Cravit/Cravit IV

Cravit/Cravit IV Description



Daiichi Sankyo


Full Prescribing Info
Each film-coated tablet of CRAVIT 250mg contains 250mg of levofloxacin as active ingredient corresponding to 256.23mg of levofloxacin hemihydrate and each film-coated tablet of CRAVIT 500mg contains 500mg of levofloxacin as active ingredient corresponding to 512.46mg of levofloxacin hemihydrate.
Cravit i.v. 5mg/ml is a sterile clear greenish-yellow solution for intravenous administration. Each 50ml bottle contains 250mg of levofloxacin as active substance. Each 100ml bottle contains 500mg of levofloxacin as active substance.
The solution also contains the following ingredients: sodium chloride; sodium hydroxide; hydrochloric acid (qs: pH 4.8) and water for injection (Na+ concentration: 154mmol/L).
CRAVIT (levofloxacin) Tablets/Injection are synthetic broad spectrum antibacterial agents for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-5-carboxylic acid hemihydrate.
Its empirical formula of C18H20FN3O4·½H2O and its molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2.
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