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Product Name
CEFDINER-ELSaad (dry powder)
Chemical Name
Therapeutic Category
Pharmacologic Category
Antibiotic, Cephalosporin (Third Generation)
Pharmaceutical Form
Dry powder
Cefdinir 125mg/5ml
Monitoring Parameters
Dosing: Adult
Acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis:
Oral: 300 mg twice daily for 5-10 days or 600 mg once daily for 10 days
Acute maxillary sinusitis: Oral: 300 mg twice daily or 600 mg once daily for 10 days
Community-acquired pneumonia, uncomplicated skin and skin structure infections: Oral: 300 mg twice daily for 10 days
Dosing: Pediatric
Children 6 months to 12 years:
Acute bacterial otitis media, pharyngitis/tonsillitis: Oral: 7 mg/kg/dose twice daily for 5-10 days or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day)
Acute maxillary sinusitis: Oral: 7 mg/kg/dose twice daily or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day)
Uncomplicated skin and skin structure infections: Oral: 7 mg/kg/dose twice daily for 10 days (maximum: 600 mg/day)
Children >12 years: Refer to adult dosing.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment
Clcr <30 mL/minute:
Children: 7 mg/kg once daily (maximum: 300 mg/day)
Adults: 300 mg once daily
Dosing: Hepatic Impairment
No adjustment necessary.
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.
Adverse Reactions
>10%: Gastrointestinal: Diarrhea (8% to 15%)
1% to 10%:
Central nervous system: Headache (2%)
Dermatologic: Rash (≤3%)
Endocrine & metabolic: Bicarbonate decreased (≤1%), hyperglycemia (≤1%), hyperphosphatemia (≤1%)
Gastrointestinal: Nausea (≤3%), abdominal pain (≤1%), vomiting (≤1%)
Genitourinary: Vaginal moniliasis (≤4%), urine leukocytes increased (≤2%), urine pH increased (≤1%), urine specific gravity increased (≤1%), vaginitis (≤1%)
Hematologic: Lymphocytes increased (≤2%), eosinophils increased (1%), lymphocytes decreased (1%), platelets increased (≤1%), PMN changes (≤1%), WBC decreased/increased (≤1%)
Hepatic: Alkaline phosphatase increased (≤1%), ALT increased (≤1%)
Renal: Proteinuria (1% to 2%), microhematuria (≤1%), glycosuria (≤1%)
Miscellaneous: GGT increased (≤1%), lactate dehydrogenase increased (≤1%)
<1%, postmarketing, and/or case reports: Allergic vasculitis, amylase increased, anaphylaxis, anorexia, asthma, AST increased, bilirubin increased, bleeding tendency, bloody diarrhea, BUN increased, cardiac failure, chest pain, cholestasis, coagulation disorder, conjunctivitis, constipation, cutaneous moniliasis, disseminated intravascular coagulation (DIC), dizziness, dyspepsia, enterocolitis (acute), eosinophilic pneumonia, erythema multiforme, erythema nodosum, exfoliative dermatitis, facial edema, fever, flatulence, fulminant hepatitis, granulocytopenia, hemoglobin decreased, hemolytic anemia, hemorrhagic colitis, hepatic failure, hepatitis (acute), hyperkalemia, hyperkinesia, hypertension, hypocalcemia, hypophosphatemia, idiopathic thrombocytopenia purpura, ileus, insomnia, interstitial pneumonia (idiopathic), involuntary movement, jaundice, laryngeal edema, leukopenia, leukorrhea, loss of consciousness, maculopapular rash, melena, moniliasis, monocytes increased, myocardial infarction, nephropathy, pancytopenia, peptic ulcer, pneumonia (drug-induced), pruritus, pseudomembranous colitis, renal failure (acute), respiratory failure (acute), rhabdomyolysis, serum sickness, shock, somnolence, Stevens-Johnson syndrome, stomatitis, stools abnormal, thrombocytopenia, toxic epidermal necrolysis, upper GI bleed, urine specific gravity decreased, weakness, xerostomia
Additional reactions reported with other cephalosporins: Agranulocytosis, angioedema, aplastic anemia, asterixis, encephalopathy, hemorrhage, interstitial nephritis, neuromuscular excitability, PT prolonged, seizure, superinfection, and toxic nephropathy
Hypersensitivity to cefdinir, any component of the formulation, other cephalosporins, or related antibiotics
Warnings / Precautions Drug
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.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment (Clcr <30 mL/minute); dosage adjustment may be required.
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
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 when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Exceptions: Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy Implications
Teratogenic events have not been observed in animal studies; therefore, cefdinir is classified as pregnancy category B. It is not known if cefdinir crosses the human placenta.
Excretion in breast milk unknown
Breast-Feeding Considerations
Cefdinir is not detectable in breast milk following a single cefdinir 600 mg dose. It is not known if it would be detectable after multiple doses. If present in breast milk, nondose-related effects could include modification of bowel flora.
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
Distribution: Vd:
Children 6 months to 12 years: 0.29-1.05 L/kg
Adults: 0.06-0.64 L/kg
Protein binding: 60% to 70%
Metabolism: Minimal
Bioavailability: Capsule: 16% to 21%; suspension 25%
Half-life elimination: ~100 minutes
Time to peak, plasma: 3 hours
Excretion: Primarily urine (7% to 25% as unchanged drug)
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