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Cefdinir

Pronunciation

Pronunciation

(SEF di ner)

Index Terms

  • CFDN
  • Omnicef

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 300 mg

Suspension Reconstituted, Oral:

Generic: 125 mg/5 mL (60 mL, 100 mL); 250 mg/5 mL (60 mL, 100 mL)

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

Penetrates into blister fluid, middle ear fluid, tonsils, sinus, and lung tissues. Vd: Children 6 months to 12 years: 0.67 ± 0.38 L/kg; Adults: 0.35 ± 0.29 L/kg

Metabolism

Minimal

Excretion

Primarily urine (~12% to 18% as unchanged drug)

Time to Peak

2 to 4 hours

Half-Life Elimination

1.7 (± 0.6) hours with normal renal function

Protein Binding

60% to 70%

Special Populations: Renal Function Impairment

Clearance is reduced.

Use: Labeled Indications

Acute bacterial otitis media: Treatment of acute bacterial otitis media in pediatric patients caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only) and Moraxella catarrhalis (including beta-lactamase-producing strains).

Acute exacerbations of chronic bronchitis: Treatment of acute exacerbations of chronic bronchitis in adults and adolescents caused by H. influenzae (including beta-lactamase producing strains), H. parainfluenzae (including beta-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only) and M. catarrhalis (including beta-lactamase-producing strains).

Acute maxillary sinusitis: Treatment of acute maxillary sinusitis in adults and adolescents caused by H. influenzae (including beta-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only) and M. catarrhalis (including beta-lactamase-producing strains). Note: Limitations of use: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow, 2012).

Community-acquired pneumonia: Treatment of community-acquired pneumonia in adults and adolescents caused by H. influenzae (including beta-lactamase-producing strains), H. parainfluenzae (including beta-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only) and M. catarrhalis (including beta-lactamase-producing strains).

Pharyngitis/Tonsillitis: Treatment of pharyngitis/tonsillitis in adults, adolescents, and pediatric patients caused by S. pyogenes.

Uncomplicated skin and skin structure infections: Treatment of uncomplicated skin and skin structure infections in adults, adolescents, and pediatric patients caused by Staphylococcus aureus (including beta-lactamase-producing strains) and S. pyogenes.

Contraindications

Hypersensitivity to cefdinir, any component of the formulation, or other cephalosporins.

Dosing: Adult

Acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis: Oral: 300 mg twice daily for 5 to 10 days or 600 mg once daily for 10 days

Acute maxillary sinusitis: Oral: 300 mg twice daily or 600 mg once daily for 10 days. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow, 2012).

Community-acquired pneumonia, uncomplicated skin and skin structure infections: Oral: 300 mg twice daily for 10 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Infants ≥6 months and Children:

Acute bacterial otitis media, pharyngitis/tonsillitis: Oral: 7 mg/kg/dose twice daily for 5 to 10 days or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day)

Acute maxillary sinusitis: Oral: 7 mg/kg/dose twice daily or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day). Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow, 2012).

Uncomplicated skin and skin structure infections: Oral: 7 mg/kg/dose twice daily for 10 days (maximum: 600 mg/day)

Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute:

Adolescents and Adults: 300 mg once daily

Infants ≥6 months and Children: 7 mg/kg once daily (maximum: 300 mg/day)

ESRD requiring intermittent hemodialysis (IHD): Dialyzable: (63%): Initial dose: 300 mg (or 7 mg/kg/dose) every other day. Postdialysis, 300 mg (or 7 mg/kg/dose) should be given. Subsequent doses (300 mg or 7 mg/kg/dose) should be administered every other day.

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Reconstitution

Refer to manufacturer’s product labeling for reconstitution instructions.

Administration

Twice daily doses should be given every 12 hours. May be administered with or without food. Manufacturer recommends administering at least 2 hours before or after antacids or iron supplements. Shake suspension well before use.

Storage

Store at 20°C to 25°C (68°F to 77°F). Store reconstituted suspension at room temperature 20°C to 25°C (68°F to 77°F) for 10 days.

Drug Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Iron Salts: May decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Cefdinir. Specifically, Iron Salts may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron-containing multivitamins when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Consider therapy modification

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

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

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

Test Interactions

False-positive reaction for urinary ketones may occur with nitroprusside- but not nitroferricyanide-based tests. False-positive urine glucose results may occur when using Clinitest®, Benedict's solution, or Fehling’s solution; glucose-oxidase-based reaction systems (eg, Clinistix®, Tes-Tape®) are recommended. May cause positive direct Coombs’ test.

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (8% to 15%)

1% to 10%:

Central nervous system: Headache (2%)

Dermatologic: Skin rash (≤3%)

Endocrine & metabolic: Decreased serum bicarbonate (≤1%), glycosuria (≤1%), hyperglycemia (≤1%), hyperphosphatemia (≤1%), increased gamma-glutamyl transferase (≤1%), increased lactate dehydrogenase (≤1%)

Gastrointestinal: Nausea (≤3%), abdominal pain (≤1%), vomiting (≤1%)

Genitourinary: Vulvovaginal candidiasis (≤4%), proteinuria (1% to 2%), occult blood in urine (≤1%), urine alkalinization (≤1%), vaginitis (≤1%)

Hematologic & oncologic: Elevated urine leukocytes (≤2%), lymphocytosis (≤2%), eosinophilia (1%), lymphocytopenia (1%), functional disorder of polymorphonuclear neutrophils (≤1%), thrombocythemia (≤1%), change in WBC count (≤1%)

Hepatic: Increased serum alkaline phosphatase (≤1%), increased serum ALT (≤1%)

Renal: Increased urine specific gravity (≤1%)

<1% (Limited to important or life-threatening): Abnormal stools, anaphylaxis, anorexia, asthma, blood coagulation disorder, bloody diarrhea, candidiasis, cardiac failure, chest pain, cholestasis, conjunctivitis, constipation, cutaneous candidiasis, decreased hemoglobin, decreased urine specific gravity, disseminated intravascular coagulation, dizziness, drowsiness, dyspepsia, enterocolitis (acute), eosinophilic pneumonitis, erythema multiforme, erythema nodosum, exfoliative dermatitis, facial edema, fever, flatulence, fulminant hepatitis, granulocytopenia, hemolytic anemia, hemorrhagic colitis, hemorrhagic diathesis, hepatic failure, hepatitis (acute), hyperkalemia, hyperkinesia, hypersensitivity angiitis, hypertension, hypocalcemia, hypophosphatemia, immune thrombocytopenia, increased amylase, increased blood urea nitrogen, increased monocytes, increased serum AST, increased serum bilirubin, insomnia, interstitial pneumonitis (idiopathic), intestinal obstruction, involuntary body movements, jaundice, laryngeal edema, leukopenia, leukorrhea, loss of consciousness, maculopapular rash, melena, myocardial infarction, pancytopenia, peptic ulcer, pneumonia (drug-induced), pruritus, pseudomembranous colitis, renal disease, renal failure (acute), respiratory failure (acute), rhabdomyolysis, serum sickness, shock, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, toxic epidermal necrolysis, upper gastrointestinal hemorrhage, weakness, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• 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:

• Colitis: Use with caution in patients with a history of colitis.

• Renal impairment: Use with caution in patients with renal impairment (CrCl <30 mL/minute); dosage adjustment may be required.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Iron-containing products: Cases of reddish stools have been reported with concomitant use of cefdinir and iron-containing products due to the formation of a nonabsorbable complex in the GI tract.

Monitoring Parameters

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

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic 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 diarrhea. Have patient report immediately to prescriber bruising, bleeding, urinary retention, change in amount of urine passed, chills, pharyngitis, severe loss of strength and energy, seizures, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose 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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