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
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
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.
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.
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.
SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18
YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN
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
Cases of peripheral neuropathy have been reported in patients receiving flouroquinolones.
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.
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.
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.
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 1-866-290-0698 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.