Pronunciation: SEFF-dih-ner
Class: Antibiotic, Cephalosporin

Trade Names

Omnicef
- Capsules 300 mg
- Powder for oral suspension 125 mg per 5 mL after reconstitution

Pharmacology

Inhibits mucopeptide synthesis in bacterial cell wall.

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Pharmacokinetics

Absorption

T _max is 2 to 4 h. Bioavailability is 21% (capsules) and 25% (suspension). For the capsules, the C _max is about 1.6 to 2.87 mcg/mL and the AUC is about 7.05 to 11.1 mcg•h/mL.

Distribution

Vd is about 0.35 L/kg. 60% to 70% protein bound.

Metabolism

Not appreciably metabolized.

Elimination

The t _½ is about 1.7 h. Renally eliminated with 11.6% to 18.4% excreted unchanged in the urine. Renal Cl is about 2 mL/min/kg. Oral Cl is about 11.6 to 15.5 mL/min/kg. Cefdinir is dialyzable.

Special Populations

Renal Function Impairment

Cl is reduced. Dosage adjustment is recommended in patients with Ccr less than 30 mL/min.

Elderly

C _max is increased 44% and AUC by 86%. No dosage adjustment is required.

Indications and Usage

Treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis and tonsillitis, uncomplicated skin and skin structure infections, and otitis media (pediatric patients only) caused by susceptible strains of specific microorganisms.

Contraindications

Hypersensitivity to cephalosporins.

Dosage and Administration

Community-Acquired Pneumonia
Adults and Children 13 yr of age and older

PO 300 mg every 12 h for 10 days.

Acute Exacerbation of Chronic Bronchitis
Adults and Children 13 yr of age and older

PO 300 every 12 h for 5 to 10 days or 600 mg every 24 h for 10 days.

Acute Maxillary Sinusitis
Adults and Children 13 yr of age and older

PO 300 mg every 12 h or 600 mg every 24 h for 10 days.

Children 6 mo to 12 yr of age

PO 7 mg/kg every 12 h or 14 mg/kg every 24 h for 10 days.

Pharyngitis/Tonsillitis
Adults and Children 13 yr of age and older

PO 300 mg every 12 h for 5 to 10 days or 600 mg every 24 h for 10 days.

Children 6 mo to 12 yr of age

PO 7 mg/kg every 12 h for 5 to 10 days or 14 mg/kg every 24 h for 10 days.

Uncomplicated Skin and Skin Structure Infections
Adults and Children 13 yr of age and older

PO 300 mg every 12 h for 10 days.

Children 6 mo to 12 yr of age

PO 7 mg/kg every 12 h for 10 days.

Acute Bacterial Otitis Media
Children 6 mo to 12 yr of age

PO 7 mg/kg every 12 h for 5 to 10 days or 14 mg/kg every 24 h for 10 days.

Renal Impairment (Ccr less than 30 mL/min)
Adults and Children older than 13 yr of age

PO 300 mg/day.

Children 6 mo to 12 yr of age

PO 7 mg/kg/day (max, 300 mg/day).

General Advice

• Administer prescribed dose without regard to meals. Administer with food if GI upset occurs.
• Administer 2 h before or after antacids containing magnesium or aluminum, or iron supplements, including multivitamins with iron. Iron-fortified infant formula does not interfere with absorption of cefdinir, so cefdinir oral suspension can be administered with iron-fortified infant formula.
• Shake oral suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.

Storage/Stability

Store capsules, dry powder for oral suspension, and reconstituted suspension at controlled room temperature (59° to 86°F). Discard any unused suspension after 10 days.

Drug Interactions

Aluminum- or magnesium-containing antacids

Coadministration reduced absorption of cefdinir (separate doses by 2 h).

Iron supplements and vitamins with iron

Coadministration reduces absorption of cefdinir (separate doses by 2 h).

Probenecid

Inhibition of renal excretion of cefdinir.

Laboratory Test Interactions

May cause false-positive urine ketone test results when using nitroprusside reagent, but not with nitroferricyanide-based tests; may cause false positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest but not with enzyme-based tests (eg, Clinistix , Tes-Tape ); false-positive direct Coombs test result in certain patients (eg, those with azotemia); false elevations in urinary 17-ketosteroid values.

Adverse Reactions

Cardiovascular

Cardiac failure, hypertension, MI (postmarketing).

CNS

Headache (2%); involuntary movements, loss of consciousness (postmarketing).

Dermatologic

Rash (3%); erythema multiforme, erythema nodosum, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Conjunctivitis (postmarketing).

GI

Diarrhea (15%); nausea (3%); abdominal pain, vomiting (1%); acute enterocolitis, bloody diarrhea, hemorrhagic colitis, ileus, melena, peptic ulcer, pseudomembranous colitis, stomatitis, upper GI bleed (postmarketing).

Genitourinary

Vaginal moniliasis (4%); vaginitis (1%); acute renal failure, nephropathy (postmarketing).

Hematologic

Granulocytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura, leukopenia, pancytopenia, thrombocytopenia, (postmarketing).

Hepatic

Acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase (postmarketing).

Hematologic-Lymphatic

Bleeding tendency, coagulation disorder, disseminated intravascular coagulation (postmarketing).

Hypersensitivity

Allergic vasculitis, anaphylaxis, facial and laryngeal edema (postmarketing).

Lab Tests

Increased urine leukocytes and urine protein (2%); increased gamma-glutamyltransferase, decreased lymphocytes, microhematuria (1%).

Musculoskeletal

Rhabdomyolysis (postmarketing).

Respiratory

Asthma attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, respiratory failure (postmarketing).

Miscellaneous

Chest pain, feeling of suffocation, fever, shock (postmarketing).

Precautions

Monitor Response to therapy Monitor patient's response to therapy. Notify health care provider if infection does not appear to improve or worsens. Sensitivity Review results of culture and sensitivity testing as appropriate. Ensure cefdinir is discontinued and another antimicrobial agent is started if sensitivity tests indicate that the organism is resistant to cefdinir. Side effects Monitor patient for GI, DERM, and general body side effects, and signs of superinfection. Inform health care provider if noted and significant. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.

Pregnancy

Category B .

Lactation

Not detected in breast milk.

Children

Safety and efficacy in children younger than 6 mo of age not established.

Hypersensitivity

Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible crossreactivity.

Renal Function

Use drug with caution in patients with renal impairment. Dosage adjustment is recommended in patients with Ccr less than 30 mL/min.

Superinfection

May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Pseudomembranous colitis

Consider possibility in patients in whom diarrhea develops.

Hemodialysis patients

A single dose of 300 mg or 7 mg/kg (max, 300 mg) may be administered at the end of each dialysis session. Subsequent doses are then administered every other day.

Overdosage

Symptoms

Seizures, nausea, vomiting, epigastric distress, diarrhea.

Patient Information

• Review dosing schedule (ie, every 12 h or 24 h) and prescribed length of therapy with patient or caregiver. Advise patient or caregiver that dose, dosing frequency, and duration of therapy are dependent on the site and cause of infection and response to therapy.
• Reinforce to patient or caregiver the need to take exactly as prescribed and to complete the entire course of therapy, even if symptoms of infection have disappeared. Caution patient or caregiver that skipping doses or not completing the full course of therapy may allow the infection to worsen, increase the possibility that the bacteria will become resistant to the antibiotic, and/or may cause infections that will not be treatable in the future.
• Instruct patient to take each dose without regard to meals but to take with food if stomach upset occurs.
• Instruct patient to take cefdinir 2 h before or after antacids containing magnesium or aluminum, or iron-containing supplements, including multivitamins with iron. Advise caregiver that iron-containing infant formula is not a problem and cefdinir oral suspension can be administered with the formula.
• Instruct patient or caregiver administering suspension to: shake well before each use; use dosing syringe, dosing spoon, or dosing cup to measure and administer prescribed dose; and to discard any unused suspension after 10 days.
• Instruct patient to notify health care provider if infection does not appear to be improving or is worsening.
• Advise patient or caregiver to notify health care provider if severe diarrhea or diarrhea lasting 2 or 3 days occurs.
• Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not treat at home.
• Advise patient or caregiver to report signs of superinfection to health care provider: black furry tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
• Advise patient, family, or caregiver to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, or shortness of breath occurs.
• Inform patient or caregiver that stool may turn a reddish color but that this is normal and of no concern.

Copyright © 2009 Wolters Kluwer Health.