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Home >> Patients > Role of FACTIVE > What dose FACTIVE do

What dose FACTIVE do

How do antibiotics work?

Bacterial infections are among the most common reasons that people seek health care worldwide. These infections interfere with activities of daily living, burden the health care system, and can lead to serious medical complications.

Different antibiotics work in different ways to kill bacteria. Fluoroquinolone antibiotics are "bactericidal," which means they kill the bacteria causing the infection. Some other types of antibiotics stop bacteria from growing. Fluoroquinolones are concentration-dependent drugs, meaning they kill bacteria more efficiently when a higher amount of medicine reaches the area of infection. Your healthcare professional will prescribe the best antibiotic strength and duration for your infection.

What are fluoroquinolones?

Fluoroquinolones are a type of antibiotic used to treat bacterial infections. They are usually given orally (as tablets), but can be given intravenously in the hospital for serious infections.
Because they are "bactericidal," fluoroquinolones actually kill the bacteria that are causing an infection. Fluoroquinolones work by preventing bacteria from reproducing.

How do fluoroquinolones work?

In order for bacteria to multiply, DNA strands within their cells must split apart and then reattach themselves. It is believed that fluoroquinolones work by interrupting this process. The DNA strands cannot reattach and, as a result, the cell dies.

What is antibiotic resistance?

While antibiotics are an effective way to treat bacterial infections, improper use can lead to antibiotic resistance. Resistance happens because bacteria can change, or "mutate," in ways that makes it harder for antibiotics to work against them.

What you can do

One of the ways you can help guard against antibiotic resistance is to remember the 3 Ds of appropriate antibiotic use:

  • Drug. Use only the antibiotic that your healthcare professional prescribed for your condition. Do not use an antibiotic prescribed for another person or for another illness, and never share your antibiotics with someone else
  • Dose. Take the correct amount of your drug at the correct times, as prescribed by your healthcare professional
  • Duration. Even if you start to feel better, continue taking your antibiotic exactly as prescribed to help ensure that no bacteria can survive

What does FACTIVE do?

Many strains of bacteria have developed resistance to the older antibiotics. Drug-resistant bacteria are becoming increasingly common.

FACTIVE is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain bacteria. FACTIVE is highly active against many kinds of bacteria, including those that are most likely to contribute to sinusitis, bronchitis and pneumonia: Haemophilus influenzae, Mycoplasma pneumoniae and Streptococcus pneumoniae, including Streptococcus pneumoniae bacteria that are resistant to common, older antibiotics like amoxicillin and clarithromycin.

The growing prevalence of multi-drug resistant Streptococcus pneumoniae (MDRSP) illustrates the need for powerful, broad spectrum antibiotic therapy. Factive is the first antibiotic FDA-approved to treat MDRSP and is the most potent quinolone against S pneumoniae in vitro*. Factive is indicated for a broad spectrum of common respiratory pathogens in mild to moderate community-acquired pneumonia and acute execration of chronic bronchitis. By selecting Factive, physicians gain confidence through coverage of both susceptible§ and resistant strains of indicated pathogens.

*In vitro is performed not in a living organism but in a controlled environment, such as in a test tube or Petri dish.

§ Susceptible is accessible or especially liable or subject to some influence, mood, agency, etc.

References

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Important Safety Information

THE SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

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.

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. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking FACTIVE until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

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 (2.8% 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%) were diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness.

This product is available by prescription only.

* Videx® is a registered trademark of Bristol-Myers Squibb Company.

For US residents,
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.

For Non-US residents,
You are encouraged to report negative side effects of prescription drugs, please click here or call 82-2-6924-3620.

Please note that the information contained on this site is intended for international health care providers and may not be appropriate for your country of origin. Please see the full FACTIVE prescribing information for your country for approved product indications, dosing, and important safety considerations. Click on the "Global Countries" tab above to learn how to obtain country-specific prescribing information.

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