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FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION and Clinical Studies.)
Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
*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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
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).
The clinical decision regarding the use of a 5 day or 7 day regimen should be guided by results of the initial sputum culture.
Table 4: Recommended Dosage Regimen of FACTIVE
|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
|Creatinine Clearance (mL/min)||Dose|
|> 40||See Usual Dosage|
|≤ 40||160 mg every 24 hours|
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine Clearance (mL/min) = Weight (kg) x (140 - age) /72 x serum creatinine (mg/dL)
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.
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 NDC 10122-321-05
320 mg Unit of Use (CR*) 7's NDC 10122-321-07
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.
Revised: August 2011. Manufactured for: Cornerstone Therapeutics Inc., Cary, NC 27518. Licensed from LG Life Sciences, Ltd. Seoul, Korea.
Last reviewed on RxList: 10/27/2011
This monograph has been modified to include the generic and brand name in many instances.
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