Generic name: GEMIFLOXACIN MESYLATE 320mg
Dosage form: tablet
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FACTIVE can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of FACTIVE is 320 mg daily, according to the following table (Table 4).
Table 4. Recommended Dosage Regimen of FACTIVE
The clinical decision regarding the use of a 5 or 7 day regimen should be guided by results of the initial sputum culture.
|INDICATION||DOSE / DURATION|
|Acute bacterial exacerbation of chronic bronchitis||One 320 mg tablet daily for 5 days|
|Community-acquired pneumonia (of mild to moderate severity)|
|due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection||One 320 mg tablet daily for 5 days|
|due to known or suspected MDRSP*, K. pneumoniae, or M. catarrhalis infection||One 320 mg tablet daily for 7 days|
*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
The recommended dose and duration of FACTIVE should not be exceeded (see Table 2).
Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance 40 mL/min. Table 5 provides dosage guidelines for use in patients with renal impairment.
Table 5. Recommended Doses for Patients with Renal Impairment
|>40||See Usual Dosage|
|40||160 mg every 24 hours|
Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Creatinine Clearance Formula
Women: 0.85 x the value calculated for men
Use in Hepatically Impaired Patients: 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.
Use in Elderly: No dosage adjustment is recommended.