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cefdinir

 

Classes: Cephalosporins, 3rd Generation

Dosing and uses of Cefdinir

 

Adult dosage forms and strengths

capsule

  • 300mg

oral suspension

  • 125mg/5mL
  • 250mg/5mL

 

Community-Acquired Pneumonia

Disease caused by Haemophilus influenzae (including beta-lactamase-producing strains), Haemophilus parainfluenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including beta-lactamase-producing strains)

300 mg PO q12hr for 10 days

 

Respiratory Tract Infections

Acute exacerbations of chronic bronchitis caused by H influenzae (including beta-lactamase-producing strains), H parainfluenzae (including beta-lactamase-producing strains), S pneumoniae (penicillin-susceptible strains only), or M catarrhalis (including beta-lactamase-producing strains); pharyngitis and tonsillitis caused by Streptococcus pyogenes

300 mg PO q12hr for 5-10 days or 600 mg PO q24hr for 10 days

 

Acute Maxillary Sinusitis

Disease caused by H influenzae (including beta-lactamase-producing strains), S pneumoniae (penicillin-susceptible strains only), or M catarrhalis (including beta-lactamase-producing strains)

300 mg PO q12hr or 600 mg PO q24hr for 10 days

 

Skin/Skin Structure Infections

Uncomplicated infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or S pyogenes

300 mg PO q12hr for 10 days

 

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min (adults): Not to exceed 300 mg/day PO
  • CrCl <30 mL/min (children): 7 mg/kg PO q24hr; not to exceed 300 mg/day

Hepatic impairment

  • No dosage adjustment necessary

 

Pediatric dosage forms and strengths

capsule

  • 300mg

oral suspension

  • 125mg/5mL
  • 250mg/5mL

 

Acute Bacterial Otitis Media

Disease caused by H influenzae (including beta-lactamase-producing strains), S pneumoniae (penicillin-susceptible strains only), or M catarrhalis (including beta-lactamase-producing strains)

<6 months: Safety and efficacy not established

6 months-12 years: 7 mg/kg PO q12hr for 5-10 days or 14 mg/kg PO q24hr for 10 days

 

Pharyngitis/Tonsillitis

Disease caused by S pyogenes

<6 months: Safety and efficacy not established

6 months-12 years: 7 mg/kg PO q12hr for 5-10 days or 14 mg/kg PO q24hr for 10 days

>12 years or >43 kg: 300 mg PO q12hr for 5-10 days or 600 mg PO q24hr for 10 days

 

Acute Maxillary Sinusitis

Disease caused by H influenzae (including beta-lactamase-producing strains), S pneumoniae (penicillin-susceptible strains only), or M catarrhalis (including beta-lactamase-producing strains)

<6 months: Safety and efficacy not established

6 months-12 years: 7 mg/kg PO q12hr or 14 mg/kg PO q24hr for 10 days

>12 years or >43 kg: 300 mg PO q12hr or 600 mg PO q24hr for 10 days

 

Skin/Skin Structure Infections

Uncomplicated infections caused by S aureus (including beta-lactamase-producing strains) or S pyogenes

<6 months: Safety and efficacy not established

6 months-12 years: 7 mg/kg PO q12hr for 10 days

>12 years or >43 kg: 300 mg PO q12hr for10 days

 

Administration

Coadministration with iron-containing supplements

  • Iron interferes with cefdinir absorption; administer cefdinir at least 2 hours before or after iron supplements
  • Iron-fortified infant formula does not significantly interfere with cefdinir absorption, therefore, cefdinir can be administered with iron-fortified infant formula
  • Reddish stools in patients receiving cefdinir have been reported; in many cases, patients were also receiving iron-containing products; reddish color is due to formation of nonabsorbable complex between cefdinir or its breakdown products and iron in GI tract

 

Cefdinir adverse (side) effects

>10%

Diarrhea (8-15%)

 

1-10%

Vaginal moniliasis (<4%)

Nausea (3%)

Rash (3%)

Headache (2%)

Increased urine leukocytes (2%)

Increased urine protein (1-2%)

Decreased lymphocytes (1%)

Glycosuria (1%)

Increased alkaline phosphatase (1%)

Increased eosinophils (1%)

Increased platelets (1%)

 

Warnings

Contraindications

Documented hypersensitivity

 

Cautions

Note differences between twice-daily and once-daily dosing regimens

Use with caution in patients with history of penicillin allergy; if allergic reaction to cefdinir occurs, discontinue therapy

Dosage adjustments may be necessary if CrCl is <30 mL/min

Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy

Use caution in patients with history of colitis

Antacids containing magnesium or aluminum interfere with absorption of cefdinir; if this required during therapy, administer at least 2 hr before or after antacid

Iron supplements, including multivitamins that contain iron, interfere with absorption of cefdinir; if iron supplements required administer at least 2 hours before or after supplement

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Unknown whether drug is excreted in milk

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Cefdinir

Mechanism of action

Third-generation cephalosporin; inhibits mucopeptide synthesis in bacterial cell wall; typically bactericidal, depending on organism susceptibility, dose, and serum or tissue concentrations

 

Absorption

Bioavailability: 16-21% (capsule); 25% (suspension)

Peak plasma time: 2-4 hr

Plasma protein: 60-70%

 

Distribution

Distributed into blister fluid, middle-ear fluid, tonsils, sinus tissue, bronchial mucosa, epithelial lining fluid

Vd: 0.29-1.05 L/kg (6 months-12 years); 0.06-0.64 L/kg (adults)

 

Metabolism

Not appreciably metabolized

 

Elimination

Half-life: 100 min

Excretion: Urine (7-25% as unchanged drug)