SPECTRACEF Film-coated tablet Ref.[10834] Active ingredients: Cefditoren

Source: FDA, National Drug Code (US)  Revision Year: 2013 

Product 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 C25H28N6O7S3 and the molecular weight is 620.73.

The structural formula of cefditoren pivoxil is shown below:

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.

How Supplied

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:

  • NDC 44004-802-20: 400 mg 20 count blister pack. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.
  • NDC 44004-802-28: 400 mg 28 count blister pack. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.
  • NDC 44004-802-02: 400 mg 2 count blister. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 400 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 400” in blue.
  • NDC 44004-801-20: 200 mg 20 count blister pack. SPECTRACEF tablets containing cefditoren pivoxil equivalent to 200 mg of cefditoren are available as white, elliptical, film-coated tablets imprinted with “CBP 200” in blue.

Manufactured by: Tedec-Meiji Farma, S.A, Madrid, Spain

Distributed by: Vansen Pharma Inc., Westmount, QC H3Z 3C1

Drugs

Drug Countries
SPECTRACEF Ecuador, Spain, Israel, Mexico, Turkey
 
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