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Pronunciation:

(SEF di ner)

U.S. Brand Names:

Omnicef®

Synonyms:

CFDN

Generic Available:

Canadian Brand Names:

Omnicef®

Use:

Treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute bacterial otitis media, acute maxillary sinusitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections.

Pregnancy Risk Factor:

Lactation:

Enters breast milk (small amounts)/use caution

Contraindications:

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

Warnings/Precautions:

Administer cautiously to penicillin-sensitive patients, especially IgE-mediated reactions (eg, anaphylaxis, urticaria). There is evidence of partial cross-allergenicity and cephalosporins cannot be assumed to be an absolutely safe alternative to penicillin in the penicillin-allergic patient. Serum sickness-like reactions have been reported. Signs and symptoms occur after a few days of therapy and resolve a few days after drug discontinuation with no serious sequelae. Pseudomembranous colitis occurs; consider its diagnosis in patients who develop diarrhea with antibiotic use.

Adverse Reactions:

1% to 10%:

Dermatologic: Cutaneous moniliasis (1%)

Gastrointestinal: Diarrhea (8%), rash (3%), vomiting (1%), increased GGT (1%)

<1% (Limited to important or life-threatening): Leukopenia, nausea, vaginal moniliasis, rash, Stevens-Johnson syndrome, exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, erythema nodosum, hepatitis, cholestasis, hepatic failure, jaundice, anaphylaxis, shock, edema, laryngeal edema, hemorrhagic colitis, enterocolitis, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, ITP, hemolytic anemia, respiratory failure, asthma exacerbation, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, coagulopathy, DIC, upper gastrointestinal bleeding, peptic ulcer, ileus, loss of consciousness, vasculitis, cardiac failure, chest pain, MI, hypertension, involuntary movements, rhabdomyolysis

Reactions reported with other cephalosporins include dizziness, fever, headache, encephalopathy, asterixis, neuromuscular excitability, seizure, aplastic anemia, interstitial nephritis, toxic nephropathy, angioedema, hemorrhage, prolonged PT, serum-sickness reactions, and superinfection

Overdosage/Toxicology:

After acute overdose, most agents cause only nausea, vomiting, and diarrhea, although neuromuscular hypersensitivity and seizures are possible, especially in patients with renal insufficiency. Hemodialysis may be helpful to aid in the removal of the drug from the blood but not usually indicated, otherwise most treatment is supportive or symptom-directed following GI decontamination.

Drug Interactions:

Decreased effect: Coadministration with iron or antacids reduces the rate and extent of cefdinir absorption

Increased effect: Probenecid increases the effects of cephalosporins by decreasing the renal elimination in those which are secreted by tubular secretion

Increased toxicity: Anticoagulant effects may be increased when administered with cephalosporins

Stability:

Oral suspension should be mixed with 38 mL water for the 60 mL bottle and 63 mL of water for the 120 mL bottle. After mixing, the suspension can be stored at room temperature (25°C/77°F). The suspension may be used for 10 days. The suspension should be shaken well before each administration.

Mechanism of Action:

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.

Pharmacodynamics/Kinetics:

Protein binding: 60% to 70%

Metabolism: Minimally hepatic

Bioavailability: Capsule: 16% to 21%; suspension 25%

Half-life elimination: 100 minutes

Excretion: Primarily urine

Dosage:

Oral:

Children: 7 mg/kg/dose twice daily for 5-10 days or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day)

Adolescents and Adults: 300 mg twice daily or 600 mg once daily for 10 days

Dosing adjustment in renal impairment: Clcr<30 mL/minute: 300 mg once daily

Hemodialysis removes cefdinir; recommended initial dose: 300 mg (or 7 mg/kg/dose) every other day. At the conclusion of each hemodialysis session, 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.

Monitoring Parameters:

Observe for signs and symptoms of anaphylaxis during first dose

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Complete full course of medication, even if you feel better. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause diarrhea (yogurt, boiled milk, or buttermilk may help); or nausea, vomiting, flatulence (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report severe, unresolved diarrhea; opportunistic infection (vaginal itching or drainage, sores in mouth, blood in stool or urine, unusual fever or chills); skin rash; or respiratory difficulty. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

Mental Health: Effects on Psychiatric Treatment:

May rarely cause neutropenia; use caution with clozapine and carbamazepine

Dosage Forms:

Capsule: 300 mg

Powder for oral suspension: 125 mg/5 mL (60 mL, 100 mL) [contains sodium benzoate; strawberry flavor]; 250 mg/5 mL (60 mL, 100 mL) [contains sodium benzoate; strawberry flavor]

International Brand Names:

Cefzon® (JP); Omnicef® (CA, EG, ID, JO, KW, LB, SY, TH); Sefdin® (IN)

References

Marshall WF and Blair JE, "The Cephalosporins,"Mayo Clin Proc, 1999, 74(2):187-95.

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