Medically reviewed by Drugs.com. Last updated on Jul 17, 2020.
(SEF di ner)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 300 mg
Suspension Reconstituted, Oral:
Generic: 125 mg/5 mL (60 mL, 100 mL); 250 mg/5 mL (60 mL, 100 mL)
- Antibiotic, Cephalosporin (Third Generation)
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.
Penetrates into blister fluid, middle ear fluid, tonsils, sinus, and lung tissues. Vd: Children 6 months to 12 years: 0.67 ± 0.38 L/kg; Adults: 0.35 ± 0.29 L/kg
Primarily urine (~12% to 18% as unchanged drug)
Time to Peak
2 to 4 hours
1.7 (± 0.6) hours with normal renal function
60% to 70%
Special Populations: Renal Function Impairment
Clearance is reduced.
Special Populations Note
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:
Infants ≥6 months of age and children ≤12 years of age: Cmax (peak):
7 mg/kg oral suspension, single dose: 2.3 ± 0.65 mg/L.
14 mg/kg oral suspension, single dose: 3.86 ± 0.62 mg/L.
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).
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: Limitations of use: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (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
Off Label Uses
Urinary tract infection, complicated, including pyelonephritis
Clinical experience suggests the utility of cefdinir as an alternative agent in the treatment of acute complicated UTI (including pyelonephritis) after administration of an appropriate parenteral agent [Hooton 2018a].
Urinary tract infection, acute uncomplicated cystitis or acute simple cystitis
Clinical experience suggests the utility of cefdinir as an alternative agent in the treatment of acute simple cystitis (infection limited to the bladder and no signs/symptoms of upper tract or systemic infections) [Hooton 2018b], [Hooton 2018c].
Based on the Infectious Diseases Society of America and European Society for Microbiology and Infectious Diseases (IDSA/ESCMID) international clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women, cefdinir is an effective and recommended alternative agent in the management of acute uncomplicated cystitis [ESCMID/IDSA [Gupta 2011]].
Hypersensitivity to cefdinir, any component of the formulation, or other cephalosporins.
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) (Sethi 2020).
Oral: 300 mg twice daily or 600 mg once daily for 3 to 7 days (GOLD 2020; Sethi 2020; manufacturer's labeling).
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) (Limb 2019; manufacturer's labeling).
Streptococcal pharyngitis (group A) (alternative agent for mild [non-anaphylactic] penicillin allergy): Oral: 300 mg twice daily for 5 to 10 days or 600 mg once daily for 10 days (Pichichero 2020; manufacturer's labeling).
Urinary tract infection (alternative agent) (off-label use): Note: Use only when preferred agents cannot be used (due to limited evidence and decreased efficacy of oral beta-lactams compared to other agents) (IDSA/ESCMID [Gupta 2011]; Hooton 2018a; Hooton 2018b; Hooton 2018c).
Acute uncomplicated cystitis or acute simple cystitis (infection limited to bladder and no signs/symptoms of upper tract, prostate, or systemic infection): Oral: 300 mg twice daily for 5 to 7 days (IDSA/ESCMID [Gupta 2011]; Hooton 2018b; Hooton 2018c).
Urinary tract infection, complicated, including pyelonephritis: Oral: 300 mg twice daily for 10 to 14 days. Note: Oral therapy should follow appropriate parenteral therapy and patients should be monitored closely. For outpatient treatment of mild infection, a single dose of a long-acting parenteral agent is acceptable before transitioning to oral therapy (IDSA/ESCMID [Gupta 2011]; Hooton 2018a).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
General dosing, susceptible infection (Red Book 2012): Mild to moderate infections: Infants, Children, and Adolescents: Oral: 14 mg/kg/day in divided doses 1 to 2 times daily; maximum daily dose: 600 mg/day
Bronchitis, acute exacerbation: Oral: Adolescents: 300 mg every 12 hours for 5 to 10 days or 600 mg every 24 hours for 10 days
Otitis media, acute: Infants ≥6 months and Children: Oral: 14 mg/kg/day in divided doses every 12 to 24 hours for 5 to 10 days; maximum daily dose: 600 mg/day. Variable duration of therapy: If <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-day course (AAP [Lieberthal 2013]). Note: Recommended by the AAP as an alternative agent for initial treatment in penicillin allergic patients (AAP [Lieberthal 2013]).
Pharyngitis/Tonsillitis: Note: Although FDA approved at twice daily dosing, duration <10 days is not recommended (Shulman 2012).
Infants ≥6 months and Children: Oral: 7 mg/kg/dose every 12 hours for 5 to 10 days or 14 mg/kg/dose every 24 hours for 10 days; maximum daily dose: 600 mg/day
Adolescents: Oral: 300 mg every 12 hours for 5 to 10 days or 600 mg every 24 hours for 10 days
Pneumonia, community-acquired: Adolescents: Oral: 300 mg every 12 hours for 10 days
Skin and skin structure infection, uncomplicated:
Infants ≥6 months and Children: Oral: 14 mg/kg/day in divided doses twice daily for 10 days; maximum daily dose: 600 mg/day
Adolescents: Oral: 300 mg every 12 hours for 10 days
Sinusitis, acute maxillary: Note: Due to decreased S. pneumonia sensitivity, cefdinir is no longer recommended as monotherapy for the initial empiric treatment of sinusitis (Chow 2012)
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
Adolescents: Oral: 300 mg every 12 hours or 600 mg every 24 hours for 10 days
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to manufacturer’s product labeling for reconstitution instructions.
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.
Store at 20°C to 25°C (68°F to 77°F). Store reconstituted suspension at room temperature 20°C to 25°C (68°F to 77°F) for 10 days.
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). 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. Avoid combination
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. Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. 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 Consider therapy modification
Probenecid: May increase the serum concentration of Cephalosporins. 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. 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. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
False-positive reaction for urinary ketones may occur with nitroprusside- but not nitroferricyanide-based tests. False-positive urine glucose results may occur when using Clinitest®, Benedict's solution, or Fehling’s solution; glucose-oxidase-based reaction systems (eg, Clinistix®, Tes-Tape®) are recommended. May cause positive direct Coombs’ test.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Diarrhea (8% to 15%)
1% to 10%:
Central nervous system: Headache (2%)
Dermatologic: Skin rash (≤3%)
Endocrine & metabolic: Decreased serum bicarbonate (≤1%), glycosuria (≤1%), hyperglycemia (≤1%), hyperphosphatemia (≤1%), increased gamma-glutamyl transferase (≤1%), increased lactate dehydrogenase (≤1%)
Gastrointestinal: Nausea (≤3%), abdominal pain (≤1%), vomiting (≤1%)
Genitourinary: Vulvovaginal candidiasis (≤4%), urine abnormality (increased leukocytes: ≤2%), proteinuria (1% to 2%), occult blood in urine (≤1%), vaginitis (≤1%)
Hematologic & oncologic: Lymphocytosis (≤2%), eosinophilia (1%), lymphocytopenia (1%), abnormal neutrophils (functional disorder of polymorphonuclear neutrophils: ≤1%), thrombocythemia (≤1%), change in WBC count (≤1%)
Hepatic: Increased serum alkaline phosphatase (≤1%), increased serum ALT (≤1%)
Renal: Increased urine pH (≤1%), increased urine specific gravity (≤1%)
<1%, postmarketing, and/or case reports: Abnormal stools, anaphylaxis, anorexia, asthma, blood coagulation disorder, bloody diarrhea, candidiasis, cardiac failure, chest pain, cholestasis, conjunctivitis, constipation, cutaneous candidiasis, decreased hemoglobin, decreased urine specific gravity, disseminated intravascular coagulation, dizziness, drowsiness, dyspepsia, enterocolitis (acute), eosinophilic pneumonitis, erythema multiforme, erythema nodosum, exfoliative dermatitis, facial edema, fever, flatulence, fulminant hepatitis, granulocytopenia, hemolytic anemia, hemorrhagic colitis, hemorrhagic diathesis, hepatic failure, hepatitis (acute), hyperkalemia, hyperkinesia, hypersensitivity angiitis, hypertension, hypocalcemia, hypophosphatemia, immune thrombocytopenia, increased amylase, increased blood urea nitrogen, increased monocytes, increased serum AST, increased serum bilirubin, insomnia, interstitial pneumonitis (idiopathic), intestinal obstruction, involuntary body movements, jaundice, laryngeal edema, leukopenia, leukorrhea, loss of consciousness, maculopapular rash, melena, myocardial infarction, pancytopenia, peptic ulcer, pneumonia (drug-induced), pruritus, pseudomembranous colitis, renal disease, renal failure (acute), respiratory failure (acute), rhabdomyolysis, serum sickness, shock, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, toxic epidermal necrolysis, upper gastrointestinal hemorrhage, weakness, xerostomia
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• 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.
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Pregnancy Risk Factor B Pregnancy Considerations
An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.
What is this drug used for?
• It is used to treat bacterial infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Not able to pass urine
• Change in amount of urine passed
• Dark urine
• Yellow skin or eyes
• Sore throat
• Severe loss of strength and energy
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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- Drug class: third generation cephalosporins
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