Dosing and uses of Spectracef (cefditoren)
Adult dosage forms and 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)
Pediatric dosage forms and strengths
<12 years old: Safety & efficacy not established
>12 years old: As in adults
Spectracef (cefditoren) adverse (side) effects
>10%
Diarrhea (11-15%)
1-10%
Nausea (4-6%)
Headache (2-3%)
Abdominal pain (2%)
Dyspepsia (1-2%)
Vomiting (1%)
<1%
Bacterial/fungal superinfection
C. difficile colitis
Hypersensitivity
Increased bleeding time
Stevens-Johnson syndrome
Vaginal moniliasis
Warnings
Contraindications
Documented hypersensitivity to drug, penicillin, related compounds, or milk protein sodium caseinate; carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency
Cautions
May cause diarrhea, nausea, and vaginal moniliasis (yeast infection); pseudomembranous colitis may occur; clinical manifestations of carnitine deficiency may occur with prolonged use; prolonged use may result in emergence and overgrowth of resistant organisms; caution in breastfeeding
Pregnancy and lactation
Pregnancy category: B
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Spectracef (cefditoren)
Half-Life: 1.2-2 hr
Peak Plasma Time: 1.5-3 hr
Excretion: urine
Mechanism of action
Semi-synthetic cephalosporin administered as prodrug. Hydrolyzed by esterases during absorption and distributed in circulating blood as active cefditoren. Bactericidal activity results from inhibition of cell wall synthesis via affinity for penicillin-binding proteins. No dose adjustment necessary for mild renal impairment (CrCl 50-80 mgL/min/1.73 m2) or mild to moderate hepatic impairment.
