HOW AND WHERE TO BUY GEMIFLOXACIN MESYLATE (FACTIVE) 320 MG TABLETS OR CAPSULES ONLINE:
FACTIVE (GEMIFLOXACIN MESYLATE) TABLETS: SPECIAL WARNINGS
Tendinopathy and Tendon Rupture
Fluoroquinolones, including Gemifloxacin (Factive) tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Factive should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
The safety and effectiveness of factive in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established.
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones.
In clinical studies with Factive, central nervous system (CNS) effects have been reported infrequently. As with other fluoroquinolones, Factive (Gemifloxacin Mesylate) pills should be used with caution in patients with CNS diseases such as epilepsy or patients predisposed to convulsions. Although not seen in Factive clinical trials, convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving other fluoroquinolones. CNS stimulation which may lead to tremors, anxiety, restlessness, lightheadedness, hallucinations, confusion, paranoia, insomnia, depression, and rarely suicidal thoughts or acts may also be caused by other fluoroquinolones. If these reactions occur in patients receiving Gemifloxacin (Factive) pills, the drug should be discontinued and appropriate measures instituted.
Clostridium difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Factive, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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Factive prescribing information