Usual Adult Dose for Bronchitis

Acute bacterial exacerbation of chronic bronchitis: 400 mg orally twice a day for 10 days

Usual Adult Dose for Pneumonia

Community-acquired: 400 mg orally twice a day for 14 days

Usual Adult Dose for Tonsillitis/Pharyngitis

200 mg orally twice a day for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection

Uncomplicated: 200 mg orally twice a day for 10 days

Usual Pediatric Dose for Bronchitis

12 years or older:
Acute bacterial exacerbation of chronic bronchitis: 400 mg orally twice a day for 10 days

Usual Pediatric Dose for Pneumonia

12 years or older:
Community-acquired: 400 mg orally twice a day for 14 days

Usual Pediatric Dose for Tonsillitis/Pharyngitis

12 years or older: 200 mg orally twice a day for 10 days

Usual Pediatric Dose for Skin and Structure Infection

12 years or older:
Uncomplicated: 200 mg orally twice a day for 10 days

Renal Dose Adjustments

CrCl 30 to 49 mL/min: Not more than 200 mg orally twice a day
CrCl less than 30 mL/min: 200 mg orally once a day
End-stage renal disease: Data not available

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh Class A or B): No adjustment recommended.
Severe hepatic impairment (Child-Pugh Class C): Data not available

Precautions

Cefditoren is contraindicated in patients with carnitine deficiency or metabolic disorders that may result in clinically significant deficiency, because the drug causes renal excretion of carnitine.

Cefditoren is not recommended for prolonged use since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. Short-term treatment with cefditoren has not been associated with clinical effects of decreased carnitine levels.

Cefditoren should not be given to patients with milk protein hypersensitivity (not lactose intolerance), because the tablets contain sodium caseinate, a milk protein.

Prior to initiation of cefditoren, it should be determined if the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Caution is recommended if cefditoren is given to penicillin-sensitive patients. If an allergic reaction (including anaphylaxis) to cefditoren occurs, the drug should be discontinued. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support and airway management as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following cephalosporin therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Cephalosporins may be associated with a fall in prothrombin activity. Risk factors include renal or hepatic impairment, poor nutritional state, a protracted course of antimicrobial therapy, and chronic anticoagulation therapy. Prothrombin times should be monitored and vitamin K therapy initiated if indicated.

Several cephalosporins have been associated with seizures, particularly when inappropriately high doses were administered to renally impaired patients. The drug should be discontinued if seizures occur. Renal function should be monitored, especially in elderly patients.

Superinfection with nonsusceptible organisms (i.e., yeasts) may occur with prolonged cephalosporin therapy. Appropriate measures should be taken if superinfection occurs.

Caution is recommended in patients with a history of colitis or other gastrointestinal disorders.

Safety and effectiveness have not been established in pediatric patients less than 12 years of age. Cefditoren is not recommended for this population.

Dialysis

Data not available

Approximately 30% of cefditoren was removed by hemodialysis (4 hours duration) without any changes to terminal half-life.

Other Comments

Cefditoren should be taken with meals for optimal absorption.

Coadministration of cefditoren with agents that reduce stomach acids (including antacids) is not recommended.

To reduce the development of drug-resistant organisms, antibiotics should only be used for prophylaxis or treatment of infections that are proven or strongly suspected to be due to bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.