Cefdinir

Cefdinir

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Questions & Answers

Side Effects & Adverse Reactions

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

BEFORE THERAPY WITH CEFDINIR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.

Cefdinir capsules 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.

Adults and Adolescents

Community-Acquired Pneumonia

caused by Haemophilusinfluenzae (including β-lactamase producing strains), Haemophilusparainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES).

Acute Exacerbations of Chronic Bronchitis

caused by Haemophilusinfluenzae (including β-lactamase producing strains), Haemophilusparainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

Acute Maxillary Sinusitis

caused by Haemophilusinfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-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 β-lactamase producing strains) and Streptococcus pyogenes.

Pediatric Patients

Acute Bacterial Otitis Media

caused by Haemophilusinfluenzae (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 (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 β-lactamase producing strains) and Streptococcus pyogenes.

History

There is currently no drug history available for this drug.

Other Information

Cefdinir capsules contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42.

Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicone dioxide, magnesium stearate, and polyoxyl 40 stearate. The capsule shells contain FD&C Blue #2; gelatin, and titanium dioxide.

Cefdinir Manufacturers


  • Northwind Pharmaceuticals, Llc
    Cefdinir Capsule [Northwind Pharmaceuticals, Llc]
  • Blenheim Pharmacal, Inc.
    Cefdinir Capsule [Blenheim Pharmacal, Inc.]
  • Physicians Total Care, Inc.
    Cefdinir Powder, For Suspension [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Cefdinir Powder, For Suspension [Rebel Distributors Corp]
  • Lupin Pharmaceuticals Inc
    Cefdinir (Cefdinir) Capsule [Lupin Pharmaceuticals Inc]
  • Lupin Pharmaceuticals Inc
    Cefdinir (Cefdinir) Powder, For Suspension [Lupin Pharmaceuticals Inc]
  • Rebel Distributors Corp
    Cefdinir Capsule [Rebel Distributors Corp]
  • Redpharm Drug Inc.
    Cefdinir Capsule [Redpharm Drug Inc.]
  • H.j. Harkins Company, Inc.
    Cefdinir (Cefdinir) Capsule [H.j. Harkins Company, Inc.]
  • Physicians Total Care, Inc.
    Cefdinir Capsule [Physicians Total Care, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cefdinir Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Cefdinir Powder, For Suspension [Dispensing Solutions, Inc.]
  • Rebel Distributors Corp
    Cefdinir Powder, For Suspension [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Cefdinir Capsule [Rebel Distributors Corp]
  • Sandoz Inc
    Cefdinir Powder, For Suspension [Sandoz Inc]
  • Sandoz Inc
    Cefdinir Capsule [Sandoz Inc]
  • Aidarex Pharmaceuticals Llc
    Cefdinir Powder, For Suspension [Aidarex Pharmaceuticals Llc]
  • Northstar Rx Llc
    Cefdinir Powder, For Suspension [Northstar Rx Llc]
  • Northstar Rx Llc
    Cefdinir Capsule [Northstar Rx Llc]
  • Northstar Rx Llc
    Cefdinir Powder, For Suspension [Northstar Rx Llc]
  • A-s Medication Solutions Llc
    Cefdinir (Cefdinir) Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cefdinir (Cefdinir) Powder, For Suspension [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cefdinir Powder, For Suspension [A-s Medication Solutions Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Cefdinir Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Orchidpharma Inc
    Cefdinir Powder, For Suspension [Orchidpharma Inc]
  • Clinical Solutions Wholesale
    Cefdinir Powder, For Suspension [Clinical Solutions Wholesale]
  • Teva Pharmaceuticals Usa Inc
    Cefdinir Powder, For Suspension [Teva Pharmaceuticals Usa Inc]
  • Bluepoint Laboratories
    Cefdinir Capsule [Bluepoint Laboratories]
  • Aurobindo Pharma Limited
    Cefdinir Powder, For Suspension [Aurobindo Pharma Limited]
  • Dava Pharmaceuticals Inc
    Cefdinir Powder, For Suspension [Dava Pharmaceuticals Inc]
  • Dava Pharmaceuticals Inc
    Cefdinir Capsule [Dava Pharmaceuticals Inc]
  • Orchidpharma Inc
    Cefdinir Capsule [Orchidpharma Inc]
  • Citron Pharma Llc
    Cefdinir Capsule [Citron Pharma Llc]
  • Aurobindo Pharma Limited
    Cefdinir Capsule [Aurobindo Pharma Limited]
  • Northwind Pharmaceuticals, Llc
    Cefdinir Capsule [Northwind Pharmaceuticals, Llc]
  • Teva Pharmaceuticals Usa Inc
    Cefdinir Capsule [Teva Pharmaceuticals Usa Inc]
  • Preferred Pharmaceuticals Inc.
    Cefdinir Capsule [Preferred Pharmaceuticals Inc.]

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