Gemifloxacin(patient information)

Gemifloxacin mesylate
FACTIVE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

What is the most important information I should know about FACTIVE?

FACTIVE belongs to a class of antibiotics called fluoroquinolones. FACTIVE can cause side effects that may be serious or even cause death. 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.

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 can include:

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

See the section “What are the possible side effects of FACTIVE?” for more information about side effects.

What is FACTIVE?

FACTIVE is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria. It is not known if FACTIVE is safe and works in children under 18 years of age. Children have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking FACTIVE.

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. Antibiotics including FACTIVE do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking FACTIVE.

Who should not take FACTIVE?

Do not take FACTIVE if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in FACTIVE. Ask your healthcare provider if you are not sure. See the list of ingredients in FACTIVE at the end of this Medication Guide.

What should I tell my healthcare provider before taking FACTIVE?

See “What is the most important information I should know about FACTIVE?”

Tell your healthcare provider about all your medical conditions, including if you:

have tendon problems

have central nervous system problems (such as epilepsy)

have nerve problems

have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”

have low blood potassium (hypokalemia) or magnesium (hypomagnesemia)

have a slow heartbeat (bradycardia)

have a history of seizures

have kidney problems. You may need a lower dose of FACTIVE if your kidneys do not work well.

have rheumatoid arthritis (RA) or other history of joint problems

are pregnant or planning to become pregnant. It is not known if FACTIVE will harm your unborn child.

are breast-feeding or planning to breast-feed. It is not known if FACTIVE passes into breast milk. You and your healthcare provider should decide whether you will take FACTIVE or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal and dietary supplements. FACTIVE and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take FACTIVE or other fluoroquinolones may increase your risk of central nervous system effects and seizures. See “What are the possible side effects of FACTIVE?”

a blood thinner (warfarin, Coumadin, Jantoven)

a medicine to control your heart rate or rhythm (antiarrhythmics). See “What are the possible side effects of FACTIVE?”

erythromycin

an anti-psychotic medicine

a tricyclic antidepressant

a water pill (diuretic)

probenecid (Probalan, Col-Probenecid)

a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. See “What is the most important information I should know about FACTIVE?”

Certain medicines may keep FACTIVE from working correctly. Take FACTIVE either 2 hours before or 3 hours after taking these products:

an antacid, multivitamin, or other product that contains magnesium, aluminum, iron, or zinc.

sucralfate (Carafate).

didanosine (Videx®, Videx® EC).

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take FACTIVE?

Take FACTIVE exactly as prescribed by your healthcare provider.

Take FACTIVE at about the same time each day.

FACTIVE can be taken with or without food.

Swallow FACTIVE whole, and drink plenty of fluids with it. Do not chew FACTIVE. Tell your healthcare provider if you are not able to swallow FACTIVE whole. You will need to take a different antibiotic medicine.

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 (see “What is the most important information I should know about FACTIVE?”),

you have a serious allergic reaction (see “What are the possible side effects of FACTIVE?”), or

your healthcare provider 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.

If you miss a dose of FACTIVE, take it as soon as you remember. Do not take more than 1 dose of FACTIVE in one day.

If you take too much, call your healthcare provider or get medical help immediately.

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 provider right away. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of FACTIVE?

FACTIVE can cause side effects that may be serious or even cause death. See “What is the most important information I should know about FACTIVE?”

Other serious side effects of FACTIVE include:

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

fain

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)

See “What should I avoid while taking FACTIVE?”

The most common side effects of FACTIVE include:

diarrhea

rash

nausea

headache

stomach pain

vomiting

dizziness

These are not all the possible side effects of FACTIVE. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FACTIVE?

Store FACTIVE at 59º - 86ºF (15º to 30ºC). Keep FACTIVE away from light.

Keep FACTIVE and all medicines out of the reach of children.

General Information about FACTIVE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FACTIVE for a condition for which it is not prescribed. Do not give FACTIVE to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about FACTIVE. If you would like more information about FACTIVE, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FACTIVE that is written for healthcare professionals. For more information go to www.FACTIVE.com or call 1-866-432-2848.

What are the ingredients in FACTIVE?

Active ingredient: gemifloxacin

Inactive ingredients: crospovidone, hydroxypropyl methycellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Revised October 2008 © Oscient Pharmaceuticals Corporation 2008 FACTIVE is a registered trademark of LG Life Sciences.

Manufactured for: Oscient Pharmaceuticals Waltham, MA 02451-1478 USA

Licensed from LG Life Sciences, Ltd. Seoul, Korea

This Medication Guide has been approved by the U.S. Food and Drug Administration.

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf