Prescription Drug Information: Cefuroxime Axetil

CEFUROXIME AXETIL- cefuroxime axetil tablet
Golden State Medical Supply, Inc.

1 INDICATIONS AND USAGE

1.1 Pharyngitis/Tonsillitis

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.

Limitations of Use

  • The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials.
  • The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.

1.2 Acute Bacterial Otitis Media

Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae , Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes.

1.3 Acute Bacterial Maxillary Sinusitis

Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only).

Limitations of Use

The effectiveness of cefuroxime axetil for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see CLINICAL STUDIES ( 14.1)] .

1.4 Acute Bacterial Exacerbations of Chronic Bronchitis

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae , Haemophilus influenzae (β-lactamase–negative strains), or Haemophilus parainfluenzae (β-lactamase–negative strains).

1.5 Uncomplicated Skin and Skin-Structure Infections

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β - lactamase–producing strains) or Streptococcus pyogenes.

1.6 Uncomplicated Urinary Tract Infections

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.

1.7 Uncomplicated Gonorrhea

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase producing and non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae.

1.8 Early Lyme Disease (erythema migrans)

Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.

1.10 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see CLINICAL PHARMACOLOGY ( 12.3)] .
  • Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see DOSAGE AND ADMINISTRATION ( 2.2)].
  • Administer cefuroxime axetil tablets with or without food.
  • Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see DOSAGE AND ADMINISTRATION ( 2.2)].

2.2 Dosage for Cefuroxime Axetil Tablets

Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food.

Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets
*
The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.
When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.
Infection Dosage Duration ( Days )
Adults and Adolescents ( 13 years and older )
Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10
Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10
Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10 *
Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10
Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10
Uncomplicated gonorrhea 1,000 mg single dose
Early Lyme disease 500 mg every 12 hours 20
Pediatric Patients younger than 13 years ( who can swallow tablets whole )
Acute bacterial otitis media 250 mg every 12 hours 10
Acute bacterial maxillary sinusitis 250 mg every 12 hours 10

2.5 Dosage in Patients with Impaired Renal Function

A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY ( 12.3)].

Table 4. Dosing in Adults with Renal Impairment
Creatinine Clearance ( mL / min ) Recommended Dosage
≥30 No dosage adjustment
10 to ˂30 Standard individual dose given every 24 hours
˂10 (without hemodialysis) Standard individual dose given every 48 hours
Hemodialysis A single additional standard dose should be given at the end of each dialysis
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