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Cefditoren

Pronunciation

(sef de TOR en)

Index Terms

  • Cefditoren Pivoxil

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Spectracef: 200 mg [DSC], 400 mg [contains sodium caseinate]

Generic: 200 mg, 400 mg

Brand Names: U.S.

  • Spectracef

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Distribution

9.3 ± 1.6 L

Metabolism

Cefditoren pivoxil is hydrolyzed by esterases to cefditoren (active) and pivalate; cefditoren is not appreciable metabolized

Excretion

Urine (as cefditoren and pivaloylcarnitine)

Time to Peak

1.5 to 3 hours

Half-Life Elimination

1.6 ± 0.4 hours; increased with moderate (2.7 hours) and severe (4.7 hours) renal impairment

Protein Binding

88% (in vitro), primarily to albumin

Special Populations: Renal Function Impairment

Moderate impairment (CrCl 30 to 49 mL/minute/1.73 m2): Unbound Cmax is 90% higher, AUC is 232% higher

Severe impairment (CrCl less than 30 mL/minute/1.73 m2): Unbound Cmax is 114% higher, AUC is 324% higher

Special Populations: Elderly

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

Use: Labeled Indications

Treatment of acute bacterial exacerbation of chronic bronchitis or community-acquired pneumonia (due to susceptible organisms including Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae-penicillin susceptible only, Moraxella catarrhalis); pharyngitis or tonsillitis (Streptococcus pyogenes); and uncomplicated skin and skin-structure infections (Staphylococcus aureus - not MRSA, Streptococcus pyogenes)

Contraindications

Hypersensitivity to cefditoren, any component of the formulation, other cephalosporins, or milk protein; carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

Dosing: Adult

Acute bacterial exacerbation of chronic bronchitis: Oral: 400 mg twice daily for 10 days

Community-acquired pneumonia: Oral: 400 mg twice daily for 14 days

Pharyngitis, tonsillitis, uncomplicated skin and skin structure infections: Oral: 200 mg twice daily for 10 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

CrCl >50 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute/1.73 m2: Maximum dose: 200 mg twice daily

CrCl <30 mL/minute/1.73 m2: Maximum dose: 200 mg once daily

End-stage renal disease (ESRD): There are no specific dosage adjustments provided in the manufacturer’s labeling; safety and efficacy have not been established.

Dosing: Hepatic Impairment

Mild-to-moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Administer with meals.

Dietary Considerations

Cefditoren should be taken with meals. Plasma carnitine levels are decreased during therapy (39% with 200 mg dosing, 63% with 400 mg dosing); normal concentrations return within 7-10 days after treatment is discontinued.

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.

Drug Interactions

Antacids: May decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy. If antacid therapy can not be avoided, separate dosing by several hours. Consider therapy modification

H2-Antagonists: May decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with H2-antagonists and antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of H2-antagonists can not be avoided. Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Proton Pump Inhibitors: May decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

May induce a positive direct Coomb’s test. May cause a false-negative ferricyanide test. Glucose oxidase or hexokinase methods recommended for blood/plasma glucose determinations. False-positive urine glucose test when using copper reduction based assays (eg, Clinitest®).

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (11% to 15%)

1% to 10%:

Central nervous system: Headache (2% to 3%)

Endocrine & metabolic: Increased serum glucose (1% to 2%)

Gastrointestinal: Nausea (4% to 6%), abdominal pain (2%), dyspepsia (1% to 2%), vomiting (1%)

Genitourinary: Vulvovaginal candidiasis (3% to 6%), hematuria (3%)

Hematologic & oncologic: Decreased hematocrit (2%), elevated urine leukocytes (2%)

<1% (Limited to important or life-threatening): Acute renal failure, decreased serum albumin, arthralgia, asthma, change in WBC count (decrease or increase), coagulation time increased, decreased serum calcium, decreased serum sodium, eosinophilic pneumonitis, erythema multiforme, fungal infection, hyperglycemia, hypersensitivity reaction, increased blood urea nitrogen, increased serum potassium, interstitial pneumonitis, leukopenia, leukorrhea, positive direct Coombs test, pseudomembranous colitis, skin rash, Stevens-Johnson syndrome, thrombocythemia, thrombocytopenia, toxic epidermal necrolysis

Warnings/Precautions

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.

Monitoring Parameters

Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

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.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea or diarrhea. Have patient report immediately to prescriber bruising, bleeding, chills, pharyngitis, severe loss of strength and energy, urinary retention, passing out, seizures, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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