CEFDINIR CAPSULES USP

/CEFDINIR CAPSULES USP
CEFDINIR CAPSULES USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

CEFDINIR CAPSULES USP

ID:

87d34363-b17b-439f-bf91-33e2738aea9e

Code:

34391-3

DESCRIPTION


id: f5470e5a-a547-426b-877d-6e0e616f108b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Cefdinir capsules contains 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 molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:  Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide. 

INDICATIONS AND USAGE


id: 488f9507-c337-431b-adc6-7c8a47488a32
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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: d8147db8-2cda-42df-986f-7704cf057f29
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

WARNINGS


id: 96315a00-05c3-4363-8562-87f5b1c0c098
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: 9c7ebbfc-91b9-4789-9d2d-903a8a45c87d
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: 03172559-86dc-4937-b5bc-96230629c806
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  5 to 10 days
or
Acute Maxillary Sinusitis  600 mg q24h  10 days
300 mg q12h  10 days
or
Pharyngitis/Tonsillitis  600 mg q24h  10 days
300 mg q12h  5 to 10 days
or
Uncomplicated Skin and Skin Structure Infections  600 mg q24h  10 days
300 mg q12h  10 days

HOW SUPPLIED


id: ce8c8998-4ce4-472f-ba38-9a2a87292baf
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Cefdinir capsules USP, 300 mg, size ‘0’ capsules having blue cap imprinted twice with “LUPIN” (in black ink) and purple body imprinted twice with “CEFDINIR” (in white ink) containing off white to creamish granular slug, are available as follows: 60 Capsules/Bottle                                 NDC 68180-711-60 Store the capsules at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

REFERENCES


id: e332021f-d267-4a50-a279-95371ab99113
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.

PRINCIPAL DISPLAY PANEL


id: a72dfb7d-6843-4424-80ea-0f0282016e26
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

CEFDINIR CAPSULES USP Rx Only 300 mg NDC 68180-711-60 60 Capsules