maxaquin- lomefloxacin hydrochloride tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

lomefloxacin hydrochloride (UNII: 9VC7S3ZXXB) (lomefloxacin - UNII:L6BR2WJD8V)

Tilgængelig fra:

G.D. Searle LLC

INN (International Name):

lomefloxacin hydrochloride

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

400 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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).

Produktets egenskaber

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