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Omnicef (Cefdinir) - Summary

 
 



OMNICEF SUMMARY

OMNICEF® (cefdinir) capsules and OMNICEF® (cefdinir) for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF and other antibacterial drugs, OMNICEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Community-Acquired Pneumonia 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) (see CLINICAL STUDIES).

Acute Exacerbations of Chronic Bronchitis 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).

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

NOTE: For information on use in pediatric patients, See Pediatric Use and DOSAGE AND ADMINISTRATION.

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

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

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

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

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


See all Omnicef indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Omnicef (Cefdinir)

A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study. [2005.06]
BACKGROUND: Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance... CONCLUSIONS: Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Cefdinir versus levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology: a multicenter, randomized, double-blind study. [2004.12]
BACKGROUND: Treatment guidelines for acute bacterial rhinosinusitis (ABRS) recommend 10 to 14 days of therapy with high-dose amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime, cefuroxime, a macrolide, or a newer fluoroquinolone, among other agents. OBJECTIVE: This study compared the clinical efficacy and tolerability of cefdinir and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin... CONCLUSION: In this population of patients with ABRS, the extended-spectrum cephalosporin cefdinir was as efficacious as the fluoroquinolone levofloxacin, suggesting that cefdinir may be a suitable alternative to the currently recommended fluoroquinolones.

[Comparative study on cefdinir and cefaclor in the treatment of patients with mild to moderate bacterial community acquired pneumonia.] [2004.11.17]
OBJECTIVE: To evaluate the efficacy and safety of cefdinir in the treatment of patients with mild to moderate bacterial community acquired pneumonia (CAP)... CONCLUSION: cefdinir is safe and effective, shorten the course of treatment in the treatment of mild to moderate bacterial community acquired pneumonia.

Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media. [2004.09]
BACKGROUND: Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States... CONCLUSION: For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

[Clinical efficacy and bacteriological studies of clarithromycin and cefdinir against group A beta-hemolytic streptococcal tonsillopharyngitis] [2003.08]
The clinical efficacy and safety of clarithromycin (CAM) and cefdinir (CFDN) were evaluated in 65 pediatric outpatients with group A beta-hemolytic streptococcal tonsillopharyngitis. Treatment was "effective" or better in 26 (78.8%) children receiving CAM and in 27 (87.1%) receiving CFDN based on antigen clearance and the "Criteria for Evaluation in Clinical Trials of Antibacterial Agents in Children" proposed by Japan Society of Chemotherapy (p = NS)...

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Clinical Trials Related to Omnicef (Cefdinir)

Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications [Completed]
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It was designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications [Completed]
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications [Completed]
To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis [Completed]

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media [Completed]
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

more trials >>

Reports of Suspected Omnicef (Cefdinir) Side Effects

Rash (7)Diarrhoea (6)Clostridium Difficile Colitis (5)Sinusitis (4)Hypersensitivity (3)Drug Ineffective (3)Urticaria (3)Headache (2)Pyrexia (2)Faeces Discoloured (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 12 ratings/reviews, Omnicef has an overall score of 1.83. The effectiveness score is 6.50 and the side effect score is 2.83. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Omnicef review by 58 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   sore throat
Dosage & duration:   300 mg taken twice a day for the period of 10 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The treatment cured the sore throat for which it was perscribed.
Side effects:   During the 10 days taking the drug there were no side effects, however the day after the last dosage, I began having severe diarrhea, which persisted and was diagnosed as a bacterial infection called clostridium difficil, caused by the antibiotic I had taken.
Comments:   I took omnicef orally for 10 days. After the clostridium difficil was diagnosed, I had to start a new course of drugs which had to be repeated before the new infection/condition was cured.

 

Omnicef review by care giver of 5 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   strep throat
Dosage & duration:   13cc suposed to be 6cc (dosage frequency: recommended) for the period of 3 days
Other conditions:   twitching of eyes
Other drugs taken:   none
  
Reported Results
Benefits:   very upset
Side effects:   first twitching of eyes went into body tremors than to seizures
Comments:   after noticing eyes twitching went back to peditrican said it was something else called pandas associated with strep throat but sympthoms got worse going to hospital because of having seizure like episodes took off medicine we nt away for 2 years but are still suffering from effects of seizure like episodes but neurologist exams say not seizures but dont know what they are i still believe it was the drug all started with the overdose brenda n son

 

Omnicef review by care giver of 3 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Sinus infection
Dosage & duration:   5 ml 1x daily for 10 days (dosage frequency: once a day after breakfast) for the period of 3 doses total
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   This drug was prescribed because my daughter has had adverse side effects from penicillin based antibiotics (trunk rash/hives from amoxicillin for an ear infection). She had a sinus infection that we couldn't get rid of with natural remedies (salt water flush, tea, elevated sleeping) so we went the antibiotic route.
Side effects:   Her side effects were almost immediate thoug it took my husband and I 3 doses (3 days) to figure it out. For an almost three year old, her moods were fairly predictable. She was irritable when she was hungry, tired, or needed to poop. But about 24 hours after her first dose of Cefdinir! Her moods drastically changed to violent, out-of-control, scary, temper tantrums. To the point where she was biting herself, Banging her head on the wall and hitting and kicking us with all her might. And when we would try and stop her, it was like she didn't recognize us and would get scared and cry. It was disturbing and very upsetting for us a parents. We started doing research the next day and little info on the drug except for druglib.com and the official side effect page. We found drastic mood changes buried in the side effects information and discontinued use. Our doctor didn't seem that concerned even after we explained the scary details. He prescribed aZ Pack for her symptoms and she has been fine ever since (we have a new doctor now though).
Comments:   Our daughter completed her treatment with a z pack.

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Page last updated: 2006-01-31

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