• There are no data on the efficacy of this drug in the prevention of rheumatic fever.

Use: Treatment of pharyngitis and tonsillitis caused by susceptible isolates of S pyogenes

Usual Adult Dose for Gonococcal Infection - Uncomplicated

400 mg orally ONCE

Comment: The dose may be given as a capsule or tablet.

Use: Treatment of uncomplicated cervical/urethral gonorrhea caused by susceptible isolated of penicillinase-/non-penicillinase-producing Neisseria gonorrhoeae

US Centers for Disease Control and Prevention (US CDC) Recommendations:
Uncomplicated anorectal or urogenital gonococcal infections in adolescents: 400 mg orally ONCE plus azithromycin

Use: Alternative regimen for the treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum caused by N gonorrhoeae when ceftriaxone is not available

Usual Pediatric Dose for Otitis Media

6 months to 12 years:
Chewable tablets/oral suspension:

• Children 45 kg or less: 8 mg/kg orally once a day OR 4 mg/kg every 12 hours
• Children over 45 kg: 400 mg orally once a day OR 200 mg orally every 12 hours

Over 12 years: 400 mg orally once a day OR 200 mg orally every 12 hours

Duration of therapy:

• S pyogenes infections: 10 days

Comments:

• Chewable tablets or oral suspensions should be used in this patient population.
• Efficacy for S pyogenes was studied in fewer than 10 patients.
• The overall response in the treatment of otitis media caused by S pneumoniae was approximately 10% lower than in the comparator drug.

Use: Treatment of otitis media caused by susceptible isolates of H influenzae, M catarrhalis, and S pyogenes

Usual Pediatric Dose for Urinary Tract Infection

6 months to 12 years:

• Children 45 kg or less: 8 mg/kg orally once a day OR 4 mg/kg every 12 hours
• Children over 45 kg: 400 mg orally once a day OR 200 mg orally every 12 hours

Over 12 years: 400 mg orally once a day OR 200 mg orally every 12 hours

Use: Treatment of patients with uncomplicated urinary tract infections caused by susceptible isolated of E coli and P mirabilis

Usual Pediatric Dose for Tonsillitis/Pharyngitis

6 months to 12 years:

• Children 45 kg or less: 8 mg/kg orally once a day OR 4 mg/kg every 12 hours
• Children over 45 kg: 400 mg orally once a day OR 200 mg orally every 12 hours

Over 12 years: 400 mg orally once a day OR 200 mg orally every 12 hours

Comments:

• Penicillin is usually the drug of choice for the treatment of S pyogenes infections; however, this drug is effective in eradication of nasopharynx infections.
• There are no data on the efficacy of this drug in the prevention of rheumatic fever.

Use: Treatment of pharyngitis and tonsillitis caused by susceptible isolates of S pyogenes

Infectious Diseases Society of America (IDSA) Recommendations:
Rhinosinusitis: 4 mg/kg orally 2 times a day PLUS clindamycin

• Duration of therapy: 10 to 14 days

Uses:

• Second-line adjunctive empiric treatment (with clindamycin) of acute bacterial rhinosinusitis (ABRS) in patients with a history of non-type-1 hypersensitivity to penicillin
• Second-line initial empiric treatment for ABRS in patients from geographic regions with high endemic rates of penicillin nonsusceptible S pneumoniae
• Second-line initial empiric treatment for ABRS in patients at risk for antibiotic resistance OR failed initial therapy

Usual Pediatric Dose for Bronchitis

6 months to 12 years:

• Children 45 kg or less: 8 mg/kg orally once a day OR 4 mg/kg every 12 hours
• Children over 45 kg: 400 mg orally once a day OR 200 mg orally every 12 hours

Over 12 years: 400 mg orally once a day OR 200 mg orally every 12 hours

Use: Acute exacerbations of chronic bronchitis caused by susceptible isolates of S pneumoniae and H influenzae

Usual Pediatric Dose for Gonococcal Infection - Uncomplicated

Uncomplicated cervical/urethral gonococcal infections:
6 months to 12 years:

• Children 45 kg or less: 8 mg/kg orally ONCE
• Children greater than 45 kg: 400 mg orally ONCE

Over 12 years: 400 mg orally ONCE

Comment: The dose in children over 45 kg OR those over 12 years may be given as a capsule or tablet.

Use: Treatment of uncomplicated cervical/urethral gonorrhea caused by susceptible isolated of penicillinase-/non-penicillinase-producing N gonorrhoeae

CDC recommendations:
Uncomplicated anorectal or urogenital gonococcal infections in adolescents: 400 mg orally ONCE plus azithromycin

Use: Alternative regimen for the treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum caused by N gonorrhoeae when ceftriaxone is not available

Usual Pediatric Dose for Bacterial Infection

American Academy of Pediatrics (AAP) Recommendations:
Pediatric patients beyond the newborn period: 8 mg/kg orally per day, given in 1 to 2 divided doses

• Maximum dose: 400 mg/day

Comment: This drug has inadequate activity against penicillin-resistant pneumococci.

Renal Dose Adjustments

Adults:
CrCl 21 to 59 mL/min:
Chewable tablets/tablets: Not recommended.
Oral suspension (preferred concentrations are 200 mg/5 mL or 500 mg/5 mL): 260 mg orally once a day

CrCl 20 mL/min or less:
100 mg/5 mL oral suspension: 172 mg orally once a day
200 mg/5 mL oral suspension: 176 mg orally once a day
500 mg/5 mL oral suspension: 180 mg orally once a day
Chewable tablets/tablets: 200 mg orally once a day

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known allergy to the active component, other cephalosporins, or to any of the ingredients

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Adults:
Renal hemodialysis:
Oral suspension (preferred concentrations are 200 mg/5 mL or 500 mg/5 mL): 260 mg orally once a day
Chewable tablets/tablets: Not recommended.

Continuous peritoneal dialysis:
100 mg/5 mL oral suspension: 172 mg orally once a day
200 mg/5 mL oral suspension: 176 mg orally once a day
500 mg/5 mL oral suspension: 180 mg orally once a day
Chewable tablets/tablets: 200 mg orally once a day

Comment: Hemodialysis and peritoneal dialysis does not remove significant amounts of drug from the body.

Other Comments

Administration advice:

• This drug may be taken without regard to food.
• Oral suspension: Shake well prior to administration.

Storage requirements:

• Oral suspension: Keep tightly closed; store reconstituted solution for up to 14 days, then discard unused portion after 14 days.

General:

• There was a lack of bioequivalence between oral suspension and tablet formulations in adult patients. Providers should consider bioequivalence when selecting formulations and should avoid using tablet formulations when treating otitis media in children.
• Local epidemiological and susceptibility patterns should be used to guide treatment selection in the absence of patient-specific culture and susceptibility information.
• Spectrum of Activity: This drug has shown activity in vitro and in clinical infections including Branhamella catarrhalis (beta-lactamase positive/negative), Enterobacter species, Escherichia coli, Haemophilus influenzae (beta-lactamase positive/negative), Klebsiella species, Proteus mirabilis, Streptococcus pneumoniae, Streptococcus pyogenes, and in the presence of beta-lactamase enzymes.
• Limitations of use: Many of the following strains have been found to be resistant to this drug: Bacteroides fragilis, Clostridia, enterococci (Streptococcus faecalis, group D streptococci), Listeria monocytogenes, Pseudomonas, staphylococci (e.g., coagulase-positive/-negative strains, methicillin-resistant strains).

Patient advice:

• Inform patients that this drug may cause confusion, convulsion, impairment in consciousness, movement disorders, and/or other side effects related to encephalitis, and they should avoid driving or operating machinery if these side effects occur.
• Patients should be directed to take the full course of treatment, even if they feel better.
• Patients should be instructed to report signs/symptoms of Clostridium difficile (e.g., watery/bloody stools, stomach cramps, fever), for up to 2 months after stopping treatment.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• Is there a gonorrhea treatment available over the counter?