Prescription Drug Name:

Cefdinir for Oral Suspension, USP, Rx only

ID:

ab5a8f5e-fbed-4b20-9e14-0871b5add264

Code:

34391-3

DESCRIPTION


id: 766411ef-ee45-4062-b288-3b4773052e4e
displayName: Description Section
FDA Article Code: 34089-3

Cefdinir for oral suspension, USP contains the active ingredient cefdinir USP, 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 for oral suspension, USP after reconstitution, contains 125 mg cefdinir USP per 5 mL or 250 mg cefdinir USP per 5 mL and the following inactive ingredients: sucrose, sodium benzoate, colloidal silicone dioxide, xanthan gum, guar gum, citric acid (anhydrous), sodium citrate (dihydrate), strawberry flavour, fresh cream flavour and magnesium stearate.

INDICATIONS AND USAGE


id: 1c5dc055-9fdf-4fcf-b5e1-cf6bdf214081
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 for oral suspension is 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: a9d88d97-e793-44c1-abd7-d4b88616759e
displayName: Contraindications Section
FDA Article Code: 34070-3

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

WARNINGS


id: 17339887-0185-4f63-b3cf-e9a7855e6fbf
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: aac1627b-391e-48b2-b2d7-130e7bdc52e1
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: a0585344-410a-4d5d-87ab-2872efe05aad
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 pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.

Pediatric Patients (Age 6 Months Through 12 Years)
Type of Infection Dosage Duration
   Acute Bacterial Otitis Media 7 mg/kg q12h
or
   14 mg/kg q24h    		   5 to 10 days   
10 days
   Acute Maxillary Sinusitis 7 mg/kg q12h
or
   14 mg/kg q24h    		10 days
10 days
   Pharyngitis/Tonsillitis 7 mg/kg q12h
or
   14 mg/kg q24h    		   5 to 10 days   
10 days
   Uncomplicated Skin and Skin Structure Infections       7 mg/kg q12h    10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART
aPediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg.
      Weight

 125 mg/5 mL

 250 mg/5 mL
9 kg/20 lbs 2.5 mL q12h or 5 mL q24h Use 125 mg/5 mL product
18 kg/40 lbs 5 mL q12h or 10 mL q24h 2.5 mL q12h or 5 mL q24h
27 kg/60 lbs 7.5 mL q12h or 15 mL q24h 3.75 mL q12h or 7.5 mL q24h
36 kg/80 lbs 10 mL q12h or 20 mL q24h 5 mL q12h or 10 mL q24h
 ≥ 43 kga/95 lbs 12 mL q12h or 24 mL q24h 6 mL q12h or 12 mL q24h

HOW SUPPLIED


id: 5bf1e9f5-3c14-4d4b-b074-3b1f16fc0eab
displayName: How Supplied Section
FDA Article Code: 34069-5

Cefdinir for Oral Suspension, USP 125 mg/5 mL
is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored  suspension with strawberry and cream flavors.

            60 mL Bottle                           NDC 16714-392-01
          100 mL Bottle                           NDC 16714-392-02

Cefdinir for Oral Suspension, USP 250 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored  suspension with strawberry and cream flavors.

            60 mL Bottle                           NDC 16714-393-01
          100 mL Bottle                           NDC 16714-393-02

Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

REFERENCES


id: e71dce0e-747f-4164-bd98-28226e8afbb3
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. Maalox® is a registered trademark of Rhone-Poulenc Rorer.
Clinistix® and Clinitest® are registered trademarks of Miles Diagnostics.
Tes-Tape® is a registered trademark of Eli Lilly and company.

Manufactured for:  Northstar Rx LLC
                              Memphis, TN38141.

Manufactured by:  Aurobindo Pharma Limited
                              Chitkul (V)-502 307, India.

M.L.No.: 78/MD/AP/96/F/B/R

Revised: 09/2017

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 125 mg/5 mL (60 mL Bottle)


id: a32ed700-431a-4cc5-9cf7-7e2da5e917ad
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx only
NDC 16714-392-01                 

Cefdinir for Oral
Suspension, USP 

125 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH 38 mL WATER

60 mL when reconstituted

NORTHSTARTM

 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 125 mg/5 mL (60 mL) Carton Label


id: ec101d56-1cf3-4dc1-81b7-f56e0f5ae1bf
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx only
NDC 16714-392-01
Cefdinir for Oral
Suspension, USP 

125 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH
38 mL WATER

60 mL when reconstituted

NORTHSTARTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 250 mg/5 mL (60 mL Bottle)


id: 88b4e582-e0fa-41c5-b590-5962d065026b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx only
NDC 16714-393-01
Cefdinir for Oral
Suspension, USP 
250 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH 38 mL WATER

60 mL when reconstituted
NORTHSTARTM

 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 250 mg/5 mL (60 mL) Carton Label


id: a9427de3-b2b2-41a3-8cbd-fbd285e80219
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx only
NDC 16714-393-01
Cefdinir for Oral
Suspension, USP 
250 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH
38 mL WATER

60 mL when reconstituted

NORTHSTARTM