CEFPODOXIME PROXETIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFPODOXIME PROXETIL (UNII: 2TB00A1Z7N) (CEFPODOXIME - UNII:7R4F94TVGY)

Available from:

Aurobindo Pharma Limited

INN (International Name):

CEFPODOXIME PROXETIL

Composition:

CEFPODOXIME 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes , Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains).  Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes . NOTE:  Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of  streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available. Community-acquired pneumonia  caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).  Acute bacterial exacerbation of chronic bronchitis  caused by S. pneumoniae , H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis . Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae .  Acute, uncomplicated urethral and cervical gonorrhea   caused by Neisseria gonorrhoeae (including penicillinase-producing strains).  Acute, uncomplicated ano-rectal infections in women   due to Neisseria gonorrhoeae (including penicillinase-producing strains).  NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.  Uncomplicated skin and skin structure infections  caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes . Abscesses should be surgically drained as clinically indicated.  NOTE:  In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION .)  Acute maxillary sinusitis   caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae , and Moraxella catarrhalis .  Uncomplicated urinary tract infections (cystitis)   caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis , or Staphylococcus saprophyticus .  NOTE:  In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)  Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.  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 is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.

Product summary:

Cefpodoxime Proxetil Tablets, USP 100 mg are light yellowish-orange, elliptical, film-coated tablets debossed with ‘C’ on one side and ‘61’ on the other side.                             Bottles of 20                                       NDC 65862-095-20                             Bottles of 100                                     NDC 65862-095-01                             Bottles of 250                                     NDC 65862-095-25                             Bottles of 1,000                                  NDC 65862-095-99 Cefpodoxime Proxetil Tablets, USP 200 mg are coral red, elliptical, film-coated tablets debossed with ‘C’ on one side and ‘62’ on the other side.                             Bottles of 20                                       NDC 65862-096-20                             Bottles of 100                                     NDC 65862-096-01                             Bottles of 250                                     NDC 65862-096-25                             Bottles of 1,000                                  NDC 65862-096-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Replace cap securely after each opening.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFPODOXIME PROXETIL - CEFPODOXIME PROXETIL TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
CEFPODOXIME PROXETIL TABLETS, USP
RX ONLY
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 bacteria.
FOR ORAL USE ONLY
DESCRIPTION
Cefpodoxime proxetil is an orally administered, extended spectrum,
semi-synthetic
antibiotic of the cephalosporin class. The chemical name is (RS)-
1(isopropoxycarbonyloxy) ethyl
(+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-
{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo
[4.2.0]oct-2-
ene- 2-carboxylate.
Its molecular formula is C
H
N O S and its structural formula is represented
below:
The molecular weight of cefpodoxime proxetil is 557.6.
Cefpodoxime proxetil is a prodrug; its active metabolite is
cefpodoxime. All doses of
cefpodoxime proxetil in this insert are expressed in terms of the
active cefpodoxime
moiety. The drug is supplied as film-coated tablets.
Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP
equivalent to 100
mg or 200 mg of cefpodoxime activity and the following inactive
ingredients: carboxy
methyl cellulose calcium, lactose monohydrate, hydroxy propyl
cellulose, sodium lauryl
21
27
5
9
2
sulfate, crospovidone, corn starch, magnesium stearate, hypromellose,
titanium dioxide,
propylene glycol and FD&C yellow #6 aluminum lake. In addition, the
100 mg film-coated
tablets contain iron oxide yellow and the 200 mg film-coated tablets
contain FD&C red
#40 aluminum lake.
CLINICAL PHARMACOLOGY
ABSORPTION AND EXCRETION:
Cefpodoxime proxetil is a prodrug that is absorbed from the
gastrointestinal tract and
de-esterified to its active metabolite, cefpodoxime. Following oral
administration of 100
mg of cefpodoxime proxetil to fasting subjects, approximately 50% of
the administered
cefpodoxime dose was absorbed systemically. Over the