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Cheap qualitative Gemifloxacin Mesylate 320 mg tablets online



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FACTIVE (GEMIFLOXACIN MESYLATE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Factive (Gemifloxacin Mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid.

The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Gemifloxacin is considered freely soluble at neutral pH (350 mcg/mL at 37°C, pH 7.0). Its empirical formula is C18H20FN5O4·CH4O3S.

Each white to off-white, oval, film-coated Factive tablet has breaklines and GE 320 debossed on both faces and contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. The inactive ingredients are hydroxypropyl methylcellulose, crospovidone, magnesium stearate, polyethylene glycol, microcrystalline cellulose, povidone, and titanium dioxide.


CLINICAL PHARMACOLOGY

Factive clinical pharmacology


PHARMACOKINETICS IN SPECIAL POPULATIONS

Factive pharmacokinetics in special populations


DRUG-DRUG INTERACTIONS

Factive drug-drug interactions


MICROBIOLOGY

Factive microbiology


SUSCEPTIBILITY TESTS

Factive susceptibility tests


ANIMAL PHARMACOLOGY

Factive animal pharmacology


CLINICAL STUDIES

Factive clinical studies


INDICATIONS AND USAGE

Factive indications and usage


CONTRAINDICATIONS

Factive (Gemifloxacin) tablets are contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components.


WARNINGS

Factive warnings


SPECIAL WARNINGS

Factive special warnings


PRECAUTIONS

Factive precautions


DRUG INTERACTIONS

Factive drug interactions


NONCLINICAL TOXICOLOGY

Factive nonclinical toxicology


USE IN SPECIFIC POPULATIONS

Factive use in specific populations


ADVERSE REACTIONS

Factive adverse reactions


OVERDOSAGE

Any signs or symptoms of overdosage by Gemifloxacin (Factive) should be treated symptomatically. No specific antidote is known. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed and treated symptomatically with appropriate hydration maintained. Hemodialysis removes approximately 20 to 30% of an oral dose of gemifloxacin from plasma.

Mortality occurred at oral gemifloxacin doses of 1600 mg/kg in rats and 320 mg/kg in mice. The minimum lethal intravenous doses in these species were 160 and 80 mg/kg, respectively. Toxic signs after administration of a single high oral dose (400 mg/kg) of gemifloxacin to rodents included ataxia, lethargy, piloerection, tremor, and clonic convulsions.


DOSAGE AND ADMINISTRATION

Factive dosage and administration


HOW SUPPLIED

Factive (Gemifloxacin Mesylate) is available as white to off-white, oval, film-coated tablets with breaklines and GE 320 debossed on both faces. Each tablet contains gemifloxacin mesylate equivalent to 320 mg of gemifloxacin.

320 mg Unit of Use (CR*) 5's
320 mg Unit of Use (CR*) 7's

Child Resistant

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

Manufactured and distributed by LG Life Sciences, Oscient Pharmaceuticals companies, and their divisions.

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