Cefditoren Pivoxil

Trade Names:Spectracef- Tablets 200 mg

Pharmacology

Inhibits mucopeptide synthesis in bacterial cell wall.

Pharmacokinetics

Absorption

C _max is about 1.8 mcg/mL. T _max is 1 to 3 h. Cefditoren dipivoxil is about 14% bioavailable.

Administration following a high-fat meal increased AUC 70% and C _max 50%.

Distribution

Vd is about 9.3 L (at steady state). About 88% protein bound, primarily to albumin.

Metabolism

Hydrolyzed to cefditoren by esterases.

Elimination

The t _½ is about 1.6 h. Eliminated by excretion into the urine. Renal Cl is about 4 to 5 L/h.

Special Populations

Unbound C _max is 90% higher, AUC is 232% higher, and t _½ is 2.7 h.

Unbound C _max is 114% higher, AUC is 324% higher, and t _½ is 4.7 h. Dosage adjustment is recommended.

C _max is increased 26% and AUC 33%, t _½ is 16% to 26% longer, and renal Cl is 20% to 24% lower. No dosage adjustment is needed.

Indications and Usage

Treatment of mild to moderate infections of acute bacterial exacerbation of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin-structure infections caused by susceptible strains of specific microorganisms.

Contraindications

Hypersensitivity to cephalosporins or milk protein; carnitine deficiency or inborn errors of metabolism that result in clinically important carnitine deficiency.

Dosage and Administration

PO 400 mg twice daily for 10 days.

PO 200 mg twice daily for 10 days.

PO No dosage adjustment is necessary.

PO less than 200 mg twice daily.

PO 200 mg daily.

PO Dose not determined.

General Advice

Administer each dose with food to increase absorption.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Protect from light and moisture.

Drug Interactions

May decrease cefditoren plasma levels, possibly reducing the efficacy.

May increase plasma levels and the duration of activity of cefditoren.

Laboratory Test Interactions

May cause false-positive direct Coombs test; may cause false-positive urine glucose test results with Benedict or Fehling solution or Clinitest tablets but not with enzyme-based tests (eg, Clinistix , Tes-Tape ); may cause false-negative test in the ferricyanide test for blood glucose but not the glucose oxidase or hexokinase methods of determination.

Adverse Reactions

CNS

Headache; reversible hyperactivity; seizures.

Dermatologic

Stevens-Johnson syndrome; erythema multiforme; toxic epidermal necrolysis.

GI

Diarrhea; nausea; abdominal pain; dyspepsia; vomiting; pseudomembranous colitis; colitis.

Genitourinary

Vaginal moniliasis; hematuria; increased urine WBC; renal dysfunction; toxic nephropathy.

Hematologic

Decreased hematocrit; aplastic anemia; hemolytic anemia; hemorrhage; pancytopenia; neutropenia; agranulocytosis.

Hepatic

Hepatic dysfunction (eg, cholestasis).

Metabolic

Increased glucose.

Miscellaneous

Allergic reactions; anaphylaxis; drug fever; hypertonia; superinfection; serum sickness-like reaction.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not determined in children under 12 yr of age.

Elderly

Because elderly patients are more likely to have decreased renal function, select dose with caution.

Hypersensitivity

Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.

Renal Function

Dosage adjustment is necessary.

Superinfection

Drug may cause bacterial or fungal overgrowth of nonsusceptible microorganisms.

Pseudomembranous colitis

Consider pseudomembranous colitis as a possibility in patients who develop diarrhea.

Overdosage

Symptoms

Nausea, vomiting, epigastric distress, diarrhea, convulsions.

Patient Information

• Review dosing schedule and prescribed length of therapy with patient.
• Instruct patient to take each dose with food to enhance absorption.
• Instruct patient not to take antacids or other acid-suppressive therapy (eg, H ₂ -receptor antagonists, proton pump inhibitors) concomitantly with this medication.
• Remind patient, family, or caregiver to complete entire course of therapy, even if symptoms of infection have disappeared.
• Advise patient, family, or caregiver to discontinue therapy and contact the health care provider immediately if skin rash, hives, itching, or shortness of breath occurs.
• Advise patient, family, or caregiver to report the following signs of superinfection to health care provider: black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
• Warn patient, family, or caregiver that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.

Copyright © 2009 Wolters Kluwer Health.