Medically reviewed by Drugs.com. Last updated on Apr 27, 2020.
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- Cefditoren Pivoxil
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Spectracef: 400 mg [contains sodium caseinate]
Generic: 200 mg [DSC], 400 mg [DSC]
Brand Names: U.S.
- Antibiotic, Cephalosporin (Third Generation)
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.
9.3 ± 1.6 L
Cefditoren pivoxil is hydrolyzed by esterases to cefditoren (active) and pivalate; cefditoren is not appreciable metabolized
Urine (as cefditoren and pivaloylcarnitine)
Time to Peak
1.5 to 3 hours
1.6 ± 0.4 hours; increased with moderate (2.7 hours) and severe (4.7 hours) renal impairment
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)
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.
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
Refer to adult dosing.
Bronchitis, chronic; acute bacterial exacerbation: Children ≥12 years and Adolescents: Oral: 400 mg twice daily for 10 days.
Infants ≥8 months and Children: Limited data available: Oral: 3 mg/kg/dose 3 times daily for 5 days; dosing based on a prospective study comparing 5 days of cefditoren (n=103, age range: 0.7 to 12.4 years) to 10 days of amoxicillin (n=155); efficacy and tolerability were similar for both groups; Note: Cefditoren was administered as a granule formulation that is not available in the US (Ozaki 2008).
Children ≥12 years and Adolescents: Oral: 200 mg twice daily for 10 days.
Pneumonia, community-acquired: Children ≥12 years and Adolescents: Oral: 400 mg twice daily for 10 to 14 days. Note: Based on experience with other antibiotics, a shorter duration (10 days) of therapy may be appropriate based on patient severity and response (IDSA [Bradley 2011]).
Rhinosinusitis, acute bacterial: Limited data available: Children and Adolescents ≤15 years: Oral: 4 to 6 mg/kg/dose twice daily for 14 day; reported maximum daily dose: 400 mg/day (Poachanukoon 2008; Poachanukoon 2015); dosing based on two prospective studies. In one trial, cefditoren (4 to 6 mg/kg/dose twice daily) (n=66) was compared to high-dose amoxicillin/clavulanate (n=72) for acute bacterial rhinosinusitis in patients aged 1 to 15 years; both treatments offered similar efficacy; however, cefditoren was associated with less diarrhea (Poachanukoon 2008). Another study compared low-dose cefditoren (4 to 6 mg/kg/dose twice daily) to high-dose cefditoren (8 to 12 mg/kg/dose twice daily); efficacy and tolerability were similar between the groups (Poachanukoon 2015). Note: Cefditoren was administered as a granule formulation that is not available in the US.
Skin and skin structure infections, uncomplicated: Children ≥12 years and Adolescents: Oral: 200 mg twice daily for 10 days.
Administer with meals.
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.
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Monitor therapy
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
Histamine H2 Receptor 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
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®).
>10%: Gastrointestinal: Diarrhea (11% to 15%)
1% to 10%:
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%), urine abnormality (increased leukocytes: 2%)
Hematologic & oncologic: Decreased hematocrit (2%)
Nervous system: Headache (2% to 3%)
<1%, postmarketing, and/or case reports: Abnormal dreams, acute renal failure, decreased serum albumin, anorexia, arthralgia, asthma, change in WBC count (decrease or increase), coagulation time increased, constipation, decreased hemoglobin, decreased neutrophils, decreased serum calcium, decreased serum sodium, diaphoresis, dizziness, drowsiness, dysgeusia, eosinophilic pneumonitis, eosinophilia, eructation, erythema multiforme, facial edema, fever, flatulence, fungal infection, gastritis, gastrointestinal disease, hyperglycemia, hypersensitivity reaction, hypochloremia, hypoglycemia (Kennedy 2019), hypophosphatemia, increased appetite, increased blood urea nitrogen, increased serum ALT, increased serum AST, increased serum cholesterol, increased serum potassium, increased thirst, insomnia, interstitial pneumonitis, leukopenia, leukorrhea, lymphocytosis, myalgia, nervousness, oral candidiasis, oral mucosa ulcer, pain, peripheral edema, pharyngitis, positive direct Coombs test, pseudomembranous colitis, proteinuria, pruritus, rhinitis, sinusitis, skin rash, Stevens-Johnson syndrome, stomatitis, thrombocythemia, thrombocytopenia, toxic epidermal necrolysis, urinary frequency, urticaria, vaginitis, weakness, weight loss, xerostomia
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.
• 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.
• Duration of therapy: Not for long-term therapy due to the possible development of carnitine deficiency over time.
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Pregnancy Risk Factor
An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.
What is this drug used for?
• It is used to treat bacterial infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Sore throat
• Severe loss of strength and energy
• Unable to pass urine
• Change in amount of urine passed
• Vaginal pain, itching, and discharge
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about cefditoren
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Imprints, Shape & Color Data
- Drug Interactions
- En Español
- 3 Reviews
- Drug class: third generation cephalosporins
Other brands: Spectracef