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Cefdinir

Northstar Rx LLC
Aurobindo Pharma Limited

Cefdinir Capsules, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


CEFDINIR DESCRIPTION


1413552
Cefdinir

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.

CLINICAL PHARMACOLOGY

Pharmacokinetics and Drug Metabolism

Absorption

Oral Bioavailability

Effect of Food

maxmax
Cefdinir Capsules


Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Capsules to Adult Subjects
Dose Cmax
(mcg/mL) 		tmax
(hr)		 AUC
(mcg•hr/mL)
   300 mg
1.6
(0.55)
 2.9
(0.89)
 7.05
(2.17)
   600 mg
2.87
(1.01)
 3
(0.66)
 11.1
(3.87)
Cefdinir Suspension


Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects
Dose Cmax
(mcg/mL) 		tmax
(hr)		 AUC
(mcg•hr/mL)
   7 mg/kg
2.3
(0.65)
 2.2
(0.6)
 8.31
(2.5)
   14 mg/kg
3.86
(0.62)
 1.8
(0.4)
 13.4
(2.64)
Multiple Dosing

Distribution


areaarea
Skin Blister

max(0-∞)
Tonsil Tissue

Sinus Tissue

Lung Tissue

Middle Ear Fluid

CSF

Metabolism and Excretion


½Special Populations: Patients with Renal Insufficiency

DOSAGE AND ADMINISTRATION

Special Populations

Patients with Renal Insufficiency

crcrmax½crmax½ DOSAGE AND ADMINISTRATION
Hemodialysis

½DOSAGE AND ADMINISTRATION
Hepatic Disease

Geriatric Patients

max½Patients with Renal Insufficiency
Gender and Race

Microbiology




in vitro INDICATIONS AND USAGE

Aerobic Gram-Positive Microorganisms


Staphylococcus aureus

Streptococcus pneumoniae
Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms


Haemophilus influenzae
Haemophilus parainfluenzae
Moraxella catarrhalis

in vitro but their clinical significance is unknown

in vitro

Aerobic Gram-Positive Microorganisms


Staphylococcus epidermidis
Streptococcus agalactiae


Enterococcus Staphylococcus

Aerobic Gram-Negative Microorganisms


Citrobacter diversus
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis

Pseudomonas Enterobacter

Susceptibility Tests

Dilution Techniques


(1)

Haemophilus Streptococcus
MIC (mcg/mL) Interpretation
≤1
 Susceptible (S)
2
 Intermediate (I)
≥4
 Resistant (R)

Haemophilus a
MIC (mcg/mL) Interpretationb
a These interpretive standards are applicable only to broth microdilution susceptibility tests with Haemophilus spp. using Haemophilus Test Medium (HTM).(1)
b The current absence of data on resistant strains precludes defining any results other than “Susceptible.” Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
≤1
 Susceptible (S)

Streptococcus

Streptococcus pneumoniae S. pneumoniae




Microorganism   MIC Range (mcg/mL) 
c This quality control range is applicable only to H. influenzae ATCC 49766 tested by a broth microdilution procedure using HTM.
  Escherichia coli ATCC 25922
 0.12-0.5
  Haemophilus influenzae ATCC 49766c 
0.12-0.5
  Staphylococcus aureus ATCC 29213
 0.12-0.5

Diffusion Techniques


(2)



Haemophilus Streptococcus d
Zone Diameter (mm) Interpretation
d Because certain strains of Citrobacter, Providencia, and Enterobacter spp. have been reported to give false susceptible results with the cefdinir disk, strains of these genera should not be tested and reported with this disk.
≥20
 Susceptible (S)
17-19
 Intermediate (I)
≤16
 Resistant (R)

Haemophilus e
Zone Diameter (mm) Interpretationf
e  These zone diameter standards are applicable only to tests with Haemophilus spp. using HTM.(2)
f  The current absence of data on resistant strains precludes defining any results other than “Susceptible.” Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
≥20
 Susceptible (S)

Streptococcus

Streptococcus pneumoniae S. pneumoniae


Organism    Zone Diameter (mm)   
g This quality control range is applicable only to testing of H. influenzae ATCC 49766 using HTM.
   Escherichia coli ATCC 25922
24-28
   Haemophilus influenzae ATCC 49766g   
24-31
   Staphylococcus aureus ATCC 25923
25-32

CEFDINIR INDICATIONS AND USAGE




Adults and Adolescents


Community-Acquired Pneumonia Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES

Acute Exacerbations of Chronic Bronchitis Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis

Acute Maxillary Sinusitis Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis

NOTE: Pediatric Use  DOSAGE AND ADMINISTRATION

Pharyngitis/Tonsillitis Streptococcus pyogenes CLINICAL STUDIES

NOTE: S. pyogenes S. pyogenes

Uncomplicated Skin and Skin Structure Infections Staphylococcus aureus Streptococcus pyogenes

Pediatric Patients


Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis

Pharyngitis/Tonsillitis Streptococcus pyogenes CLINICAL STUDIES

NOTE: S. pyogenes S. pyogenes

Uncomplicated Skin and Skin Structure Infections Staphylococcus aureus Streptococcus pyogenes

CEFDINIR CONTRAINDICATIONS


WARNINGS


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 difficileC. difficile

C. difficileC. difficile

C. difficile C. difficile

PRECAUTIONS

General








DOSAGE AND ADMINISTRATION

Information for Patients










Drug Interactions

Antacids (aluminum- or magnesium-containing)

Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.

Probenecid


½

Iron Supplements and Foods Fortified With Iron


4





Drug or Laboratory Test Interactions


®® ®

Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitro in vivo 2

Pregnancy

Teratogenic Effects




22

Labor and Delivery


Nursing Mothers


Pediatric Use


Geriatric Use


DOSAGE AND ADMINISTRATION

CEFDINIR ADVERSE REACTIONS

Clinical Trials - Cefdinir Capsules (Adult and Adolescent Patients)





ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES
U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)a
a1733 males, 2108 females
Incidence ≥1%
 Diarrhea 15%
Vaginal moniliasis 4% of Women
Nausea 3%
Headache 2%
Abdominal pain 1%
Vaginitis 1% of Women
Incidence <1% but >0.1%
Rash 0.9%
Dyspepsia 0.7%
Flatulence 0.7%
Vomiting 0.7%
Abnormal stools 0.3%
Anorexia 0.3%
Constipation 0.3%
Dizziness 0.3%
Dry mouth 0.3%
Asthenia 0.2%
Insomnia 0.2%
Leukorrhea 0.2% of Women
Moniliasis 0.2%
Pruritus 0.2%
Somnolence 0.2%




LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES
U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS
(N = 3841)
a N <3841 for these parameters
Incidence ≥1%
 ↑Urine leukocytes 2%
↑Urine protein 2%
↑Gamma-glutamyltransferasea 1%
↓Lymphocytes, ↑Lymphocytes 1%, 0.2%
↑Microhematuria 1%
Incidence <1% but >0.1%
↑Glucosea 0.9%
↑Urine glucose 0.9%
↑White blood cells, ↓White blood cells 0.9%, 0.7%
↑Alanine aminotransferase (ALT) 0.7%
↑Eosinophils 0.7%
↑Urine specific gravity, ↓Urine specific gravitya 0.6%, 0.2%
↓Bicarbonatea 0.6%
↑Phosphorus, ↓Phosphorusa 0.6%, 0.3%
↑Aspartate aminotransferase (AST) 0.4%
↑Alkaline phosphatase 0.3%
↑Blood urea nitrogen (BUN) 0.3%
↓Hemoglobin 0.3%
↑Polymorphonuclear neutrophils (PMNs), ↓PMNs 0.3%, 0.2%
↑Bilirubin 0.2%
↑Lactate dehydrogenasea 0.2%
↑Platelets 0.2%
↑Potassiuma 0.2%
↑Urine pHa 0.2%



Clinical Trials - Cefdinir for Oral Suspension (Pediatric Patients)





   ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION   
U.S. TRIALS IN PEDIATRIC PATIENTS
(N = 1783)a
a 977 males, 806 females
b Laboratory changes were occasionally reported as adverse events.
   Incidence ≥ 1%
    Diarrhea
 8%
   Rash
 3%
   Vomiting
 1%
   Incidence <1% but >0.1%   
    Cutaneous moniliasis
 0.9%
   Abdominal pain
 0.8%
   Leukopeniab
0.3%
   Vaginal moniliasis
    0.3% of girls   
   Vaginitis
    0.3% of girls   
   Abnormal stools
 0.2%
   Dyspepsia
 0.2%
   Hyperkinesia
 0.2%
   Increased ASTb
0.2%
   Maculopapular rash
 0.2%
   Nausea
 0.2%




LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL
SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION
U.S. TRIALS IN PEDIATRIC PATIENTS
(N = 1783)
a N = 1387 for these parameters
   Incidence ≥1%
    ↑Lymphocytes, ↓Lymphocytes
   2%, 0.8%   
   ↑Alkaline phosphatase
 1%
   ↓Bicarbonatea
1%
   ↑Eosinophils
 1%
   ↑Lactate dehydrogenase
 1%
   ↑Platelets
 1%
   ↑PMNs, ↓PMNs
 1%, 1%
   ↑Urine protein
 1%
   Incidence <1% but >0.1%   
    ↑Phosphorus, ↓Phosphorus
    0.9%, 0.4%   
   ↑Urine pH
 0.8%
   ↓White blood cells, ↑White blood cells
    0.7%, 0.3%   
   ↓Calciuma
0.5%
   ↓Hemoglobin
 0.5%
   ↑Urine leukocytes
 0.5%
   ↑Monocytes
 0.4%
   ↑AST
 0.3%
   ↑Potassiuma
0.3%
   ↑Urine specific gravity, ↓Urine specific gravity   
    0.3%, 0.1%   
   ↓Hematocrita
0.2%

Postmarketing Experience


Cephalosporin Class Adverse Events




WARNINGS

DOSAGE AND ADMINISTRATIONOVERDOSAGE

OVERDOSAGE


CEFDINIR DOSAGE AND ADMINISTRATION


INDICATIONS AND USAGE


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

Patients With Renal Insufficiency




cr

cr    (weight) (140 – age)    


cr

(3)



cr body length or height 


(4)(5)

2

2

Patients on Hemodialysis


HOW SUPPLIED


Cefdinir Capsules, USP 300 mg




Store at

CLINICAL STUDIES

Community-Acquired Bacterial Pneumonia


U.S. Community-Acquired Pneumonia Study Cefdinir vs Cefaclor
Cefdinir BID Cefaclor TID Outcome
   Clinical Cure Rates
150/187 (80%)
147/186 (79%)
Cefdinir equivalent to control
   Eradication Rates
   Overall
 177/195 (91%)
184/200 (92%)
Cefdinir equivalent to control
   S. pneumoniae
31/31 (100%)
35/35 (100%)
   H. influenzae
55/65 (85%)
60/72 (83%)
   M. catarrhalis
10/10 (100%)
11/11 (100%)
   H. parainfluenzae
81/89 (91%)
78/82 (95%)

European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate
Cefdinir BID Amoxicillin/Clavulanate
TID		 Outcome
   Clinical Cure Rates
83/104 (80%)
86/97(89%)
 Cefdinir not equivalent to control
   Eradication Rates
   Overall
85/96 (89%)
84/90 (93%)
 Cefdinir equivalent to control
   S. pneumoniae
42/44 (95%)
43/44 (98%)
   H. influenzae
26/35 (74%)
21/26 (81%)
   M. catarrhalis
6/6 (100%)
8/8 (100%)
   H. parainfluenzae
11/11 (100%)
12/12 (100%)

Streptococcal Pharyngitis or Tonsillitis


Pharyngitis/Tonsillitis Studies Cefdinir (10 days) vs Penicillin (10 days)
Study Efficacy Parameter Cefdinir QD Cefdinir BID Penicillin QID Outcome
   Adults/Adolescents
Eradication of S. pyogenes
192/210 (91%)
199/217 (92%)
181/217 (83%)
Cefdinir superior to control
Clinical Cure Rates
 199/210 (95%)
209/217 (96%)
193/217 (89%)
Cefdinir superior to control
   Pediatric Patients
Eradication of S. pyogenes
215/228 (94%)
214/227 (94%)
159/227 (70%)
Cefdinir superior to control
Clinical Cure Rates
 222/228 (97%)
218/227 (96%)
196/227 (86%)
Cefdinir superior to control


Pharyngitis/Tonsillitis Studies Cefdinir (5 days) vs Penicillin (10 days)
Study Efficacy Parameter Cefdinir BID Penicillin QID Outcome
   Adults/Adolescents
Eradication of S. pyogenes
193/218 (89%)
 176/214 (82%)
 Cefdinir equivalent to control
Clinical Cure Rates
 194/218 (89%)
 181/214 (85%)
 Cefdinir equivalent to control
   Pediatric Patients
Eradication of S. pyogenes
176/196 (90%)
 135/193 (70%)
 Cefdinir superior to control
Clinical Cure Rates
 179/196 (91%)
 173/193 (90%)
 Cefdinir equivalent to control

REFERENCES



  • 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.  

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Manufactured for: Northstar Rx LLC
                                 Memphis, TN 38141
                                 Toll Free: 1-800-206-7821







Issued: 01/2013

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (30 Capsule Bottle)


Rx only
NDC 16714-391-01
Cefdinir Capsules, USP
300 mg
30 Capsules
Northstar Rx LLC
Cefdinir

Cefdinir

Cefdinir CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-391
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFDINIR CEFDINIR 300 mg

Inactive Ingredients

Ingredient Name Strength
carboxymethylcellulose calcium
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
D&C RED NO. 28
titanium dioxide
GELATIN
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
TURQUOISE (Turquoise Opaque) 21 mm E99 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-391-01 30 in 1 BOTTLE
2 NDC:16714-391-02 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065434 2008-01-07


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