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Indications
FACTIVE is indicated for the treatment of infections caused by susceptible strains
of the designated microorganisms in the conditions listed below.
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.
Important Safety Information
WARNING: Fluoroquinolones, including FACTIVE, are associated with an increased risk
of tendinitis and tendon rupture in all ages. This risk is further increased in
older patients usually over 60 years of age, in patients taking corticosteroid drugs,
and in patients with kidney, heart or lung transplants.
Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in persons with
myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis.
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Tendon rupture can occur during or after completion of therapy. FACTIVE should be
discontinued if the patient experiences pain, swelling, inflammation, or rupture
of a tendon.
FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin,
fluoroquinolone antibiotic agents, or any of the product components. Serious hypersensitivity
and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone
therapy, including FACTIVE. Hypersensitivity reactions reported in patients receiving
fluoroquinolone therapy have occasionally been fatal. These reactions may include
serious, sometimes fatal skin reactions such as toxic epidermal necrolysis or Stevens-Johnson
Syndrome; effects on the liver, including hepatitis, jaundice, and acute hepatic
necrosis or failure; renal toxicities including interstitial nephritis and/or acute
renal insufficiency or failure; and hematologic effects, including agranulocytosis,
thrombocytopenia, and other hematologic abnormalities. These reactions may occur
following the first dose or multiple doses. FACTIVE should be discontinued immediately
at the first sign of an immediate type I hypersensitivity skin rash or any other
manifestation of hypersensitivity reaction.
THE SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18 YEARS
OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.
Fluoroquinolones may prolong the QT interval in some patients. FACTIVE should be
avoided in patients with a history of prolongation of the QTc interval, patients
with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients
receiving Class IA or Class III antiarrhythmic agents.
Rare cases of peripheral neuropathy 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 should be used with
caution in patients with known or suspected CNS diseases. If CNS reactions occur,
FACTIVE should be discontinued and appropriate measures instituted.
Clostridium difficile associated diarrhea (CDAD) has been reported with
use of nearly all antibiotic agents, including FACTIVE. If diarrhea occurs, evaluate
for CDAD and treat appropriately.
In clinical trials, rash occurred more often with FACTIVE than therapy with comparator
agents (2.7% vs. 0.6%). Increasing incidence of rash was associated with younger
age (especially below 40), female gender, use of hormone replacement therapy, and
longer duration of therapy.
Moderate to severe photosensitivity/phototoxicity reactions can be associated with
the use of quinolones after sun or UV light exposure. Excessive exposure to the
sun or UV light should be avoided.
Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate
(iron), multivitamin preparations containing zinc or other cations, or Videx®
(didanosine) chewable/buffered tablets or the pediatric powder for oral solution
should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should
not be taken within 2 hours of FACTIVE.
In clinical trials, the most common adverse drug reactions (≥2%) with FACTIVE treatment
were diarrhea, rash, nausea, headache, and abdominal pain.
Please click here for
full Prescribing Information and Medication Guide.
Please click
here for Medication Guide only.
To request a FACTIVE package insert, including the Medication Guide, please click here or call 1-888-661-9260 for a shipment.
You are encouraged to report negative side effects of prescription drugs to the
FDA.
Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
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