SIMPLICEF- cefpodoxime proxetil tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
14-09-2022

Wirkstoff:

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

Verfügbar ab:

Zoetis Inc.

INN (Internationale Bezeichnung):

CEFPODOXIME PROXETIL

Zusammensetzung:

CEFPODOXIME 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION

Anwendungsgebiete:

Cefpodoxime proxetil is contraindicated in dogs with known allergy to cefpodoxime or to the β-lactam (penicillins and cephalosporins) group of antibiotics.

Produktbesonderheiten:

SIMPLICEF tablets are available in the following strengths (cefpodoxime equivalent), colors, and sizes: 100 mg (reddish-orange, elliptical, scored, debossed with 5228) Bottles of 100 Bottles of 250 200 mg (light orange, round rectangle, scored, debossed with 5229) Bottles of 100 Bottles of 250

Berechtigungsstatus:

New Animal Drug Application

Fachinformation

                                SIMPLICEF- CEFPODOXIME PROXETIL TABLET
ZOETIS INC.
----------
SIMPLICEF
SIMPLICEF
(cefpodoxime proxetil tablets)
For Oral Use In Dogs Only
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Cefpodoxime proxetil is an orally administered, extended spectrum,
semi-synthetic
cephalosporin antibiotic. The chemical name is:
(+/-)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-
amino-4-thiazolyl)
glyoxylamido]-3-methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-
2-ene-2-carboxylate, 72-(Z)-(Omethyloxime), isopropyl carbonate
(ester) [87239-81-4].
CEFPODOXIME PROXETIL CHEMICAL STRUCTURE:
Cefpodoxime proxetil is a prodrug; its active metabolite is
cefpodoxime. All doses of
SIMPLICEF (cefpodoxime proxetil) tablets are expressed in terms of the
active
cefpodoxime moiety. SIMPLICEF is available as:
100 MG TABLET, each reddish-orange, elliptical, scored tablet contains
cefpodoxime
proxetil equivalent to 100 mg of cefpodoxime.
200 MG TABLET, each light orange, round rectangle, scored tablet
contains
cefpodoxime proxetil equivalent to 200 mg of cefpodoxime.
INDICATION
SIMPLICEF tablets are indicated for the treatment of skin infections
(wounds and
abscesses) in dogs caused by susceptible strains of _Staphylococcus
intermedius,_
®
®
_Staphylococcus aureus, Streptococcus canis_ (group G, β hemolytic),
_Escherichia coli,_
_Pasteurella multocida,_ and _Proteus mirabilis._
DOSAGE AND ADMINISTRATION
DOSE RANGE
The dose range of SIMPLICEF (cefpodoxime proxetil) tablets is 5-10
mg/kg (2.3-4.5
mg/lb) body weight, administered orally, once a day. The dose may be
given with or
without food. The determination of dosage for any particular patient
must take into
consideration such factors as the severity and nature of the
infection, the susceptibility
of the causative organisms, and the integrity of the patient's
host-defense mechanisms.
Obtain a sample of the pathogenic organism for culture and sensitivity
testing prior to
beginning antimicrobial therapy. Once results become available,
con
                                
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