CEFPODOXIME PROXETIL granule, for suspension

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 50 mg in 5 mL

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 for Oral Suspension, USP provides the equivalent of 50 mg or 100 mg cefpodoxime per 5 mL suspension (when constituted as directed) and is available as off-white colored granular powder in the following sizes:           50 mg/5 mL          50-mL suspension                          NDC 65862-140-50          75-mL suspension                          NDC 65862-140-75          100-mL suspension                        NDC 65862-140-01                     100 mg/5 mL          50-mL suspension                          NDC 65862-141-50          75-mL suspension                          NDC 65862-141-75          100-mL suspension                        NDC 65862-141-01 Store unsuspended granules 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]. Directions for mixing are included on the label. After mixing, suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFPODOXIME PROXETIL - CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION
AUROBINDO PHARMA LIMITED
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CEFPODOXIME PROXETIL FOR ORAL SUSPENSION, 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 flavoured granules for oral
suspension.
21
27
5
9 2
Each 5 mL of cefpodoxime proxetil for oral suspension USP contains
cefpodoxime
proxetil USP equivalent to 50 mg or 100 mg of cefpodoxime activity
after constitution
and the following inactive ingredients: lactose monohydrate, corn
starch, croscarmellose
sodium, ferric oxide yellow, hydroxypropyl cellulose, microcrystalline
cellulose and
carboxymethyl cellulose sodium, colloidal silicon dioxide, citric acid
anhydrous, sodium
citrate, sodium benzoate, sucrose, and citron & vanille flavorings.
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 recomm