Source: FDA, National Drug Code (US) Revision Year: 2013
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):
| Type of Infection | Dosage | Duration (Days) |
|---|---|---|
| Community-Acquired Pneumonia | 400 mg BID | 14 |
| Acute Bacterial Exacerbation of Chronic Bronchitis | 400 mg BID | 10 |
| Pharyngitis/Tonsillitis | 200mg BID | |
| Uncomplicated Skin and Skin Structure Infections |
* Should be taken with meals
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.
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).
Information on cefditoren pivoxil overdosage in humans is not available. However, with other β-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of cefditoren from the body, particularly if renal function is compromised (30% reduction of plasma concentrations following 4 hours of hemodialysis). Treat overdosage symptomatically and institute supportive measures as required.
In acute animal toxicity studies, cefditoren pivoxil when tested at the limit oral doses of 5100 mg/kg in rats and up to 2000 mg/kg in dogs did not exhibit any health effects of concern. Certain effects, such as diarrhea and soft stool lasting for a few days were observed in some animals as expected with most oral antibiotics due to inhibition of intestinal microflora.
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 the Medical Information Line (1-866-290-0698) for information on this product.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
