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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CEFPODOXIME PROXETIL

Composition:

CEFPODOXIME 200 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

Product summary:

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 2 NDC 55289-393-02 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
PD-RX PHARMACEUTICALS, INC.
----------
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
21
27
5
9
2
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.
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 th