Drug class: Third Generation Cephalosporins
Molecular formula: C₁₄H₁₃N₅O₅S₂
CAS number: 91832-40-5

Medically reviewed by Drugs.com on Sep 17, 2024. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.

Uses for Cefdinir

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci). Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.

AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis; other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.

If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae (penicillin-susceptible strains only), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains). Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis. Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment. If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.

Treatment of mild to moderate acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae (penicillin-susceptible strains only) or β-lactamase- and non-β-lactamase-producing H. influenzae, H. parainfluenzae, or M. catarrhalis.

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (penicillin-susceptible strains only) or β-lactamase- and non-β-lactamase-producing strains of H. influenzae, H. parainfluenzae, or M. catarrhalis. If an oral cephalosporin used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend cefdinir, cefditoren, cefpodoxime, cefprozil, or cefuroxime.

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including β-lactamase-producing strains) or S. pyogenes.

Cefdinir Dosage and Administration

Administration

Oral Administration

Administer orally.

Capsules and oral suspension may be given without regard to meals. (See Food under Pharmacokinetics.)

For most infections, may be given once daily or in 2 divided doses every 12 hours; once-daily regimen not recommended for treatment of CAP or skin and skin structure infections.

Reconstitution

Reconstitute oral suspension at time of dispensing by adding amount of water specified on the container in 2 portions; invert bottle and shake after each addition.

Reconstituted suspension contains 125 or 250 mg of cefdinir/5 mL.

Shake suspension well prior to administration of each dose.

Dosage

Pediatric Patients

General Pediatric Dosage

Oral

Children beyond neonatal period: AAP recommends 14 mg/kg daily in 1 or 2 equally divided doses for treatment of mild or moderate infections. AAP states the drug is inappropriate for treatment of severe infections.

Acute Otitis Media (AOM)

Oral

Children 6 months through 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days or 7 mg/kg every 12 hours for 5–10 days.

AAP does not recommend oral anti-infective regimens of <10 days’ duration in children <2 years of age or in patients with severe symptoms.

Pharyngitis and Tonsillitis

Oral

Children 6 months through 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days or 7 mg/kg every 12 hours for 5–10 days.

Children ≥13 year of age or weighing ≥43 kg: 600 mg once daily for 10 days or 300 mg every 12 hours for 5–10 days.

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.

Respiratory Tract Infections

Acute Sinusitis

Oral

Children 6 months through 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days or 7 mg/kg every 12 hours for 10 days.

Children ≥13 years of age or weighing ≥43 kg: 600 mg once daily for 10 days or 300 mg every 12 hours for 10 days.

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥13 year of age: 600 mg once daily for 10 days or 300 mg every 12 hours for 5–10 days.

Community-acquired Pneumonia

Oral

Children ≥13 year of age: 300 mg every 12 hours for 10 days.

Skin and Skin Structure Infections

Oral

Children 6 months through 12 years of age weighing <43 kg: 7 mg/kg every 12 hours for 10 days.

Children ≥13 year of age or weighing ≥43 kg: 300 mg every 12 hours for 10 days.

Adults

Pharyngitis and Tonsillitis

Oral

600 mg once daily for 10 days or 300 mg every 12 hours for 5–10 days.

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.

Respiratory Tract Infections

Acute Sinusitis

Oral

600 mg once daily for 10 days or 300 mg every 12 hours for 10 days.

Acute Exacerbations of Chronic Bronchitis

Oral

600 mg once daily for 10 days or 300 mg every 12 hours for 5–10 days.

Community-acquired Pneumonia

Oral

300 mg every 12 hours for 10 days.

Skin and Skin Structure Infections

Oral

300 mg every 12 hours for 10 days.

Prescribing Limits

Pediatric Patients

Oral

Maximum 600 mg daily.

Adults

Oral

Maximum 600 mg daily.

Special Populations

Hepatic Impairment

Dosage adjustments not required.

Renal Impairment

Dosage adjustments recommended in patients with severe renal impairment (Cl_cr <30 mL/minute) or undergoing hemodialysis.

Adults with Cl_cr <30 mL/minute: 300 mg once daily.

Children with Cl_cr <30 mL/minute per 1.73 m²: 7 mg/kg (maximum 300 mg) once daily.

Patients maintained on long-term hemodialysis: Recommended initial dosage is 300 mg every 48 hours in adults or 7 mg/kg (maximum 300 mg) every 48 hours in children. Administer a supplemental dose (300 mg in adults or 7 mg/kg in children) at end of each dialysis period.

Geriatric Patients

No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)

Cautions for Cefdinir

Contraindications

• Known hypersensitivity to cefdinir or other cephalosporins.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged use. Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.

If an allergic reaction occurs, discontinue cefdinir and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive to penicillins: avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefdinir and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

History of GI Disease

Use cephalosporins with caution in patients with a history of GI disease, particularly colitis. (See Superinfection/Clostridium-difficile-associated Diarrhea and Colitis under Cautions.)

Diabetes Mellitus

Depending on the manufacturer, reconstituted oral suspension contains 1.37–2.86 g of sucrose per 5 mL.

Specific Populations

Pregnancy

Category B.

Lactation

Not detected in milk.

Pediatric Use

Safety and efficacy not established in neonates and infants <6 months of age.

Use for treatment of acute maxillary sinusitis in children 6 months through 12 years of age supported by evidence from studies in adults and adolescents, similar pathophysiology of acute sinusitis in adults and children, and data regarding cefdinir pharmacokinetics in children.

Adverse effects reported in pediatric patients similar to those in adults. Increased incidence of diarrhea and rash in pediatric patients ≤2 years of age compared with older pediatric patients.

Geriatric Use

Well tolerated in geriatric patients; incidence of adverse effects (including diarrhea) lower than in younger adults.

Hepatic Impairment

Hepatic metabolism is negligible; dosage adjustments not required.

Renal Impairment

Increased plasma half-life and decreased total body clearance.

Dosage adjustments necessary in patients with severe renal impairment (Cl_cr <30 mL/minute) or undergoing hemodialysis. (See Renal Impairment under Dosage and Administration.)

Careful clinical observation and renal function tests recommended prior to and during cephalosporin therapy.

Common Adverse Effects

GI effects (diarrhea, nausea) and rash.

Drug Interactions

Specific Drugs and Laboratory Tests

Cefdinir Pharmacokinetics

Absorption

Bioavailability

16–25%. Peak plasma concentrations attained 2–4 hours after an oral dose.

Bioavailability of oral suspension is 120% of that reported with capsules.

Food

Administration of cefdinir capsules or oral suspension with a high-fat meal decreases rate and extent of absorption; not considered clinically important.

Special Populations

Peak plasma concentrations and AUC may be higher in geriatric patients than in younger adults.

Distribution

Extent

Distributed into blister fluid, middle ear fluid, tonsils, sinus tissue, and bronchial mucosa and epithelial lining fluid in concentrations ranging from 15–48% of concurrent plasma concentrations.

Not known whether distributed into CSF.

Not detected in milk following single 600-mg oral dose.

Plasma Protein Binding

60–70% in adult and pediatric patients; binding is independent of concentration.

Elimination

Metabolism

Not appreciably metabolized.

Elimination Route

Eliminated principally by renal excretion; approximately 12–18% eliminated unchanged in urine.

Half-life

1.7–1.8 hours in adults with normal renal function.

Special Populations

Pharmacokinetics not studied to date in hepatic impairment.

Clearance decreased in renal impairment. Plasma elimination half-life 2 times higher in patients with Cl_cr 30–60 mL/minute and 5 times higher in those with Cl_cr <30 mL/minute compared with normal renal function.

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).

For Suspension

20–25°C (may be exposed to 15–30°C). Following reconstitution, store suspension in tight container at controlled room temperature; discard after 10 days.

Actions and Spectrum

• Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.

• Usually bactericidal.

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.

• In vitro spectrum of activity includes many gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against anaerobic bacteria, fungi, and viruses.

• Usually less active in vitro against susceptible staphylococci than first generation cephalosporins, however more active against susceptible staphylococci and streptococci than many other oral third generation cephalosporins (e.g., cefixime, cefpodoxime, ceftibuten).

• Gram-positive aerobes: Active in vitro and in clinical infections against S. pneumoniae (penicillin-susceptible strains only), S. pyogenes (group A β-hemolytic streptococci), and Staphylococcus aureus. Also active in vitro against S. agalactiae (group B streptococci), S. epidermidis (methicillin-susceptible [oxacillin-susceptible] strains only), and viridans streptococci. Enterococci (e.g., Enterococcus faecalis) and methicillin-resistant (oxacillin-resistant) staphylococci are resistant.

• Gram-negative aerobes: Active in vitro and in clinical infections against non-β-lactamase-producing and β-lactamase-producing strains of H. influenzae, H. parainfluenzae, and M. catarrhalis. Also active in vitro against Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Inactive against most strains of Enterobacter and Pseudomonas aeruginosa.

• Stable in the presence of a wide variety of β-lactamases produced by gram-negative and gram-positive bacteria; may be hydrolyzed by certain plasmid-mediated extended-spectrum β-lactamases.

• Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefdinir, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.

Advice to Patients

• Advise patients that antibacterials (including cefdinir) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).

• Importance of completing full course of therapy, even if feeling better after a few days.

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefdinir or other antibacterials in the future.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

• Importance of taking cefdinir at least 2 hours before or after antacids containing aluminum or magnesium or iron supplements (including multivitamins containing iron).

• Importance of discontinuing cefdinir and informing clinician if an allergic reaction occurs.

• For patients with diabetes, importance of being informed of sucrose content of oral suspension.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, or concomitant illness.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• Cefdinir - Can a capsule be broken open and sprinkled on food?

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