Cefdinir Capsules, USP, Rx only

/Cefdinir Capsules, USP, Rx only
Cefdinir Capsules, USP, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Cefdinir Capsules, USP, Rx only

ID:

df4e3753-5702-409c-bd2a-f6678e4f9199

Code:

34391-3

DESCRIPTION


id: 49801df9-794f-485d-9c5a-a73a46318ba3
displayName: Description Section
FDA Article Code: 34089-3

Cefdinir capsules, USP 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 USP 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 molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below: Cefdinir capsules, USP contain 300 mg cefdinir USP 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: 2408fa78-7d1e-4e38-85fc-086db9045a19
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, USP 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: 70f24180-c6c9-45bb-abbf-e5d18cb5ab5b
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: 02d34218-9b2e-4b00-a451-75b19140d44c
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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

OVERDOSAGE


id: e8ec55dd-a169-49c6-a033-24147d8ef2a8
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: 90428c62-723c-49dd-b72f-598ba49a0570
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: 3a304c8d-0ed0-4eb5-891f-8d2e8c951e0b
displayName: How Supplied Section
FDA Article Code: 34069-5

Product: 50090-2719 NDC: 50090-2719-1 20 CAPSULE in a BOTTLE NDC: 50090-2719-2 14 CAPSULE in a BOTTLE NDC: 50090-2719-3 30 CAPSULE in a BOTTLE

REFERENCES


id: 06923f13-3ee3-4e63-8957-eebe2da037e3
displayName: References Section
FDA Article Code: 34093-5

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Tenth Edition. CLSI Document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI Document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI Document M100-S25 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum 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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Distributed by:
Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816 Code No.: AP/DRUGS/78/96 Made in India Revised: 01/2016

Cefdinir


id: d3e07fda-b5cb-463a-af32-fc17912d05cb
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4