국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
lomefloxacin hydrochloride (UNII: 9VC7S3ZXXB) (lomefloxacin - UNII:L6BR2WJD8V)
G.D. Searle LLC
lomefloxacin hydrochloride
TABLET, FILM COATED
400 mg
ORAL
PRESCRIPTION DRUG
Maxaquin (lomefloxacin HCl) film-coated tablets are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: (See Dosage and Administration for specific dosing recommendations.) Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae or Moraxella catarrhalis. 1 NOTE: MAXAQUIN IS NOT INDICATED FOR THE EMPIRIC TREATMENT OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS WHEN IT IS PROBABLE THAT S PNEUMONIAE IS A CAUSATIVE PATHOGEN. S PNEUMONIAE EXHIBITS IN VITRO RESISTANCE TO LOMEFLOXACIN, AND THE SAFETY AND EFFICACY OF LOMEFLOXACIN IN THE TREATMENT OF PATIENTS WITH ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS CAUSED BY S PNEUMONIAE HAVE NOT BEEN DEMONSTRATED. IF LOMEFLOXACIN IS TO BE PRESCRIBED FOR GRAM–STAIN–GUIDED EMPIRIC THERAPY OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS, IT SHOULD BE USED ONLY IF SPUTUM GRAM STAIN DEMONSTRATES AN ADEQUATE QUALIT
Maxaquin (lomefloxacin HCl) is supplied as a scored, film-coated tablet containing the equivalent of 400 mg of lomefloxacin base present as the hydrochloride. The tablet is oval, white, and film-coated with "MAXAQUIN 400" debossed on one side and scored on the other side and is supplied in: Store at 59° to 77°F (15° to 25°C).
MAXAQUIN- LOMEFLOXACIN HYDROCHLORIDE TABLET, FILM COATED G.D. SEARLE LLC ---------- MAXAQUIN LOMEFLOXACIN HYDROCHLORIDE TABLETS To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxaquin and other antibacterial drugs, Maxaquin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Maxaquin (lomefloxacin HCl) is a synthetic broad-spectrum antimicrobial agent for oral administration. Lomefloxacin HCl, a difluoroquinolone, is the monohydrochloride salt of (±)-1-ethyl-6,8-difluoro-1,4- dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid. Its empirical formula is C H F N O •HCl, and its structural formula is: Lomefloxacin HCl is a white to pale yellow powder with a molecular weight of 387.8. It is slightly soluble in water and practically insoluble in alcohol. Lomefloxacin HCl is stable to heat and moisture but is sensitive to light in dilute aqueous solution. Maxaquin is available as a film-coated tablet formulation containing 400 mg of lomefloxacin base, present as the hydrochloride salt. The base content of the hydrochloride salt is 90.6%. The inactive ingredients are carboxymethylcellulose calcium, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyoxyl 40 stearate, and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACOKINETICS IN HEALTHY VOLUNTEERS In 6 fasting healthy male volunteers, approximately 95% to 98% of a single oral dose of lomefloxacin was absorbed. Absorption was rapid following single doses of 200 and 400 mg (T 0.8 to 1.4 hours). Mean plasma concentration increased proportionally between 100 and 400 mg as shown below: DOSE (MG) MEAN PEAK PLASMA CONCENTRATION (ΜG/ML) AREA UNDER CURVE (AUC) (ΜG·H/ML) 100 0.8 5.6 200 1.4 10.9 400 3.2 26.1 In 6 healthy male volunteers administered 400 mg of lomefloxacin on an empty stomach qd for 7 days, ® 17 19 2 3 3 max the following mean pharmacokinetic parameter values were obtained: C 2.8 µg/mL 전체 문서 읽기