CEFPODOXIME PROXETIL- cefpodoxime proxetil_tablet, film coated

Absorption and Excretion in vivo. Effects of Food max Pharmacokinetics of cefpodoxime proxetil film-coated tablets max max max Dose Time after Oral Ingestion (Cefpodoxime Equivalents ) 1hr 2hr 3hr 4hr 6hr 8hr 12hr 100 mg 0.98 1.4 1.3 1 0.59 0.29 0.08 200 mg 1.5 2.2 2.2 1.8 1.2 0.62 0.18 400 mg 2.2 3.7 3.8 3.3 2.3 1.3 0.38 Distribution 90 S. pyogenes 90 S. pneumoniae H. influenzae Effects of Decreased Renal Function PRECAUTIONS DOSAGE AND ADMINISTRATION Effect of Hepatic Impairment (cirrhosis) 1/2 Pharmacokinetics in Elderly Subjects PRECAUTIONS max max Microbiology Gram-positive bacteria Staphylococcus aureus Staphylococcus saprophyticus Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis Haemophilus influenzae Moraxella catarrhalis Neisseria gonorrhoeae Gram-positive bacteria Streptococcus agalactiae Gram-negative bacteria Citrobacterdiversus Klebsiellaoxytoca Proteus vulgaris Providenciarettgeri Haemophilusparainfluenzae Anaerobic Gram-positive bacteria Peptostreptococcusmagnus

Cefpodoxime proxetil 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. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media Streptococcus pneumoniae Streptococcus pyogenes, Haemophilusinfluenzae or Moraxella (Branhamella) catarrhalis Pharyngitis and/or tonsillitis Streptococcus pyogenes NOTE: Community-acquired pneumonia S. pneumoniae or H. Influenzae Acute bacterial exacerbation of chronic bronchitis S. pneumoniae, H. influenzae M. catarrhalis. H. influenzae. Acute, uncomplicated urethral and cervical gonorrhea Neisseria gonorrhoeae Acute, uncomplicated ano-rectal infections in women Neisseria gonorrhoeae NOTE: N. gonorrhoeae N. gonorrhoeae Uncomplicated skin and skin structure infections Staphylococcus aureus Streptococcus pyogenes NOTE: DOSAGE AND ADMINISTRATION Acute maxillary sinusitis Haemophilusinfluenzae Streptococcus pneumoniae Moraxella catarrhalis. Uncomplicated urinary tract infections (cystitis) Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis Staphylococcus saprophyticus NOTE: CLINICAL STUDIES

(See INDICATIONS AND USAGE for indicated pathogens.) See 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 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 Patients with Renal Dysfunction Males: Weight (kg) × (140 - age) (mL/min) 72 × serum creatinine (mg/100 mL) Females: 0.85 × above value (mL/min) Patients with Cirrhosis

Clinical Trials multiple doses Incidence Greater Than 1 % Diarrhea 7 % Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. difficile WARNINGS.) Nausea 3.3 % Vaginal Fungal Infections 1 % Vulvovaginal Infections 1.3 % Abdominal Pain 1.2 % Headache 1 % Incidence Less Than 1 %: By body system in decreasing order Clinical Studies less than 1% Body Respiratory Skin Special Senses Urogenital single dose Nausea 1.4 % Diarrhea 1.2 % Incidence Less Than 1 % Central Nervous System: Dermatologic: Genital: Gastrointestinal: Psychiatric: Laboratory Changes Adverse Reactions and Abnormal Laboratory Tests: DOSAGE AND ADMINISTRATION OVERDOSAGE

Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.

Pregnancy
Teratogenic Effects Pregnancy Category B Cefpodoxime proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m2).
Nursing Mothers
Cefpodoxime is excreted in human milk. In a study of 3 lactating women, levels of cefpodoxime in human milk were 0%, 2% and 6% of concomitant serum levels at 4 hours following a 200 mg oral dose of cefpodoxime proxetil. At 6 hours post-dosing, levels were 0%, 9% and 16% of concomitant serum levels. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and efficacy in infants less than 2 months of age have not been established.
Geriatric Use
Of the 3338 patients in multiple-dose clinical studies of cefpodoxime proxetil film-coated tablets, 521 (16%) were 65 and over, while 214 (6%) were 75 and over. No overall differences in effectiveness or safety were observed between the elderly and younger patients. In healthy geriatric subjects with normal renal function, cefpodoxime half-life in plasma averaged 4.2 hours and urinary recovery averaged 21% after a 400 mg dose was given every 12 hours for 15 days. Other pharmacokinetic parameters were unchanged relative to those observed in healthy younger subjects. Dose adjustment in elderly patients with normal renal function is not necessary.

Drug Interactions
Antacids 2
Drug/Laboratory Test Interactions
Cephalosporins, including cefpodoxime proxetil, are known to occasionally induce a positive direct Coombs’ test.

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. C. difficile. C. difficile C. difficile C. difficile C. difficile C. difficile
Carcinogenesis,Mutagenesis, Impairment of Fertility
Long-term animal carcinogenesis studies of cefpodoxime proxetil have not been performed. Mutagenesis studies of cefpodoxime, including the Ames test both with and without metabolic activation, the chromosome aberration test, the unscheduled DNA synthesis assay, mitotic recombination and gene conversion, the forward gene mutation assay and the in vivo
Labor and Delivery
Cefpodoxime proxetil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
OVERDOSAGE
In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects.
CLINICAL TRIALS
Cystitis Pathogen Cefpodoxime Comparator E. coli 200/243 (82%) 99/123 (80%) Other pathogens K. pneumoniae P. mirabilis 34/42 (81%) 23/28 (82%) TOTAL 234/285 (82%) 122/151 (81%) In these studies, clinical cure rates and bacterial eradication rates for cefpodoxime proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis. Acute Otitis Media Studies Pathogen Cefpodoxime Proxetil Cefixime 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%) Manufactured by: INDIA. Distributed by: PT3652 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Golden State Medical Supply, Inc.

CEFPODOXIME PROXETIL- cefpodoxime proxetil_tablet, film coated Product manual source documgent