CEFPODOXIME PROXETIL

PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.

Cefpodoxime Proxetil Tablets, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• CEFPODOXIME PROXETIL DESCRIPTION
• CLINICAL PHARMACOLOGY
  • Absorption and Excretion
  • Effects of Food
  • Pharmacokinetics of Cefpodoxime Proxetil Film-coated Tablets
  • Pharmacokinetics of Cefpodoxime Proxetil Suspension
  • Distribution
  • Effects of Decreased Renal Function
  • Effect of Hepatic Impairment (cirrhosis)
  • Pharmacokinetics in Elderly Subjects
  • Microbiology
• CEFPODOXIME PROXETIL INDICATIONS AND USAGE
• CEFPODOXIME PROXETIL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Drug Interactions
  • Drug/Laboratory Test Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• CEFPODOXIME PROXETIL ADVERSE REACTIONS
  • Clinical Trials
  • Laboratory Changes
  • Post-marketing Experience
  • Cephalosporin Class Labeling
• OVERDOSAGE
• CEFPODOXIME PROXETIL DOSAGE AND ADMINISTRATION
  • FILM-COATED TABLETS
  • GRANULES FOR ORAL SUSPENSION
  • Patients with Renal Dysfunction
  • Patients with Cirrhosis
• HOW SUPPLIED
• REFERENCES
• CLINICAL TRIALS
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)

FULL PRESCRIBING INFORMATION

CEFPODOXIME PROXETIL DESCRIPTION

CLINICAL PHARMACOLOGY

Absorption and Excretion

Effects of Food

Pharmacokinetics of Cefpodoxime Proxetil Film-coated Tablets

Pharmacokinetics of Cefpodoxime Proxetil Suspension

Distribution

Skin Blister

Tonsil Tissue

Lung Tissue

CSF

Effects of Decreased Renal Function

Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (<50 mL/min creatinine clearance). (See PRECAUTIONS and DOSAGE AND ADMINISTRATION.) In subjects with mild impairment of renal function (50 to 80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours. In subjects with moderate (30 to 49 mL/min creatinine clearance) or severe renal impairment (5 to 29 mL/min creatinine clearance), the half-life increased to 5.9 and 9.8 hours, respectively. Approximately 23% of the administered dose was cleared from the body during a standard 3-hour hemodialysis procedure.

Effect of Hepatic Impairment (cirrhosis)

Pharmacokinetics in Elderly Subjects

Microbiology

SUSCEPTIBILITY TESTING

₂^2
n  

For Susceptibility Testing of Streptococcus pneumoniae. <sup>o



o</sup>S. pneumoniae₂²

For Susceptibility Testing of Streptococcus spp. other than Streptococcus pneumoniae.<sup>p



p</sup>Streptococcus spp.₂²

Quality Control



Microorganism (ATCC^®#)Zone Diameter Range (mm)
Escherichia coli
Staphylococcus aureus
Haemophilus influenzae^q
Neisseria gonorrhoeae^r
Streptococcus pneumoniae<sup>ts

q</sup>  ₂
^r  ₂
^s  ₂
^t  S. pneumoniae Streptococcus spp.

^®

CEFPODOXIME PROXETIL INDICATIONS AND USAGE

Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis mediaStreptococcus pneumoniaeStreptococcus pyogenesHaemophilus influenzaeMoraxella (Branhamella)catarrhalis

Pharyngitis and/or tonsillitis Streptococcus pyogenes

NOTE:

Community-acquired pneumoniaS. pneumoniae H. Influenzae

Acute bacterial exacerbation of chronic bronchitisS. pneumoniaeH. influenzae M. catarrhalisH. influenzae

Acute, uncomplicated urethral and cervical gonorrheaNeisseria gonorrhoeae

Acute, uncomplicated ano-rectal infections in womenNeisseria gonorrhoeae

NOTE: N. gonorrhoeaeN. gonorrhoeae

Uncomplicated skin and skin structure infectionsStaphylococcus aureusStreptococcus pyogenes

NOTE: DOSAGE AND ADMINISTRATION

Acute maxillary sinusitisHaemophilus influenzae Streptococcus pneumoniaeMoraxella catarrhalis

Uncomplicated urinary tract infections (cystitis)Escherichia coli, Klebsiella pneumoniae, Proteus mirabilisStaphylococcus saprophyticus

NOTE: CLINICAL STUDIES

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil 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.

CEFPODOXIME PROXETIL CONTRAINDICATIONS

WARNINGS

BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-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 CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile C. difficile

C. difficile C. difficile

C. difficileC. difficile

C. difficile C. difficileC. difficile

PRECAUTIONS

General

DOSAGE AND ADMINISTRATION

Information for Patients

Drug Interactions

Antacids:_2max

Probenecid:

Nephrotoxic drugs:

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

in vivo²

Pregnancy

Teratogenic effects

²²

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

CEFPODOXIME PROXETIL ADVERSE REACTIONS

Clinical Trials

Film-coated Tablets (Multiple dose)

multiple doses

Incidence Greater Than 1%



C. difficile WARNINGS







Incidence Less Than 1%: By body system in decreasing order:

Clinical Studies

Adverse events thought possibly or probably related to cefpodoxime proxetil that occurred in less than 1% of patients (N=4696)

Body

Cardiovascular

Digestive

Hemic and Lymphatic

Metabolic and Nutritional

Musculo-skeletal

Nervous

Respiratory

Skin

Special Senses

Urogenital

Granules for Oral Suspension (Multiple dose)

Incidence Greater Than 1%:












Incidence Less Than 1%:

Body:

Digestive:

Hemic & Lymphatic:

Metabolic & Nutritional:

Musculo-Skeletal:

Nervous:

Respiratory:

Skin:

Special Senses:

Film-coated Tablets (Single dose)

 single dose



Incidence Greater Than 1%:




Incidence Less Than 1%:

Central Nervous System:
Dermatologic:
Genital:
Gastrointestinal:
Psychiatric:

Laboratory Changes

Hepatic:

Hematologic:

Serum Chemistry:

Renal:

Post-marketing Experience

Cephalosporin Class Labeling

Adverse Reactions and Abnormal Laboratory Tests:

DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE

CEFPODOXIME PROXETIL DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE for indicated pathogens.)

FILM-COATED TABLETS

CLINICAL PHARMACOLOGY

Adults and Adolescents (age 12 years and older)

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Pharyngitis and/or tonsillitis	200 mg	100 mg Q 12 hours	5 to 10 days
Acute community-acquired pneumonia	400 mg	200 mg Q 12 hours	14 days
Acute bacterial exacerbations of chronic bronchitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)	200 mg	single dose
Skin and skin structure	800 mg	400 mg Q 12 hours	7 to 14 days
Acute maxillary sinusitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated urinary tract infection	200 mg	100 mg Q 12 hours	7 days

GRANULES FOR ORAL SUSPENSION

Adults and Adolescents (age 12 years and older)

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Pharyngitis and/or tonsillitis	200 mg	100 mg Q 12 hours	5 to 10 days
Acute community-acquired pneumonia	400 mg	200 mg Q 12 hours	14 days
Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)	200 mg	single dose
Skin and skin structure	800 mg	400 mg Q 12 hours	7 to 14 days
Acute maxillary sinusitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated urinary tract infection	200 mg	100 mg Q 12 hours	7 days

Infants and Pediatric Patients (age 2 months through 12 years)

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Acute otitis media	10 mg/kg/day (Max 400 mg/day)	5 mg/kg Q 12 h (Max 200 mg/dose)	5 days
Pharyngitis and/or tonsillitis	10 mg/kg/day (Max 200 mg/day)	5 mg/kg/dose Q 12 h (Max 100 mg/dose)	5 to 10 days
Acute maxillary sinusitis	10 mg/kg/day (Max 400 mg/day)	5 mg/kg Q 12 hours (Max 200 mg/dose)	10 days

Patients with Renal Dysfunction

Weight (kg) x (140 - age)

Patients with Cirrhosis

HOW SUPPLIED

Cefpodoxime Proxetil Tablets, USP 100 mg





Cefpodoxime Proxetil Tablets, USP 200 mg





Store at

REFERENCES

 

• NCCLS. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically –fourth edition; Approved standard. NCCLS document M7-A4 (ISBN 1-56238-309-4). NCCLS, 940 West Valley Rd., Suite 1400, Wayne, PA 19087-1898, 1997.
• NCCLS. Performance standards for antimicrobial susceptibility testing; Eighth informational supplement. NCCLS document M100-S8 (ISBN 1-56238-337-x). NCCLS, 940 West Valley Rd., Suite 1400, Wayne, PA 19087-1898, 1998.
• NCCLS. Performance standards for antimicrobial disk susceptibility tests - sixth edition; Approved standard. NCCLS document M2-A6 (ISBN 1-56238-306-6). NCCLS, 940 West Valley Rd., Suite 1400, Wayne, PA 19087-1898, 1997.

CLINICAL TRIALS

Cystitis

Pathogen	Cefpodoxime	Comparator
E. coli	200/243 (82%)	99/123 (80%)
Other pathogens	34/42 (81%)	23/28 (82%)
K. pneumoniae  P. mirabilis  S. saprophyticus
TOTAL	234/285 (82%)	122/151 (81%)

Acute Otitis Media Studies

	Cefpodoxime Proxetil	Cefixime
Pathogen	5 mg/kg Q 12 h x 5 d
S. pneumoniae	88/122 (72%)	72/124 (58%)
H. influenzae	50/76 (66%)	61/81 (75%)
M. catarrhalis	22/39 (56%)	23/41 (56%)
S. pyogenes	20/25 (80%)	13/23 (57%)
Clinical success rate	171/254 (67%)	165/258 (64%)

Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)

Cefpodoxime Proxetil
Tablets, USP 200 mg*
Rx only               100 Tablets
AUROBINDO

CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED Product Information Product Type Human prescription drug label Item Code (Source) NDC:55289-393(NDC:65862-096) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cefpodoxime proxetil cefpodoxime 200 mg Inactive Ingredients Ingredient Name Strength carboxymethylcellulose calcium lactose monohydrate hydroxypropyl cellulose SODIUM LAURYL SULFATE CROSPOVIDONE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) titanium dioxide propylene glycol FD&C YELLOW NO. 6 FD&C RED NO. 40 Product Characteristics Color Size Imprint Code Shape RED (Coral Red) 15 mm C;62 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55289-393-02 2 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065370 2007-06-11