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Common Questions

WHAT IS FACTIVE?

FACTIVE is a broad-spectrum fluoroquinolone antibiotic medicine used in adults to treat pneumonia, bronchitis, sinusitis, otitis, and urinary tract infections caused by certain germs called bacteria. FACTIVE kills many of the types of bacteria that can infect the lungs, sinuses, otitis, and urinary tract. In a large number of clinical trials, FACTIVE has been shown to be a safe and effective way to treat certain bacterial infections. FACTIVE may not be right for everyone. There are some risks. Only your healthcare professional can decide what antibiotic medication is best for you.

WHAT DOES FACTIVE DO?

Clinical studies have shown that FACTIVE is a safe, effective way to treat certain bacterial infections (including sinusitis, bronchitis, and pneumonia). 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.

Factive is indicated for a broad spectrum of common respiratory pathogens in mild to moderate community-acquired pneumonia and acute exacerbation of chronic bronchitis. By selecting Factive, physicians gain confidence through coverage of both susceptible and resistant strains of indicated pathogens.

If you think you may have a bacterial infection, talk with your healthcare professional and find out if FACTIVE may be right for you.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT FACTIVE?

FACTIVE is not for everyone; only your healthcare professional can decide if FACTIVE is right for you. FACTIVE can cause side effects that may be serious or even cause of death.

FACTIVE belongs in a class of antibiotics called fluoroquinolones. Other fluoroquinolones are Cipro® (ciprofloxacin), Avelox® (moxifloxacin), Levaquin® (levofloxacin), ofloxacin, and norfloxacin.

Most people who take FACTIVE do not have major side effects. The most common side effects, which are usually mild, include rash, diarrhea, nausea, headache, abdominal pain, vomiting and dizziness.

If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take FACTIVE.

  • The most common side effects of FACTIVE

  • Diarrhea
  • Rash
  • Nausea
  • Headache
  • Stomach pain
  • Vomiting
  • Dizziness
  • Tendon rupture or swelling of the tendon (tendinitis)

  • Tendons are tough cords of tissue that connect muscles to bones.
  • Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including FACTIVE. The risk of getting tendon problems is higher if you :
  • Are over 60 years of age
  • Are taking steroids (corticosteroids)
  • Have had a kidney, heart or lung transplant.

  • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
  • Other reasons for tendon ruptures
  • Physical activity or exercise
  • Kidney failure
  • Tendon problems in the past, such as in people with rheumatoid arthritis (RA).

  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking FACTIVE until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of FACTIVE. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking FACTIVE. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture :
  • Hear or feel a snap or pop in a tendon area
  • Bruising right after an injury in a tendon area
  • Unable to move the affected area or bear weight
  • Central Nervous System Effects.

Seizures have been reported in people who take fluoroquinolone antibiotics, including FACTIVE. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking FACTIVE will change your risk of having a seizure. Central Nervous System (CNS) side effects may occur as soon as after taking the first dose of FACTIVE.

Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or
behavior :

  • Feel lightheaded
  • Seizures
  • Hear voices, see things, or sense things that are not there (hallucinations)
  • Feel restless
  • Tremors
  • Feel anxious or nervous
  • Confusion
  • Depression
  • Trouble sleeping
  • Feel more suspicious (paranoia)
  • Suicidal thoughts or acts
  • Nightmares
  • Serious allergic reactions.

Allergic reactions can happen in people taking fluoroquinolones, including FACTIVE, even after only one dose.

Stop taking FACTIVE and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

  • Hives
  • Trouble breathing or swallowing
  • Swelling of the lips, tongue, face
  • Throat tightness, hoarseness
  • Rapid heartbeat
  • Faint
  • Yellowing of the skin or eyes. Stop taking FACTIVE and call your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to FACTIVE (a liver problem).
  • Skin rash.

Skin rash may happen in people taking FACTIVE. Stop taking FACTIVE at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to FACTIVE.

Rash happens more often with FACTIVE in :

  • Women, especially women who take hormone replacement therapy
  • People under 40 years of age
  • People who take FACTIVE for longer than 5 days.
  • Serious heart rhythm changes (QTc prolongation and torsades de pointes).

Tell your healthcare provider right away if you have a change in your heartbeat (get a fast or irregular heartbeat), or if you faint. FACTIVE may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous.

The chances of this happening are higher in people :

  • Who are elderly
  • With a family history of prolonged QT interval
  • With low blood potassium (hypokalemia)
  • Who take certain medicines to control heart rhythm (antiarrhythmics).
  • Intestine infection (Pseudomembranous colitis).

Pseudomembranous colitis can happen with most antibiotics, including FACTIVE. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

  • Changes in sensation and possible nerve damage (Peripheral Neuropathy).

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including FACTIVE.

Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

  • Pain
  • Burning
  • Tingling
  • Numbness
  • Weakness

FACTIVE may need to be stopped to prevent permanent nerve damage.

  • Sensitivity to sunlight (photosensitivity)

Avoid sunlamps, tanning beds, and try to limit your time in the sun. FACTIVE can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking FACTIVE, call your healthcare provider right away. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

HOW DOES FACTIVE WORK?

Different antibiotics work in different ways to kill bacteria. FACTIVE is a type of antibiotic called a fluoroquinolone. Fluoroquinolone antibiotics are "bactericidal," which means they kill the bacteria causing the infection. 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.

FACTIVE displays strong binding affinity at dual target sites of action, which helps maintain high in vitro potency even against resistant respiratory bacteria. FACTIVE works differently from most other antibiotics, it is often effective against pathogens that are resistant to other drugs. To kill bacteria, an antibiotic must reach the place where the bacteria are causing trouble - the infected tissues. FACTIVE rapidly penetrates and concentrates in the respiratory tissues. This means it works fast to provide high levels of antibacterial activity right where the infection is.

Your healthcare professional will prescribe the best antibiotic strength and duration for your infection.

WHAT ARE ANTIBIOTICS?

Antibiotics—also known as antibacterial or antimicrobial drugs—fight bacterial infections by killing bacteria, or by slowing or stopping bacterial growth. While antibiotics were first used in the 1940's, they continue to transform medical care today by dramatically reducing illness and death from infectious diseases.

WHAT ARE BACTERIA?

There are many types of bacteria, which are tiny living organisms. Most are harmless and some are even helpful. But some bacteria can cause diseases in humans. Antibiotics fight bacterial infections by slowing or stopping the growth of bacteria.

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 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.

WHAT ARE THE COMMON TYPES OF BACTERIAL RESPIRATORY TRACT INFECTIONS?

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Only your healthcare professional can tell if your infection is viral or bacterial. Antibiotics, including FACTIVE, do not kill viruses.

WHAT ARE THE COMMON TYPES OF BACTERIAL GENITOURINARY (GU) INFECTIONS?

Only your healthcare professional can tell for sure if you have a GU infection. But common symptoms include

  • Frequent urge to urinate
  • Painful, burning feeling in the urethra or bladder, especially when urinating
  • A feeling of fullness or pressure around the pubic bone or, in men, the rectum
  • Feeling an urge to urinate but passing only a small amount of urine

WHAT ARE THE COMMON TYPES OF OTITS INFECTIONS?

Swimmer's ear is also known as acute external otitis or otitis externa. The most common cause of this infection is bacteria invading the skin inside your ear canal. An ear infection (acute otitis media) is most often a bacterial or viral infection that affects the middle ear, the air-filled space behind the eardrum that contains the tiny vibrating bones of the ear.

Only your healthcare professional can tell for sure if you have otitis media infection. Ear infections usually start with a viral infection, such as a cold. The middle ear lining becomes swollen from the infection, and fluid builds up behind the eardrum. Ear infections can also be associated with blockage or swelling in the narrow passageways that connect the middle ear to the nose. When fluid gets trapped in the middle ear when the eustachian tubes (one of a structure in your ear) become blocked during a cold, it can cause ear pain and infection.

WHAT IS THE DIFFERENCE BETWEEN A VIRAL AND A BACTERIAL INFECTION?

There are 2 types of germs that cause most infections: viruses and bacteria. And while the symptoms are often similar, it is important to know that antibiotics only work for infections caused by bacteria. If you have a viral infection, taking an antibiotic will not help and can even be harmful by contributing to antibiotic resistance. How do you know whether your infection is viral or bacterial? Only your healthcare professional can determine if you have a viral or bacterial infection.

HOW SHOULD I TAKE FACTIVE?

FACTIVE should be taken once per day, ideally at the same time each day. Do not take more than the prescribed dose of FACTIVE even if you missed a dose by mistake—you should not take a double dose. Your healthcare professional will determine the number of days you should take FACTIVE.

I MISSED MY DOSE YESTERDAY—CAN I TAKE A DOUBLE DOSE OF FACTIVE TODAY?

Never take more than the prescribed dose of FACTIVE, even if you missed a dose by mistake. You should not take more than one dose in one day. FACTIVE should be taken once per day, ideally at the same time each day.

IF I FEEL BETTER, DO I NEED TO CONTINUE TAKING FACTIVE?

Do not skip any doses, or stop taking FACTIVE, even if you begin to feel better, until you finish your prescribed treatment, unless :

  • You have tendon effects
  • You have a serious allergic reaction
  • Your healthcare professional tells you to stop

This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to FACTIVE. If this happens, FACTIVE and other antibiotic medicines may not work in the future.

DO I NEED TO TAKE FACTIVE WITH FOOD?

FACTIVE should be taken exactly as prescribed by your healthcare professional. Tablets should be swallowed and may be taken with or without food. Try to take the dose at the same time each day and drink fluids liberally.

CAN I TAKE FACTIVE WITH OTHER MEDICINES?

If you are taking steroids (such as corticosteroids for asthma or COPD), it may increase your risk of getting tendon problems when taking FACTIVE. Be sure to discuss this with your healthcare professional.

Taking warfarin (Coumadin®) and FACTIVE together can increase the risk of bleeding problems. If you take warfarin, be sure to tell your healthcare professional.

Many antacids and multivitamins may prevent FACTIVE from working properly. You should take FACTIVE either 2 hours before or 2 hours after taking these products.

It is important to let your healthcare professional know all of the medicines you are using.

WHAT SHOULD I AVOID WHILE TAKING FACTIVE?

  • FACTIVE can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how FACTIVE affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. FACTIVE can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters, or swelling of your skin. If you get any of these symptoms while taking FACTIVE, call your healthcare professional right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

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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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