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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: PRESCRIBING INFORMATION

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 C17H19F2N3O3 x HCl.

Lomefloxacin Hydrochloride 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, hypromellose, hydroxypropyl cellulose, lactose, polyethylene glycol, magnesium stearate, polyoxyl 40 stearate, and titanium dioxide.


CLINICAL PHARMACOLOGY

Maxaquin clinical pharmacology


PHARMACOKINETICS

Maxaquin pharmacokinetics


PHARMACOKINETICS IN SPECIFIC POPULATIONS

Maxaquin pharmacokinetics in specific populations


MICROBIOLOGY

Maxaquin microbiology


SUSCEPTIBILITY TESTS

Maxaquin susceptibility tests


CLINICAL STUDIES

Maxaquin clinical studies


ANIMAL PHARMACOLOGY

Maxaquin animal pharmacology


INDICATIONS AND USAGE

Maxaquin indications and usage


CONTRAINDICATIONS

Maxaquin (Lomefloxacin HCl) is contraindicated in persons with a history of hypersensitivity to lomefloxacin or any member of the quinolone group of antimicrobial agents.


WARNINGS

Maxaquin warnings


SPECIAL WARNINGS

Maxaquin special warnings


PRECAUTIONS

Maxaquin precautions


DRUG INTERACTIONS

Maxaquin drug interactions


NONCLINICAL TOXICOLOGY

Maxaquin nonclinical toxicology


USE IN SPECIFIC POPULATIONS

Maxaquin use in specific populations


ADVERSE CLINICAL EVENTS

Maxaquin adverse clinical events


ADVERSE REACTIONS

Maxaquin adverse reactions


OVERDOSAGE

Information on overdosage in humans is limited. In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. Hemodialysis or peritoneal dialysis is unlikely to aid in the removal of lomefloxacin as < 3% is removed by these modalities.

Clinical signs of acute toxicity in rodents progressed from salivation to tremors, decreased activity, dyspnea, and clonic convulsions prior to death. These signs were noted in rats and mice as lomefloxacin doses were increased.


DOSAGE AND ADMINISTRATION

Maxaquin dosage and administration


HOW SUPPLIED

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 bottle of 20.

Storage

Store at 59° to 77°F (15° to 25°C).

Manufactured and distributed by Pfizer pharmaceutical company and its divisions.

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