(gem ah flox' a sin)
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
See the FDA Drug Safety Communication (see http://1.usa.gov/1TdvrCk ) for a list of currently available FDA approved fluoroquinolones for systemic use.
BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee (see http://1.usa.gov/1TaaUBN ) meeting in November 2015.
RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a "pins and needles" tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.
Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient's treatment course.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .
Taking gemifloxacin increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred). If you experience any of the following symptoms of tendinitis, stop taking gemifloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking gemifloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move or to bear weight on an affected area.
Taking gemifloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take gemifloxacin. If you have myasthenia gravis and your doctor tells you that you should take gemifloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking gemifloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with gemifloxacin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Gemifloxacin is used to treat certain infections such as pneumonia or bronchitis. Gemifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics do not work for colds, flu, or other viral infections.
HOW should this medicine be used?
Gemifloxacin comes as a tablet to take by mouth. It is usually taken with or without food once a day for 5 or 7 days. The length of your treatment depends on the type of infection you have. Your doctor will tell you how long to take gemifloxacin. Take gemifloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take gemifloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole with plenty of water; do not split, chew, or crush them.
You should begin feeling better during the first few days of treatment with gemifloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take gemifloxacin until you finish the prescription, even if you feel better. Do not stop taking gemifloxacin without talking to your doctor unless you experience certain serious side effects that are listed in the IMPORTANT WARNING and SIDE EFFECTS sections. If you stop taking gemifloxacin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking gemifloxacin,
- tell your doctor and pharmacist if you are allergic or have had a severe reaction to gemifloxacin or any other quinolone or fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the U.S.), levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the U.S.); any other medications; or if you are allergic to any of the ingredients in gemifloxacin. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); certain antidepressants; antipsychotics (medications to treat mental illness); cisapride (Propulsid) (not available in the U.S.); diuretics ('water pills'); erythromycin (E.E.S., E-Mycin, Erythrocin, others); hormone replacement therapy; certain medications for irregular heartbeat such as amiodarone (Cordarone), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); or probenecid (in Col-Probenecid, Probalan). Your doctor will need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others); didanosine (Videx); sucralfate (Carafate); or vitamin or mineral supplements that contain iron, magnesium, or zinc, take these medications 3 hours before or 2 hours after you take gemifloxacin.
- tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or an irregular heartbeat, and if you have or have ever had nerve problems, a low level of potassium or magnesium in your blood, seizures, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or ministroke), a slow heartbeat, chest pain, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking gemifloxacin, call your doctor.
- you should know that gemifloxacin may cause confusion, dizziness, lightheadedness, and tiredness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.
- plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (sunlamps or tanning beds) and wear protective clothing, sunglasses, and sunscreen. Gemifloxacin may make your skin sensitive to sunlight or ultraviolet light. If your skin becomes reddened, swollen, or blistered, like a bad sunburn, call your doctor.
What SPECIAL DIETARY instructions should I follow?
Make sure you drink plenty of water or other fluids every day while you are taking gemifloxacin.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of gemifloxacin in one day.
What SIDE EFFECTS can this medicine cause?
Gemifloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately but do not stop taking gemifloxacin without talking to your doctor:
- severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
- hallucinations (seeing things or hearing voices that do not exist)
- not trusting others or feeling that others want to hurt you
- thoughts about dying or killing yourself
- difficulty falling asleep or staying asleep
- uncontrollable shaking of a part of the body
If you experience any of the following symptoms, or the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section, stop taking gemifloxacin and call your doctor immediately or get emergency medical help:
- peeling or blistering of the skin
- swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles or lower legs
- difficulty breathing or swallowing
- fast heartbeat
- loss of consciousness
- yellowing of the skin or eyes
- dark urine
- decreased urination
- unusual bruising or bleeding
- joint or muscle pain
Gemifloxacin may cause problems with bones, joints, and tissues around joints in children. Gemifloxacin should not be given to children younger than 18 years of age.
Gemifloxacin may cause nerve damage that may not go away even after you stop taking gemifloxacin. This damage may occur soon after you begin taking gemifloxacin. If you experience any of the following symptoms, call your doctor immediately: numbness, tingling, pain, or burning in the arms or legs; or a change in your ability to feel light touch, pain, heat, or cold. If you experience these symptoms, do not take any more gemifloxacin until you talk to your doctor. Your doctor may prescribe a different antibiotic for you to take instead of gemifloxacin.
Talk to your doctor about the risks of taking gemifloxacin or giving gemifloxacin to your child.
Gemifloxacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to gemifloxacin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking gemifloxacin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please note, not all procedures included in this resource library are available at Henry Ford Allegiance Health or performed by Henry Ford Allegiance Health physicians.
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