cefditoren


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cefditoren

(seff-di-tore-en) ,

Spectracef

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: third generation cephalosporins
Pregnancy Category: B

Indications

Treatment of the following infections caused by susceptible organisms:, :
  • Acute exacerbations of chronic bronchitis,
  • Community-acquired pneumonia,
  • Pharyngitis and tonsillitis,
  • Uncomplicated skin and skin structure infections.

Action

Binds to bacterial cell wall membrane, causing cell death.

Therapeutic effects

Bactericidal action against susceptible bacteria.
Active against the following gram-positive organisms:, :
  • Staphylococcus aureus(methicillin-susceptible strains, including β-lactamase-producing strains),
  • Streptococcus pneumoniae(penicillin-susceptible strains only),
  • Streptococcus pyogenes.
Active against the following gram-negative organisms:
  • Haemophilus influenzae (including β-lactamase-producing strains),
  • Haemophilus parainfluenzae(including β-lactamase-producing strains),
  • Moraxella catarrhalis (including β-lactamase-producing strains).

Pharmacokinetics

Absorption: Cefditoren pivoxil is a prodrug that is converted to cefditoren (the active component) in GI tract during absorption. Bioavailability 14% in fasting state, increased by high fat meal.
Distribution: Widely distributed.
Protein Binding: 88%.
Metabolism and Excretion: Mostly excreted unchanged by the kidneys.
Half-life: 1.6 hr (increased in renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
rapidrapid1.5–3 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to cephalosporins; Serious hypersensitivity to penicillins; Carnitine deficiency or inborn errors of metabolism resulting in significant carnitine deficiency (produces renal excretion of carnitine); Milk protein hypersensitivity (contains sodium caseinate).
Use Cautiously in: Renal impairment (dosage adjustment recommended if CCr <50 mL/min); Geriatric: Dose adjustment due to age-related decrease in renal function may be necessary; Obstetric / Lactation / Pediatric: Pregnancy, lactation or children <12 yr(safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • seizures (high doses) (life-threatening)
  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting

Genitourinary

  • hematuria
  • vaginal moniliasis

Hematologic

  • bleeding
  • eosinophilia
  • hemolytic anemia
  • lymphocytosis
  • neutropenia
  • thrombocytosis

Miscellaneous

  • allergic reactions including anaphylaxis
  • superinfection

Interactions

Drug-Drug interaction

Antacids and histamine H2 receptor antagonists decrease absorption (avoid concurrent use).Probenecid decreases excretion and increases blood levels.

Route/Dosage

Oral (Adults and Children ≥12 yr) Acute bacterial exacerbation of chronic bronchitis, community–acquired pneumonia—400 mg twice daily; Pharyngitis/tonsillitis, uncomplicated skin/skin structure infections—200 mg twice daily.

Renal Impairment

Oral (Adults and Children ≥12 yr) CCr 30–49 mL/min—dose should not exceed 200 mg twice daily; CCr <30 mL/min—dose should not exceed 200 mg once daily.

Availability

Tablets: 200 mg, 400 mg

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning and throughout therapy.
  • Before initiating therapy, obtain a history to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
  • Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
  • Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue the drug and notify the physician or other health care professional immediately if these occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Lab Test Considerations: May cause positive results for Coombs’ test.
    • Monitor prothrombin time and assess patient for bleeding (guaiac stools; check for hematuria, bleeding gums, ecchymosis) daily in high-risk patients; may cause hypoprothrombinemia.
    • May cause ↑ serum AST, ALT, and BUN.
    • May rarely cause neutropenia, eosinophilia, lymphocytosis, and thrombocytosis.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Diarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • 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.
  • Oral: Administer with meals to enhance absorption.
    • Do not administer concomitantly with antacids or other drugs taken to reduce stomach acid.

Patient/Family Teaching

  • Instruct patient to take medication around the clock at evenly spaced times and to finish the medication completely, even if feeling better. Take missed doses as soon as possible unless it is almost time for next dose; do not double doses. Advise patient that sharing of this medication may be dangerous.
  • Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
  • Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
  • Inform female patients that cefditoren can be taken concomitantly with oral contraceptives.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
References in periodicals archive ?
Antimicrobial susceptibility of Streptococcus pyogenes in Central, Eastern, and Baltic European Countries, 2005 to 2006: the cefditoren surveillance program.
Antimicrobial susceptibility of Streptococcus pyogenes in Central Eastern, and Baltic European Countries, 2005 to 2006: the cefditoren surveillance program.
He was treated as sinusitis with cefditoren pivoxil 2x200 mg daily for 15 days before admission.
06 [micro]g; ml of penicillin G can also be considered susceptible to these parenteral agents, as well as to parenteral ertapenem, imipenem and meropenem and to oral ampicillin, amoxicillin, amoxicillin/clavulanate, cefader, cefdinir, cefditoren, cefprozil, cefuroxime and cefpodoxime.
He was treated with lincomycin and cefditoren pivoxil with no improvement.
An oral cephalosporin recently approved for the treatment of respiratory pathogens, cefditoren (Spectracef) is highly protein bound, leaving its potency comparable with that of previous cephalosporins.
Other new drugs, notably the ketolides and cefditoren, a new cephalosporin, will soon be available, Dr.
Cefditoren in vitro activity and spectrum: a review of international studies using reference methods.
Vansen's current product portfolio of anti-infectives, including Factive[R], Spectracef[R] and Cefditoren Pivoxil[R], provides a strong and stable revenue base from which to grow and expand our company.
Along with our recently acquired products Spectracef[R] and its authorized generic Cefditoren Pivoxil, our sales force now has a powerful anti-infective franchise portfolio of products.