SPECTRACEF® (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including β-lactamase-producing strains).

Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including β-lactamase producing strains).

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: SPECTRACEF® is effective in the eradication of Streptococcus pyogenes from the oropharynx. SPECTRACEF® has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including β-lactamase-producing strains) or Streptococcus pyogenes.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be used only to treat 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.

(See INDICATIONS AND USAGE for Indicated Pathogens.)

SPECTRACEF® (cefditoren pivoxil) Dosage and Administration* Adults and Adolescents ( ≥ 12 Years)

Patients with Renal Insufficiency

No dose adjustment is necessary for patients with mild renal impairment (CLcr: 50-80 mL/min/1.73 m²). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (CLcr: 30-49 mL/min/1.73 m²) and 200 mg QD be administered to patients with severe renal impairment (CLcr: < 30 mL/min/1.73 m²). The appropriate dose in patients with end-stage renal disease has not been determined.

Patients with Hepatic Disease

No dose adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). The pharmacokinetics of cefditoren have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).

SPECTRACEF® (cefditoren pivoxil) tablets containing cefditoren pivoxil equivalent to 200 mg or 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 200” or “CBP 400” in blue. These tablets are available in a multi-dose tamper-evident container, or as the 1-count blister package (Physician Sample), as follows:

NDC 10122-802-60: 400 mg 60 count bottles. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.

NDC 10122-802-20: 400 mg 20 count bottles. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.

NDC 10122-802-02: 400 mg 1 count blister. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.

NDC 10122-801-60: 200 mg 60 count bottles. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 200 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 200” in blue.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Healthcare professionals can telephone Aristos Pharmaceuticals Information Line (1-866-280-5755) for information on this product.

REFERENCES

2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22nd Informational Supplement. CLSI document M100-S22, 2012.

Manufactured by: Tedec-Meiji Farma, S.A Madrid, Spain. Distributed by: Cornerstone Therapeutics Inc. Cary, NC 27518

Last reviewed on RxList: 8/17/2012
This monograph has been modified to include the generic and brand name in many instances.