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:

Sandoz Inc

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 pr

Product summary:

Cefpodoxime Proxetil Tablets, USP are available in the following strengths (cefpodoxime equivalent), colors, and sizes: 100 mg, (light orange, film-coated, elliptical, embossed with SZ 438) Bottles of 20 NDC 0781-5438-20 Bottles of 100 NDC 0781-5438-01 200 mg, (light orange, film-coated, oblong, embossed with SZ 439) Bottles of 20 NDC 0781-5439-20 Bottles of 100 NDC 0781-5439-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening. KEEP OUT OF THE REACH OF CHILDREN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFPODOXIME PROXETIL- CEFPODOXIME PROXETIL TABLET, FILM COATED
SANDOZ INC
----------
CEFPODOXIME PROXETIL TABLETS, USP
FOR ORAL USE ONLY
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
cefpodoxime proxetil tablets and other antibacterial drugs,
cefpodoxime proxetil tablets
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
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 structural formula is represented below:
MOLECULAR FORMULA: C
H N O S
MOLECULAR WEIGHT: 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
equivalent to 100 mg or
200 mg of cefpodoxime activity. Each film-coated tablet contains the
following inactive
ingredients: carboxymethylcellulose calcium, crospovidone, FD&C Yellow
No. 6,
hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium
stearate,
sodium lauryl sulfate, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
21
27
5
9 2
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
dosing range
(100 to 400 mg), approximately 29 to 33% of the administered
cefpodoxime dose was
excreted unchanged in the urine in 12 hours. There is minimal
metabolism of
cefpodoxime