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Cefdinir: Drug information

Cefdinir: Drug information
(For additional information see "Cefdinir: Patient drug information" and see "Cefdinir: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Omnicef
Pharmacologic Category
  • Antibiotic, Cephalosporin (Third Generation)
Dosing: Adult
Chronic obstructive pulmonary disease, acute exacerbation

Chronic obstructive pulmonary disease, acute exacerbation: Note: Avoid use in patients with risk factors for Pseudomonas infection or poor outcomes (eg, ≥65 years of age with major comorbidities, FEV1 <50% predicted, frequent exacerbations) (Ref).

Oral: 300 mg twice daily or 600 mg once daily for 5 to 7 days (Ref).

Odontogenic soft tissue infection, pyogenic

Odontogenic soft tissue infection, pyogenic (initial therapy for mild infection or step-down therapy after parenteral treatment) (alternative agent) (off-label use):

Note: For patients unable to take penicillin (Ref).

Oral: 300 mg twice daily in combination with metronidazole; continue until clinical resolution, typically for 7 to 14 days. Use in addition to appropriate surgical management (eg, drainage and/or extraction) (Ref).

Otitis media, acute

Otitis media, acute (alternative agent for mild [nonanaphylactic] penicillin allergy ): Limited data available: Oral: 300 mg twice daily or 600 mg once daily; duration of therapy is 5 to 7 days (mild to moderate infection) or 10 days (severe infection) (Ref).

Rhinosinusitis, acute bacterial

Rhinosinusitis, acute bacterial (alternative agent for patients with penicillin allergy who are able to tolerate cephalosporins):

Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (Ref).

Oral: 300 mg twice daily with clindamycin for 5 to 7 days (Ref); some experts use as monotherapy when the risk of drug-resistant S. pneumoniae is low (eg, <65 years of age, low endemic resistance, few comorbidities, no recent hospitalization or antibiotic use) (Ref).

Streptococcal pharyngitis, group A

Streptococcal pharyngitis, group A (alternative agent for mild, nonanaphylactic penicillin allergy):

Note: Cephalosporin selection depends on the type of hypersensitivity reaction to penicillin. To avoid the development of resistance, narrower spectrum cephalosporins (eg, cephalexin or cefadroxil) are preferred when possible (Ref).

Oral: 300 mg twice daily for 5 to 10 days or 600 mg once daily for 10 days (Ref).

Urinary tract infection

Urinary tract infection (alternative agent) (off-label use): Note: Use only when first-line agents cannot be used; limited evidence suggests inferior efficacy of oral beta-lactams (Ref).

Cystitis, acute uncomplicated or acute simple cystitis (infection limited to bladder without signs/symptoms of upper tract, prostate, or systemic infection): Oral: 300 mg twice daily for 5 to 7 days (Ref).

Urinary tract infection, complicated (including pyelonephritis): Oral: 300 mg twice daily for 10 to 14 days. Note: Oral beta-lactam therapy should generally follow appropriate parenteral therapy (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function (Ref): Oral:

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

CrCl <30 mL/minute: 300 mg once daily.

Hemodialysis, intermittent (thrice weekly): Dialyzable (~63%) (Ref):

Note: Limited pharmacokinetic data have demonstrated prolonged half-lives and increased serum concentrations in patients undergoing intermittent hemodialysis (Ref).

Oral: Administer a 300 mg initial dose, followed by 300 mg 3 times per week postdialysis on dialysis days, with an additional 300 mg dose 48 hours into each 72-hour interdialytic period (eg, if dosed Monday/Wednesday/Friday on dialysis days, administer an additional 300 mg dose on Sunday) (Ref).

Alternatively, pharmacokinetic parameters suggest that 300 mg initially, followed by 300 mg 3 times per week after hemodialysis sessions should be sufficient to meet pharmacokinetic/pharmacodynamic goals (Ref).

Peritoneal dialysis: Slightly dialyzable (Ref):

Note: Limited pharmacokinetic data have demonstrated prolonged half-lives and increased serum concentrations in patients undergoing peritoneal dialysis (Ref).

Oral: 300 mg every 48 hours (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse reactions due to drug accumulation is important.

Oral: 300 mg every 12 hours (Ref). Note: In general, use of IV antimicrobial therapy or alternative oral therapies with greater bioavailability may be preferred in patients receiving CRRT (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse reactions due to drug accumulation is important.

Oral: 300 mg every 12 hours on PIRRT days; 300 mg every 24 hours on non-PIRRT days (expert opinion). Note: In general, use of IV antimicrobial therapy or alternative oral therapies with greater bioavailability may be preferred in patients receiving PIRRT (Ref).

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Pediatric

(For additional information see "Cefdinir: Pediatric drug information")

General dosing: Infants, Children, and Adolescents: Oral: 14 mg/kg/day in divided doses every 12 to 24 hours; maximum daily dose: 600 mg/day (Ref).

Note: Every-24-hour dosing may be suboptimal, particularly for Streptococcus pneumoniae that are nonsusceptible to penicillin and bacteria with minimum inhibitory concentrations (MICs) ≥0.5 mg/L, based on pharmacokinetic modeling (Ref).

Bronchitis, chronic; acute bacterial exacerbation

Bronchitis, chronic; acute bacterial exacerbation: Adolescents: Oral: 300 mg every 12 hours for 5 to 10 days or 600 mg every 24 hours for 10 days.

Otitis media, acute

Otitis media, acute (AOM) (alternative agent for nonanaphylactic penicillin allergy):

Infants ≥6 months and Children: Oral: 14 mg/kg/day in divided doses every 12 to 24 hours; maximum daily dose: 600 mg/day (Ref). For patients with severe or recurrent AOM, tympanic membrane perforation, or who are <2 years of age, treat for 10 days; for patients ≥2 years of age with mild to moderate, nonrecurrent disease without tympanic membrane perforation, shorter durations of 5 to 7 days may be sufficient (Ref). Note: Twice-daily dosing is preferred, especially if shorter durations (ie, 5 days) are used (Ref).

Pneumonia, community-acquired

Pneumonia, community-acquired (alternative agent): Note: Cefdinir is not active against most strains of penicillin-resistant streptococci and is not approved for treatment of pneumonia caused by penicillin-nonsusceptible S. pneumoniae. Neither pediatric nor adult guidelines recommend cefdinir for patients with pneumonia due to known or suspected S. pneumoniae (Ref).

Adolescents: Oral: 300 mg every 12 hours for 10 days (Ref). Note: Durations as short as 5 days, depending on patient response, are recommended in adult community-acquired pneumonia guidelines for patients who are improving clinically (Ref).

Rhinosinusitis, acute bacterial

Rhinosinusitis, acute bacterial (alternative agent for patients with penicillin allergy):

Note: The role of cefdinir in the management of acute bacterial sinusitis is limited; other options are preferred (Ref).

Infants ≥6 months and Children: Oral: 14 mg/kg/day in divided doses every 12 to 24 hours for 10 days; maximum daily dose: 600 mg/day (Ref).

Adolescents: Oral: 300 mg every 12 hours or 600 mg every 24 hours for 10 days (Ref).

Skin and soft tissue infection, uncomplicated

Skin and soft tissue infection, uncomplicated (alternative agent): Note: Cefdinir is not currently recommended in IDSA guidelines for treatment of skin and soft tissue infection; alternate agents are preferred (eg, first-generation cephalosporins). Additionally, durations shorter than 10 days (eg, 5 days) may be appropriate for uncomplicated infections (Ref).

Infants ≥6 months and Children: Oral: 7 mg/kg/dose every 12 hours for 10 days; maximum dose: 300 mg/dose.

Adolescents: Oral: 300 mg every 12 hours for 10 days.

Streptococcus, group A; pharyngitis/tonsillitis

Streptococcus, group A; pharyngitis/tonsillitis (alternative agent for nonanaphylactic penicillin allergy): Note: Narrow-spectrum cephalosporins (eg, cephalexin) are preferred over broad-spectrum cephalosporins such as cefdinir (Ref).

Infants ≥6 months and Children: Oral: 14 mg/kg/day in divided doses every 12 to 24 hours; maximum daily dose: 600 mg/day (Ref). Preferred treatment duration is 10 days (Ref), though 5 days may be adequate if cefdinir is dosed twice daily (Ref).

Adolescents: Oral: 300 mg every 12 hours or 600 mg every 24 hours (Ref). Preferred treatment duration is 10 days (Ref), though 5 days may be adequate if cefdinir is dosed twice daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants ≥6 months and Children:

CrCl ≥30 mL/minute/1.73 m2: No adjustment required.

CrCl <30 mL/minute/1.73 m2: 7 mg/kg/dose every 24 hours; maximum dose: 300 mg/dose.

Adolescents:

CrCl ≥30 mL/minute: No adjustment required.

CrCl <30 mL/minute: 300 mg every 24 hours.

Hemodialysis: Dialyzable (63%): Infants ≥6 months, Children, and Adolescents: Initial dose: 7 mg/kg/dose (maximum dose: 300 mg) every other day. At the conclusion of each hemodialysis session, an additional dose (7 mg/kg/dose up to 300 mg) should be given. Subsequent doses should be administered every other day.

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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

Capsule, Oral:

Omnicef: 300 mg

Suspension Reconstituted, Oral:

Omnicef: 125 mg/5 mL (60 mL, 100 mL)

Administration: Adult

Oral: 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.

Administration: Pediatric

Oral: May administer with or without food; administer with food if stomach upset occurs; administer cefdinir at least 2 hours before or after antacids or iron supplements; shake suspension well before use.

Use: Labeled Indications

Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute exacerbations of chronic bronchitis in adults and adolescents caused by Haemophilus influenzae (including beta-lactamase-producing strains), Haemophilus parainfluenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including beta-lactamase-producing strains)

Otitis media, acute: Treatment of acute bacterial otitis media in pediatric patients caused by H. influenzae (including beta-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only), and M. catarrhalis (including beta-lactamase-producing strains)

Pneumonia, community-acquired: 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)

Sinusitis, acute: 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: According to the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis, cefdinir is recommended in combination with clindamycin due to concern for pneumococcal resistance (IDSA [Chow 2012]).

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

Streptococcal pharyngitis, group A: Treatment of pharyngitis/tonsillitis in adults, adolescents, and pediatric patients caused by S. pyogenes

Use: Off-Label: Adult

Odontogenic soft tissue infection, pyogenic; Urinary tract infection, complicated, including pyelonephritis; Urinary tract infection, acute uncomplicated cystitis or acute simple cystitis

Adverse Reactions (Significant): Considerations
Antibiotic-associated (non–Clostridioides difficile) diarrhea

GI effects range from antibiotic-associated [non–Clostridioides difficile] diarrhea (AAD), nausea, and vomiting. Most cases of AAD are mild and self-limiting. However, Clostridioides difficile may account for as many as >20% of cases in children, adolescents, and adults (discussed separately) (Ref).

Mechanism: Dose- and time-related; antibiotic disruption of indigenous gut microbiota (Ref).

Onset: Varied; mean time to onset of AAD is 3 to 18 days for adult patients and 2 to 6 days for pediatric patients. The majority of AAD cases occur during (versus after) antibiotic therapy in pediatric patients (Ref).

Risk factors:

• Duration of therapy (Ref)

• Age (pediatric patients <2 years of age and older adults) (Ref)

• Length of hospitalization or ICU stay (Ref)

• Duration of proton pump inhibitor use (Ref)

• Parenteral nutrition (Ref)

• Combinations of antibiotics (Ref)

Clostridioides difficile diarrhea

Clostridioides difficile infection (CDI) has occurred with cefdinir, including Clostridioides difficile associated diarrhea (CDAD) and Clostridioides difficile colitis (Ref).

Mechanism: Dose- and time-related; related to cumulative antibiotic exposure. Cefdinir may cause disruption of the intestinal microbiota resulting in the overgrowth of pathogens, such as C. difficile (Ref)

Onset: Varied; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).

Risk factors:

• Antibiotic exposure (highest risk factor) (Ref)

• Type of antibiotic (third-/fourth-generation cephalosporins among the highest risk) (Ref)

• Long durations in a hospitalization or other health care setting (recent or current) (Ref)

• Older adults (Ref)

• Immunocompromised conditions (Ref)

• A serious underlying condition (Ref)

• GI surgery/manipulation (Ref)

• Antiulcer medications (eg, proton pump inhibitors, H2 blockers) (Ref)

• Chemotherapy (Ref)

Hypersensitivity reactions (immediate and delayed)

Hypersensitivity reactions (immediate and delayed) range from skin rash to rare cases of anaphylaxis. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Mechanism: Non–dose-related; immunologic. Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria) are IgE-mediated. Delayed hypersensitivity reactions, including maculopapular rash and SCARs, are T-cell-mediated (Ref).

Onset: Immediate hypersensitivity reactions: Rapid; occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Maculopapular reactions: Intermediate; occur 7 to 10 days after initiation. Other reactions (including SCARs): Varied; occur days to 8 weeks after initiation (Ref).

Risk factors:

• Cross-reactivity between penicillins and cephalosporins and among cephalosporins is mostly related to side chain similarity (Ref). A meta-analysis showed negligible cross-reactivity between penicillins and third-generation cephalosporins, such as cefdinir (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

1% to 10%:

Dermatologic: Skin rash (≤3%)

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

Gastrointestinal: Abdominal pain (≤1%), nausea (≤3%), vomiting (≤1%)

Genitourinary: Increase in urinary protein (1% to 2%), microscopic hematuria (1%), vaginitis (≤1%), vulvovaginal candidiasis (≤4%)

Hematologic & oncologic: Eosinophilia (≤1%), leukocyte disorder (increase or decrease in polymorphonuclear leukocytes [PMN]: ≤1%), leukocyturia (≤2%), lymphocytopenia (≤1%), lymphocytosis (≤2%), thrombocythemia (≤1%)

Hepatic: Increased serum alkaline phosphatase (≤1%)

Nervous system: Headache (2%)

<1%:

Dermatologic: Cutaneous candidiasis, maculopapular rash, pruritus

Endocrine & metabolic: Decreased serum calcium, decreased serum phosphate, glycosuria, increased serum glucose, increased serum phosphate, increased serum potassium

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, xerostomia

Genitourinary: Leukorrhea

Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin, decreased white blood cell count, leukocytosis, leukopenia, monocytosis

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum bilirubin

Nervous system: Dizziness, drowsiness, insomnia

Neuromuscular & skeletal: Asthenia, hyperkinetic muscle activity

Renal: Decreased urine specific gravity, increased blood urea nitrogen, increased urine pH, increased urine specific gravity

Postmarketing:

Cardiovascular: Acute myocardial infarction, cardiac failure, chest pain, hypersensitivity angiitis, hypertension, shock

Dermatologic: Erythema multiforme, erythema nodosum, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Increased amylase

Gastrointestinal: Acute enterocolitis, bloody diarrhea, cholestasis, Clostridioides difficile associated diarrhea (Lv 2019), Clostridioides difficile colitis, hemorrhagic colitis, intestinal obstruction, melena, peptic ulcer, stomatitis

Hematologic & oncologic: Disseminated intravascular coagulation, granulocytopenia, hemolytic anemia, immune thrombocytopenia, pancytopenia, thrombocytopenia, upper gastrointestinal hemorrhage

Hepatic: Fulminant hepatitis, hepatic failure, hepatitis (acute), jaundice

Hypersensitivity: Anaphylaxis, facial edema

Immunologic: Serum sickness-like syndrome

Nervous system: Involuntary body movements, loss of consciousness

Neuromuscular & skeletal: Rhabdomyolysis

Ophthalmic: Conjunctivitis

Renal: Acute kidney injury (Kimura 2001)

Respiratory: Acute respiratory failure, eosinophilic pneumonitis, idiopathic interstitial pneumonitis, laryngeal edema, pneumonia (drug-induced), respiratory distress (feeling of suffocation), status asthmaticus

Miscellaneous: Fever

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

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:

• 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.

Warnings: Additional Pediatric Considerations

Iron-containing infant formulas do not affect the pharmacokinetics of cefdinir but may result in the development of red-appearing, nonbloody stools; this occurs when cefdinir is coadministered with iron-containing products and an insoluble iron-cefdinir complex forms; patients/parents should be counseled.

Metabolism/Transport Effects

Substrate of OAT1/3

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy

Antacids: May decrease the absorption of Cefdinir. Management: Administer cefdinir 2 hours before or 2 hours after aluminum- or magnesium-containing antacids. Risk D: Consider therapy modification

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

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

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

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy

Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy

Iron Preparations: 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. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop when combined. Risk D: Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

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. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop Risk D: Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: 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. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

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

Pregnancy Considerations

An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.

Breastfeeding Considerations

Cefdinir was not detectable in breast milk following a single cefdinir 600 mg dose.

In general, if antibiotics are present in breast milk, nondose-related modification of bowel flora may occur. Monitor infants for GI disturbances, such as thrush and diarrhea (WHO 2002).

Monitoring Parameters

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

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.

Pharmacokinetics

Distribution: Penetrates into blister fluid, middle ear fluid, tonsils, sinus, and lung tissues.

Vd:

Infants ≥6 months and Children ≤2 years: 0.67 ± 0.38 L/kg.

Adults: 0.35 ± 0.29 L/kg.

Protein binding: 60% to 70%.

Metabolism: Minimal.

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

Half-life elimination:

Infants ≥6 months and Children ≤10 years: Mean range: 1.26 to 1.81 hours (Bowlware 2006).

Adults: 1.7 ± 0.6 hours with normal renal function.

Time to peak, plasma: 2 to 4 hours.

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

Pharmacokinetics: Additional Considerations

Altered kidney function: Clearance is reduced.

Anti-infective considerations:

Parameters associated with efficacy:

Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC):

Enterobacterales: Goal: 30% to 40% fT > MIC (bacteriostatic), 60% to70% fT > MIC (bactericidal) (Craig 1998; Turnidge 1998).

Streptococcus spp. and H. influenzae: Goal: >40% fT > MIC (Craig 1998; Turnidge 1998).

Expected drug concentration in normal renal function:

Pediatric patients: Cmax (peak):

7 mg/kg oral suspension, single dose: Infants ≥6 months and Children: 2.3 ± 0.65 mg/L.

14 mg/kg oral suspension, single dose:

Infants ≥6 months and Children: 3.86 ± 0.62 mg/L.

Nonfasting: Infants ≥6 months and Children ≤10 years: 2.07 ± 1.08 mg/L (Bowlware 2006).

Fasting: Infants ≥6 months and Children ≤10 years: 1.8 ± 1.2 mg/L (Bowlware 2006).

25 mg/kg oral suspension, single dose:

Nonfasting: Infants ≥6 months and Children ≤10 years: 3.7 ± 1.45 mg/L (Bowlware 2006).

Fasting: Infants ≥6 months and Children ≤10 years: 4.42 ± 2.58 mg/L (Bowlware 2006).

Adults: Cmax (peak):

300 mg oral capsule, single dose: 1.6 ± 0.55 mg/L.

600 mg oral capsule, single dose: 2.87 ± 1.01 mg/L.

Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998).

Pricing: US

Capsules (Cefdinir Oral)

300 mg (per each): $5.11

Suspension (reconstituted) (Cefdinir Oral)

125 mg/5 mL (per mL): $0.85

250 mg/5 mL (per mL): $1.65 - $1.66

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Adcef (IN);
  • Addcef (VN);
  • Adinir (BD);
  • Anicef (KR);
  • Anycef (KR);
  • Cedenir (EG);
  • Cednir (BD);
  • Cefdiar (KR);
  • Cefnaxl (PH);
  • Cefnir (BD, PK);
  • Cefralin (PE);
  • Cefzon (CN, JP);
  • Celofarm (CL);
  • Danircap (VN);
  • Haginir DT (VN);
  • Kefnir (MY, VN);
  • Maxdinir (EG);
  • Medsidin (VN);
  • Nilocef (BD);
  • Nircef (ID);
  • Nirocef (PH);
  • Omicef (PH);
  • Omnicef (AE, BB, BH, BM, BS, BZ, CY, EG, GY, ID, IL, IQ, IR, JM, JO, KR, KW, LB, LY, NL, OM, PR, QA, SA, SE, SR, SY, TH, TT, VN, YE);
  • Omnicef R (CR, DO, GT, HN, NI, PA, SV);
  • Orcef-DS (PH);
  • Samnir (TH);
  • Sefarin (LB);
  • Sefdin (IN);
  • Sefdy (PH);
  • Torbener (EG);
  • Trinir (PH)


For country code abbreviations (show table)
  1. American Academy of Pediatrics (AAP). In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021.
  2. Anzueto A, Sethi S, Martinez FJ. Exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2007;4(7):554-564. [PubMed 17878469]
  3. Based on expert opinion.
  4. Block SL, Busman TA, Paris MM, Bukofzer S. Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media. Pediatr Infect Dis J. 2004;23(9):834-838. doi:10.1097/01.inf.0000137574.28711.c4 [PubMed 15361722]
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