Cefdinir for Oral Suspension USP

/Cefdinir for Oral Suspension USP
Cefdinir for Oral Suspension USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Cefdinir for Oral Suspension USP

ID:

a4587ea9-c06b-4603-beea-1ef926a4d0be

Code:

34391-3

DESCRIPTION


id: 31590cea-6cb1-4126-95c1-1562cee6c52d
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 7.0 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, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: anhydrous citric acid; colloidal silicon dioxide; guar gum; anhydrous sodium citrate; sodium benzoate; strawberry flavour; sucrose; and xanthan gum.

INDICATIONS AND USAGE


id: 92685cca-b99e-4006-9255-b6dd75702dec
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension and other antibacterial drugs, cefdinir for oral suspension 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: 27951cfb-588e-47db-b3d5-60391dd37bb3
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

WARNINGS


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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: 141aec27-6e8b-4605-a93e-250437b073d9
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: caa70406-4297-4048-a406-4995e06f563e
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 5 to 10 days
14 mg/kg q24h 10 days
Acute Maxillary Sinusitis 7 mg/kg q12h or 10 days
14 mg/kg q24h 10 days
Pharyngitis/Tonsilitis 7 mg/kg q12h or 5 to 10 days
14 mg/kg q24h 10 days
Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART
Weight  

125 
mg
/

mL 

250 
mg
/

mL 

a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
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: a9aab8ba-ce42-43e0-ab24-e70d9a9d6e2b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Cefdinir for oral suspension USP, is an off-white to creamish powder formulation that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspension has an off-white to creamish color and strawberry flavor. The powder is available as follows: 250 mg/5 mL: 100 mL bottles                                    NDC 42254-127-00 Store dry powder and reconstituted suspension at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

REFERENCES


id: d2b4cb7d-e1f7-40aa-af6d-bfb308539587
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 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.
Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Mandideep 462 046 INDIA Clinistix® and Clinitest® are registered trademarks of Miles Diagnostics. Tes-tape® is a registered trademark of Lilly. Revised December 15, 2009                                  ID#: 218627 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL


id: c32ebd37-220a-492d-bb21-b8cb0b339f90
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4