SPECTRACEF- cefditoren pivoxil tablet, film coated SPECTRACEF- cefditoren pivoxil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFDITOREN PIVOXIL (UNII: 78THA212DH) (CEFDITOREN - UNII:81QS09V3YW)

Available from:

Vansen Pharma Inc.

INN (International Name):

CEFDITOREN PIVOXIL

Composition:

CEFDITOREN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SPECTRACEF® (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below. Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains). Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes . NOTE: SPECTRACEF® is effective in the eradication of Streptococcu

Product summary:

SPECTRACEF® (cefditoren pivoxil) tablets containing cefditoren pivoxil equivalent to 200 mg or 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 200” or “CBP 400” in blue. These tablets are available in blister packages, as follow:

Authorization status:

New Drug Application

Summary of Product characteristics

SPECTRACEF- CEFDITOREN PIVOXIL TABLET, FILM COATED
VANSEN PHARMA INC.
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SPECTRACEF® (CEFDITOREN PIVOXIL) TABLETS 200 MG AND 400 MG
Spectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be
used only to treat infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
SPECTRACEF® tablets contain cefditoren pivoxil, a semi-synthetic
cephalosporin antibiotic for oral
administration. It is a prodrug which is hydrolyzed by esterases
during absorption, and the drug is
distributed in the circulating blood as active cefditoren.
Chemically, cefditoren pivoxil is
(-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-
aminothiazol-4-yl)-2-methoxy-iminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula is C
H N O S and the molecular
weight is 620.73. The structural formula of cefditoren pivoxil is
shown below:
CEFDITOREN PIVOXIL
CEFDITOREN PIVOXIL
The amorphous form of cefditoren pivoxil developed for clinical use is
a light yellow powder. It is
freely soluble in dilute hydrochloric acid and soluble at levels equal
to 6.06 mg/mL in ethanol and <0.1
mg/mL in water.
SPECTRACEF® (cefditoren pivoxil) tablets contain 200 mg or 400 mg of
cefditoren as cefditoren
pivoxil and the following inactive ingredients: croscarmellose sodium,
mannitol, magnesium stearate,
sodium caseinate (a milk protein), and sodium tripolyphosphate. The
tablet coating contains
hydroxypropyl cellulose carnauba wax, polyethylene glycol, and
titanium dioxide. Tablets are printed
with ink containing opacode blue S-1-10533.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Absorption
_Oral Bioavailability_
Following oral administration, cefditoren pivoxil is absorbed from the
gastrointestinal tract and
25
28
6
7
3
hydrolyzed to cefditoren by esterases. Maximal plasma concentrations
(C
) of cefditoren