HOW AND WHERE TO BUY GEMIFLOXACIN MESYLATE (FACTIVE) 320 MG TABLETS OR CAPSULES ONLINE:
FACTIVE (GEMIFLOXACIN MESYLATE) TABLETS: USE IN SPECIFIC POPULATIONS
Pregnancy Category C
Gemifloxacin Mesylate (Factive) treatment during organogenesis caused fetal growth retardation in mice (oral dosing at 450 mg/kg/day), rats (oral dosing at 600 mg/kg/day) and rabbits (IV dosing at 40 mg/kg/day) at AUC levels which were 2-, 4- and 3-fold those in women given oral doses of 320 mg. In rats, this growth retardation appeared to be reversible in a pre- and postnatal development study (mice and rabbits were not studied for the reversibility of this effect). Treatment of pregnant rats at 8-fold clinical exposure (based upon AUC comparisons) caused fetal brain and ocular malformations in the presence of maternal toxicity. The overall no-effect exposure level in pregnant animals was approximately 0.8 to 3-fold clinical exposure.
The safety of Factive in pregnant women has not been established. This medication should not be used in pregnant women unless the potential benefit to the mother outweighs the risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Gemifloxacin is excreted in the breast milk of rats. There is no information on excretion of gemifloxacin into human milk. Therefore, Factive (Gemifloxacin) tablets should not be used in lactating women unless the potential benefit to the mother outweighs the risk.
Safety and effectiveness in children and adolescents less than 18 years of age have not been established. Fluoroquinolones, including gemifloxacin, cause arthropathy and osteochondrosis in immature animals.
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Gemifloxacin (Factive) tablets. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Factive to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Factive (Gemifloxacin Mesylate) tablets and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.
Of the total number of subjects in clinical studies of Factive, 29% (2314) were 65 and over, while 11% (865) were 75 and over. No overall difference in effectiveness was observed between these subjects and younger subjects; the adverse event rate for this group was similar to or lower than that for younger subjects with the exception that the incidence of rash was lower in geriatric patients compared to patients less than 40 years of age.
Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, Gemifloxacin Mesylate (Factive) tablets should be avoided in patients taking drugs that can result in prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmics) or in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).
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Factive prescribing information