CEFPODOXIME PROXETIL - cefpodoxime proxetil tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Gen-Source Rx

DCI (Denominação Comum Internacional):

CEFPODOXIME PROXETIL

Composição:

CEFPODOXIME 100 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 cefpodoxim

Resumo do produto:

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 100                                     NDC 52343-019-01 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 100                                     NDC 52343-020-01 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CEFPODOXIME PROXETIL - CEFPODOXIME PROXETIL TABLET, FILM COATED
GEN-SOURCE RX
----------
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 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.
21
27
5
9
2
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 recommended d