Cefdinir Capsules

/Cefdinir Capsules
Cefdinir Capsules2018-09-06T09:12:40+00:00

Prescription Drug Name:

Cefdinir Capsules

ID:

a84712bf-221d-4366-9cf0-b8c19428c276

Code:

34391-3

DESCRIPTION


id: 161bf709-3346-4f1f-bba6-d7f125e54c2e
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 phosphate buffer. The molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below: Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.

INDICATIONS AND USAGE


id: 55a9cf48-2e57-423d-9382-9880b44f8667
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: 6445938f-6227-4371-9877-dc619448207c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Cefdinir capsules are contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

WARNINGS


id: 9f1a503e-77b8-4bfb-b8da-61065057d5fd
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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.

OVERDOSAGE


id: afb12d8e-28ae-490d-8b8d-3345cf600b6b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

DOSAGE AND ADMINISTRATION


id: 0473c966-8e46-49f1-aa2f-1b8ff81ef22d
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

(see INDICATIONS AND USAGE for Indicated Pathogens) The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.

Adults and Adolescents (Age 13 Years and Older)
Type of Infection Dosage Duration
   Community-Acquired Pneumonia 300 mg q12h 10 days
   Acute Exacerbations of Chronic Bronchitis
 
 
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis
 
 
300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis
 
 
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days

HOW SUPPLIED


id: 2d9f67d2-6129-43be-b289-d5b881c21c0b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Cefdinir Capsules 300 mg are lavender opaque/turquoise opaque size ‘0’ hard gelatin capsule filled with off-white to yellow powder and imprinted with ‘E99’ on turquoise opaque body with black ink.         Bottles of 20                 NDC 21695-620-20 

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

REFERENCES


id: 017591ac-07b0-407d-83c7-213c89af08ab
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 4th ed. Approved Standard, NCCLS Document M7-A4, Vol 17(2) NCCLS, Villanova, PA, Jan 1997. 
National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, 6th ed. Approved Standard, NCCLS Document M2-A6, Vol 17(1). NCCLS, Villanova, PA, Jan 1997. 
Cockcroft DW, Gault MH. Prediction of creatinine clearance from secum creatinine, Nephron 1976;16:31-41. 
Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.
Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.  

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Manufactured for:
Aurobindo Pharma USA, Inc.

2400 Route 130 North
Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Chitkul (V)-502 307, A.P., India   Revised: 12/2008 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Principal Display Panel


id: 63d65af8-9040-46c4-9ea4-36895296e6f4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4