Country: United States
Language: English
Source: NLM (National Library of Medicine)
CEFDITOREN PIVOXIL (UNII: 78THA212DH) (CEFDITOREN - UNII:81QS09V3YW)
Pharma RomLev Inc.
CEFDITOREN PIVOXIL
CEFDITOREN 200 mg
ORAL
PRESCRIPTION DRUG
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: Cefditoren Pivoxil is effective in the eradication of Streptococcus pyoge
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 follows:
New Drug Application
CEFDITOREN PIVOXIL- CEFDITOREN PIVOXIL TABLET, FILM COATED PHARMA ROMLEV INC. ---------- CEFDITOREN PIVOXIL TABLETS 200 MG AND 400 MG Cefditoren Pivoxil Tablets 200 mg and 400 mg To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefditoren Pivoxil tablets and other antibacterial drugs, Cefditoren Pivoxil should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefditoren Pivoxil 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. 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 carnauba wax, hypromellose, 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 hydrolyzed to cefditoren by esterases. Maximal plasma concentrations (C ) of cefditoren under 25 28 6 7 3 max fasting co Read the complete document