MAXAQUIN F. C. Tablets Ref.[8876] Active ingredients: Lomefloxacin

Source: European Medicines Agency (EU)  Revision Year: 2005  Publisher: Pfizer Inc. - G.D. Searle LLC

Product name and form

Maxaquin – Lomefloxacin hydrochloride tablets.

Pharmaceutical Form

Film-coated tablets.

Qualitative and quantitative composition

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%.

Active Ingredient Description
Lomefloxacin

Lomefloxacin is a synthetic broad-spectrum antimicrobial agent for oral administration. Lomefloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

List of Excipients

The inactive ingredients are carboxymethylcellulose calcium, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyoxyl 40 stearate, and titanium dioxide.

Pack sizes and marketing

Maxaquin (lomefloxacin HCl) is supplied as a scored, filmcoated 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:

NDC NumberSize
0025-5501-01bottle of 20

Store at 59° to 77°F (15° to 25°C).

Marketing authorization holder

Pfizer Inc. - G.D. Searle LLC

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