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Cefdinir

Physicians Total Care, Inc.

CEFDINIR FOR ORAL SUSPENSION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


CEFDINIR DESCRIPTION


1413552
Cefdinir

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
Tonsil Tissue

Sinus Tissue

Lung Tissue

Middle Ear Fluid

CSF

Metabolism and Excretion


½ Special Populations: Patients with Renal Insufficiency

DOSAGE AND ADMINISTRATION

Special Populations

Patients with Renal Insufficiency

crcrmax½crmax½ DOSAGE AND ADMINISTRATION
Hemodialysis

½ DOSAGE AND ADMINISTRATION
Hepatic Disease

Geriatric Patients

max½ Patients 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 49766
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
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



g This quality control range is applicable only to testing of H. influenzae
   ATCC 49766 using HTM.
Organism
   Zone Diameter (mm)   
   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:
PRECAUTIONS, 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 difficile
C. difficile

C. difficile
C. difficile

C. difficile C. difficile

PRECAUTIONS

General








DOSAGE AND ADMINISTRATION

Information for Patients












Drug Interactions

Antacids: (aluminum- or magnesium-containing)


® maxmax

Probenecid


½

Iron Supplements and Foods Fortified With Iron


4





Drug/Laboratory Test Interactions


®®®

Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitro in vivo 2

Pregnancy

Teratogenic effects


Pregnancy Category B

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
  a 1733 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 ADMINISTRATION OVERDOSAGE

OVERDOSAGE


CEFDINIR DOSAGE AND ADMINISTRATION


INDICATIONS AND USAGE


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 kga/95 lbs
12 mL q12h or 24 mL q24h
6 mL q12h or 12 mL q24h

Patients With Renal Insufficiency




cr

cr    (weight) (140 – age)    


cr

(3)



cr body length or height 


(4)(5)

2

2

Patients on Hemodialysis



Directions for Mixing Cefdinir for Oral Suspension
Final
   Concentration   
   Final Volume   
(mL)
   Amount of   
Water
Directions
   125 mg/5 mL   
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then 
   add water in 2 portions. Shake well   
   after each aliquot.
   250 mg/5 mL
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then 
   add water in 2 portions. Shake well   
   after each aliquot.

HOW SUPPLIED


Cefdinir for Oral Suspension 125 mg/5 mL




Cefdinir for Oral Suspension 250 mg/5 mL





Store

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/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 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.  







Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited







Physicians Total Care, Inc.

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


Rx only
                 

Cefdinir for Oral Suspension

125 mg/5 mL


SHAKE WELL BEFORE USING.




RECONSTITUTE WITH 38 mL WATER
60 mL when reconstituted


Cefdinir

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


Rx only                 

Cefdinir for Oral Suspension


250 mg/5 mL


SHAKE WELL BEFORE USING.




RECONSTITUTE WITH 38 mL WATER
60 mL when reconstituted

Cefdinir

Cefdinir

Cefdinir POWDER, FOR SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:54868-5768(NDC:65862-218)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFDINIR CEFDINIR 125 mg

Inactive Ingredients

Ingredient Name Strength
SUCROSE
SODIUM BENZOATE
SILICON DIOXIDE
XANTHAN GUM
GUAR GUM
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
MAGNESIUM STEARATE

Product Characteristics

Color
white (Off-white to Yellowish)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:54868-5768-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065473 2007-05-08


Cefdinir

Cefdinir POWDER, FOR SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:54868-5769(NDC:65862-219)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFDINIR CEFDINIR 250 mg

Inactive Ingredients

Ingredient Name Strength
SUCROSE
SODIUM BENZOATE
SILICON DIOXIDE
XANTHAN GUM
GUAR GUM
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
MAGNESIUM STEARATE

Product Characteristics

Color
white (Off-white to Yellowish)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:54868-5769-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065473 2007-05-09


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Be sure to consult your doctor before taking any medication!
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