Cefditoren

Dosage Forms & Strengths

tablet

• 200mg
• 400mg

Chronic Bronchitis

Acute Bacterial Exacerbation of Chronic Bronchitis

400 mg PO q-12hr for 10 days

Pneumonia

Community-acquired

400 mg PO q12hr for 14 days

Other Infections

Pharyngitis, Tonsilitis, Uncomplicated Skin and Skin Structure Infections

200 mg PO q12hr for 10 days

Renal Impairment

CrCl 30-49 mL/minute/1.73 sq.meter: No more than 200 mg PO q12hr

CrCl <30 mL/minute/1.73/sq.meter: 200 mg PO qDay

End-stage: Dosing not established

Other Information

Take with meal to enhance absorption

Other Indications & Uses

(H. influenzae, H. parainfluenzae, S. pneumoniae, M. catarrhalis); pharyngitis/tonsillitis (S. pyogenes); skin infections (S. aureus, S. pyogenes)

<12 years old: Safety & efficacy not established

>12 years old: As in adults

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Cefditoren may be found in some form under the following brand names:

• Spectracef

Common side effects of cefditoren include the following:

• nausea
• diarrhea
• headache
• stomach pain
• upset stomach
• vomiting

This is not a complete list of cefditoren side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cefditoren. See the “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking cefditoren, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to cefditoren or to any of its ingredients
• are allergic to similar antibiotics (penicillins, cephalosporins)
• have kidney or liver problems
• have an allergy to milk protein (this product contains sodium caseinate)
• have a carnitine deficiency
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cefditoren has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from cefditoren, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Store at room temperature between 15°-30°C (59°-86°F).
• Protect from light and moisture.
• Keep this and all medications out of the reach of children.

• Cefditoren Pivoxil

• Spectracef

Cmax is increased 26% and AUC 33%, half-life is 16% to 26% longer, and renal clearance is 20% to 24% lower.

Concerns related to adverse effects:

• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Carnitine deficiency: Do not use in patients with carnitine deficiency; causes renal excretion of carnitine.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in moderate-to-severe impairment.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.

Dosage form specific issues:

• Sodium caseinate: Tablets contain sodium caseinate, which may cause hypersensitivity reactions in patients with milk protein hypersensitivity; this does not affect patients with lactose intolerance.

Other warnings/precautions:

• Duration of therapy: Not for long-term therapy due to the possible development of carnitine deficiency over time.

Adverse events have not been observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.

Uncomplicated: 200 mg orally twice a day for 10 days

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

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

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.

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.