MAXAQUIN F. C. Tablets (2005)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Maxaquin Lomefloxacin hydrochloride 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%.

Pharmaceutical form

Film-coated tablets.

Therapeutic indications

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 ...

Posology and method of administration

Maxaquin (lomefloxacin HCl) may be taken without regard to meals. Sucralfate and antacids containing magnesium or aluminum, or Videx (didanosine), chewable/buffered tablets or the pediatric powder for ...

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.

Special warnings and precautions for use

Warnings MODERATE TO SEVERE PHOTOTOXIC REACTIONS HAVE OCCURRED IN PATIENTS EXPOSED TO DIRECT OR INDIRECT SUNLIGHT OR TO ARTIFICIAL ULTRAVIOLET LIGHT (eg, sunlamps) DURING OR FOLLOWING TREATMENT WITH LOMEFLOXACIN. ...

Interaction with other medicinal products and other forms of interaction

Drug interactions Theophylline: In three pharmacokinetic studies including 46 normal, healthy Maxaquin lomefloxacin hydrochloride tablets subjects, theophylline clearance and concentration were not significantly ...

Pregnancy and lactation

Pregnancy Teratogenic effects. Pregnancy Category C. Reproductive function studies have been performed in rats at doses up to 8 times the recommended human dose based on mg/m² (34 times the recommended ...

Undesirable effects

In clinical trials, most of the adverse events reported were mild to moderate in severity and transient in nature. During these clinical investigations, 5,623 patients received Maxaquin. In 2.2% of the ...

Overdose

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 ...

Pharmacodynamic properties

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, ...

Pharmacokinetic properties

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 ...

Preclinical safety data

Carcinogenesis, mutagenesis, impairment of fertility Carcinogenesis Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 52 weeks while concurrently being ...

List of excipients

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

Nature and contents of container

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 ...

Marketing authorization holder

Pfizer Inc. - G.D. Searle LLC

Date of revision of the text

January 2005

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