Cefdinir For Oral Suspension

— THERAPEUTIC CATEGORIES —
  • Bacterial infections
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cefdinir For Oral Suspension Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Cefdinir 125mg/5mL, 250mg/5mL; pwd for reconstitution; strawberry-cream flavor.

    Pharmacological Class

    Cephalosporin.

    See Also

    How Supplied

    Contact supplier.

    Storage

    Cefdinir capsules:

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Cefdinir for Oral Suspension:

    Store the unsuspended powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

     

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir.

    Cefdinir For Oral Suspension Indications

    Indications

    Susceptible mild-to-moderate infections, including community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, acute otitis media.

    Indications

    Treatment of patients with mild-to-moderate infections caused by susceptible strains of the designated microorganisms for the following conditions.

    Adults and Adolescents

    Community-Acquired Pneumonia: caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Acute Exacerbations of Chronic Bronchitis: caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Acute Maxillary Sinusitis: caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Pharyngitis/Tonsillitis: caused by Streptococcus pyogenes.

    Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

     

    Pediatric Patients

    Acute Bacterial Otitis Media: caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Pharyngitis/Tonsillitis: caused by Streptococcus pyogenes.

    Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

    Cefdinir For Oral Suspension Dosage and Administration

    Adult

    Use caps. ≥13yrs: Pneumonia, skin and skin structure: 300mg every 12hrs for 10 days. Bronchitis, pharyngitis/tonsillitis: 300mg every 12hrs for 5–10 days, or 600mg every 24hrs for 10 days. Sinusitis: 300mg every 12hrs, or 600mg every 24hrs, for 10 days. Renal insufficiency (CrCl <30mL/min): 300mg once daily. Hemodialysis: 300mg (or 7mg/kg) at end of session then 300mg (or 7mg/kg) every other day.

    Children

    Use susp. <6months: not recommended. 6months–12yrs: Otitis media, pharyngitis/tonsillitis: 7mg/kg every 12hrs for 5–10 days, or 14mg/kg every 24hrs for 10 days. Sinusitis: 7mg/kg every 12hrs, or 14mg/kg every 24hrs, for 10 days. Skin and skin structure: 7mg/kg every 12hrs for 10 days. For all: max 600mg/day; see literature for chart. Renal insufficiency (CrCl <30mL/min per 1.73m2): 7mg/kg (max 300mg) once daily. Hemodialysis: give initial and subsequent doses at end of session (see literature).

    Cefdinir For Oral Suspension Contraindications

    Not Applicable

    Cefdinir For Oral Suspension Boxed Warnings

    Not Applicable

    Cefdinir For Oral Suspension Warnings/Precautions

    Warnings/Precautions

    Penicillin or other allergy. Renal insufficiency. History of colitis. Labor & delivery. Pregnancy (Cat.B).

    Warnings/Precautions

    • Carefully inquire patients if they have had previous hypersensitivity reactions to Cefdinir, other cephalosporins, penicillins, or other drugs. Use caution in penicillin-sensitive patients due to cross-hypersensitivity. Discontinue if an allergic reaction to Cefdinir occurs.

    • Clostridium difficile associated diarrhea (CDAD) has been reported. CDAD must be considered in all patients who present with diarrhea after antibacterial use.

    • Prescribe Cefdinir with caution in individuals with a history of colitis. 

    • Reduce daily dose of Cefdinir in patients with transient or persistent renal impairment (CrCl < 30mL/min).

    Pregnancy Considerations

    Teratogenic Effects

    • There are no adequate and well-controlled studies in pregnant women.

    Labor Delivery

    • Not studied for use during labor and delivery.

     

    Nursing Mother Considerations

    Cefdinir was not detected in human breast milk.

    Pediatric Considerations

    The safety and efficacy of Cefdinir in neonates and infants less than 6 months of age have not been established.

    Geriatric Considerations

    Efficacy is comparable in geriatric patients and younger adults.

    Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised.

    Cefdinir For Oral Suspension Pharmacokinetics

    Elimination

    Renal. Half-life: ~1.7 hours.

    Cefdinir For Oral Suspension Interactions

    Interactions

    Antagonized by magnesium- or aluminum-containing antacids or iron supplements (except iron-fortified infant formulas): separate dosing by 2hrs. Potentiated by probenecid. May cause false (+) glucose test with Clinitest, Fehling's or Benedict's soln, or direct Coomb's test.

    Cefdinir For Oral Suspension Adverse Reactions

    Adverse Reactions

    GI disturbances, abdominal pain, headache, rash.

    Cefdinir For Oral Suspension Clinical Trials

    Clinical Trials

    Community-Acquired Bacterial Pneumonia

    • A controlled, double-blind US study compared the efficacy and safety of Cefdinir twice daily with cefaclor 500mg three times daily in adults and adolescents. The clinical cure and eradication rates for the Cefinidir treatment arm were equivalent to the control arm, using strict evaluability and microbiologic/clinical response criteria 6 to 14 days post therapy.

    • A second controlled, investigator-blind study compared the efficacy and safety of Cefdinir twice daily with amoxicillin/clavulanate 500/125mg three times daily. The clinical cure rates for the Cefdinir treatment arm were not equivalent to the control, while the eradication rates were equivalent, using strict evaluability and microbiologic/clinical response criteria 6 to 14 days post therapy.

    Streptococcal Pharyngitis/Tonsillitis

    • 4 controlled US studies compared Cefdinir to penicillin in adult, adolescent, and pediatric patients for 10 days. 

      • In 2 studies (1 in adults and adolescents, the other in pediatric patients), Cefdinir twice daily was compared to penicillin 250mg or 10mg/kg four times daily for 10 days. The clinical cure and eradication rates for the cefdinir treatment arm were equivalent to the control arm.

    Cefdinir For Oral Suspension Note

    Notes

    Formerly known under the brand name Omnicef.

    Cefdinir For Oral Suspension Patient Counseling

    Patient Counseling

    • Counsel patients that antibacterial drugs such as Cefdinir should only be used to treat bacterial infections.

    • Advise patients that while it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

    • Antacids containing magnesium or aluminum and iron supplements, including multivitamins that contain iron, interfere with the absorption of Cefdinir. If unavoidable, then give Cefdinir at least 2 hours before or after the antacid or supplement.

    • Inform diabetic patients and caregivers that the oral suspension contains sucrose.

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