General Precautions for Use
It is recommended that susceptibility of bacteria to FACTIVE should be tested prior to use and FACTIVE should be administered for minimum duration required for effective treatment in order to avoid development of resistance to FACTIVE.
Adequate hydration should be maintained to prevent the formation of highly concentrated urine.
Photosensitivity reaction has been rarely reported with the use of FACTIVE. Patients taking FACTIVE should be avoided unnecessary exposure to strong sunlight or artificial UV rays eg., Sunlamps, solarium, to prevent photosensitivity reaction. FACTIVE should be discontinued if photosensitivity reaction e.g., skin eruption, is suspected.
CNS side effects have been reported rarely in clinical trials with FACTIVE. However, as with other drugs, patients should be observed for reaction to FACTIVE and, if affected, should not drive or operate machinery.
Special Warnings and Precautions for Use
Quinolones may prolong the QTc internal in some patients. FACTIVE should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolytic disorders (hypokalemia or hypomagnesemia), and patients receiving Class ⅠA (e.g., quinidine, procinamide) or Class Ⅲ (e.g., amiodarone, sotalol) antiarrhythmic agents.
FACTIVE should be used with caution in patients with epilepsy or patients with a history of convulsions (risk of convulsion) and Patients with severe renal impairment
FACTIVE should be used with caution in patients with existing or family history of glucose-6-phosphate dehydrogenase deficiency (rarely hemolytic reactions may be developed during therapy)
Special Populations
Elderly
No dosage adjustment is required in the elderly.
Children
Safety and effectiveness in children and adolescents less than 18 years of age have not been established.
Hepatic impairment
No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Renal impairment
In the pharmacokinetic studies, FACTIVE Cmax was not significantly altered in subjects with renal insufficiency.
Creatinine clearance (mL/min) | Dose |
---|---|
>40 | Usual dosage (320mg every 24 hours) |
≤40 | 160mg every 24 hours |
Contraindications
FACTIVE is contraindicated in patients with a history of hypersensitivity to FACTIVE, fluoroquinolone antibiotic agents, or any of the product components.