cefditoren pivoxil
Spectracef

Available forms
Available by prescription only
Tablets: 200 mg

Indications and dosages
 Acute bacterial exacerbation of chronic bronchitis caused by Haemophilus influenza, H. parainfluenzae, Streptococcus pneumoniae, Moraxella catarrhalis. Adults and adolescents age 12 and older: 400 mg P.O. b.i.d. with meals for 10 days.
 Pharyngitis or tonsillitis caused by S. pyogenes. Adults and adolescents age 12 and older: 200 mg P.O. b.i.d. with meals for 10 days.
 Uncomplicated skin and skin structure infections caused by S. pyogenes. Adults and adolescents age 12 and older: 200 mg P.O. b.i.d. with meals for 10 days.
≡ Dosage adjustment. For patients with moderate renal impairment (creatinine clearance 30 to 49 ml/minute), don’t give more than 200 mg b.i.d. For patients with severe renal impairment (creatinine clearance less than 30 ml/minute), give 200 mg daily.

Pharmacodynamics
Antibacterial action: Primarily bactericidal. Drug acts by adhering to bacterial penicillin-binding proteins, thereby inhibiting cell wall synthesis. Cefditoren is active against many gram-positive and gram-negative organisms, including Staphylococcus aureus (methicillin-susceptible strains, including beta-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only), S. pyogenes,H. influenzae (including beta-lactamase-producing strains), H. parainfluenzae (including beta-lactamase-producing strains), and M. catarrhalis (including beta-lactamase-producing strains).

Pharmacokinetics
Absorption: Absorbed from the GI tract. Giving drug with a meal increases its absolute bioavailability.
Distribution: Distributed widely into most body tissues and fluids based on volume of distribution. CSF penetration is unknown. Drug is about 88% protein-bound.
Metabolism: Not appreciably metabolized.
Excretion: Excreted mainly in urine by glomerular filtration and tubular secretion. Elimination half-life is 1.2 to 2 hours in patients with normal renal function.

Contraindications and precautions
Contraindicated in patients hypersensitive to drug or other cephalosporins. Also contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. Because cefditoren tablets contain sodium caseinate, a milk protein, don’t give to patients hypersensitive to milk protein (as distinct from those with lactose intolerance).
  Use cautiously in breast-feeding women and patients with impaired renal function or penicillin allergy.

Interactions
Drug-drug. H₂-receptor antagonists, magnesium and aluminum antacids: Reduces cefditoren absorption. Avoid use together.
Probenecid: Increases cefditoren levels. Avoid use together.
Drug-food. Moderate or high-fat meal: Increases cefditoren bioavailability. Advise patient to take drug with meals.

Adverse reactions
CNS: headache.
GI: abdominal pain, dyspepsia, diarrhea, nausea, vomiting.
GU: vaginal candidiasis, hematuria, increased WBC count in urine.
Metabolic: hyperglycemia.

Effects on lab test results
• May increase serum glucose levels.
• May decrease hematocrit.

Overdose and treatment
Signs and symptoms of overdose may include nausea, vomiting, epigastric distress, diarrhea, and seizures.
 Treatment is symptomatic and supportive. Cefditoren may be removed by hemodialysis, if needed.

Special considerations
• Use of drug may cause a false-positive direct Coombs’ test result and false-positive reaction for glucose in urine, using copper reduction tests (those involving Benedict’s solution, Fehling’s solution, or Clinitest tablets). Its use also decreases prothrombin activity in patients with renal or hepatic impairment, patients in a poor nutritional state, patients receiving a protracted course of antibiotics, and patients previously stabilized on anticoagulants.
• Give drug with a fatty meal to increase its bioavailability.
• If patient develops diarrhea after receiving cefditoren, keep in mind that this drug may cause pseudomembranous colitis.
• Don’t use this drug if patient needs prolonged treatment.
• Monitor patient for overgrowth of resistant organisms.
Breast-feeding patients
• Cephalosporins appear in breast milk; use cautiously in breast-feeding women. Safety hasn’t been established.
Pediatric patients
• Safety and efficacy in patients younger than age 12 haven’t been established.
Geriatric patients
• Dosage adjustment may be needed for elderly patients with abnormal renal function.

Patient education
• Instruct patient to take drug exactly as prescribed.
• Tell patient to take drug with food to increase its absorption.
• Caution patient not to take drug with an H₂ antagonist or an antacid because they may reduce cefditoren absorption.
• Inform patient of potential adverse reactions.
• Instruct patient not to stop taking drug before completing treatment and to immediately call if unpleasant adverse reactions develop.
• Encourage patient to report if signs and symptoms of infection don’t improve after several days of therapy.
• Urge patient not to miss any doses. However, if he does, tell him to take the missed dose as soon as possible unless it’s within 4 hours of the next scheduled dose. In that case, tell him to skip the missed dose and go back to the regular dosing schedule. Tell him not to double the dose.
• Advise patient to report if she is pregnant or breast-feeding.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use