CEFDINIR FOR ORAL SUSPENSION

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Prescription Drug Name:

ID:

c21f3dae-e96c-49ee-8177-c9dba8ee73ad

Code:

34391-3

DESCRIPTION

id: 04855582-be54-43a5-81bf-cc6084572238
displayName: Description Section
FDA Article Code: 34089-3

Cefdinir for oral suspension 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 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, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir 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: 07afc08b-ad61-4f81-bb9f-865221f4e011
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: fabca49f-59f5-41d0-87e3-24ff28c8cd96
displayName: Contraindications Section
FDA Article Code: 34070-3

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

WARNINGS

id: 762bd733-2cbe-44c4-ac66-27a1a0833f7e
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: 6d066556-0e1b-4939-9a42-3b32bedb7471
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-lactame 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: f5280f8c-50d3-47d0-be04-50be913c3881
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
^a Pediatric patients who weight ≥ 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 kg^a/95 lbs	12 mL q12h or 24 mL q24h	6 mL q12h or 12 mL q24h

HOW SUPPLIED

id: 42d4f44e-a414-4bb0-a6bc-a26cc723116f
displayName: How Supplied Section
FDA Article Code: 34069-5

Cefdinir for Oral Suspension 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 54868-5768-0
100 mL Bottle NDC 54868-5768-1

Cefdinir for Oral Suspension 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 54868-5769-0
100 mL Bottle NDC 54868-5769-1

Store dry powder 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]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

REFERENCES

id: d187f187-60e6-4835-861e-80c509665c28
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

Issued: October 2007

Relabeling of “Additional Barcode” label by:
Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

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

id: f14b5111-96fd-44e9-be04-f7f13baab929
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx only

Cefdinir for Oral Suspension

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

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

id: 3325c215-07d2-4d1c-ae65-0903d7c54149
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4