(oh floks' 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 ofloxacin 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 ofloxacin. If you have myasthenia gravis and your doctor tells you that you should take ofloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ofloxacin. 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 check the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Ofloxacin is used to treat certain infections including bronchitis, pneumonia, and infections of the skin, bladder, urinary tract, reproductive organs, and prostate (a male reproductive gland). Ofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics will not work for colds, flu, or other viral infections.
HOW should this medicine be used?
Ofloxacin comes as a tablet to take by mouth. It is usually taken with or without food twice a day for 3 days to 6 weeks. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take ofloxacin. Take ofloxacin at around the same times every day and try to space your doses 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You should begin to feel better during the first few days of your treatment with ofloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take ofloxacin until you finish the prescription, even if you feel better. Do not stop taking ofloxacin without talking to your doctor unless you experience certain serious side effects that are listed in the IMPORTANT WARNING and SIDE EFFECT sections. If you stop taking ofloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Are there OTHER USES for this medicine?
Ofloxacin is also sometimes used to treat other types of infection, including infections of the bones and joints and of the stomach and intestines. Ofloxacin may also be used to treat or prevent anthrax or plague (serious infections that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to the germs that cause these infections in the air. Talk to your doctor about the risks of using ofloxacin to treat your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking ofloxacin,
- tell your doctor and pharmacist if you are allergic or have had a severe reaction to ofloxacin; other quinolone or fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the United States), gemifloxacin (Factive), Levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the United States), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), and sparfloxacin (Zagam) (not available in the United States); or any other medications.
- 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: other antibiotics; anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); certain antidepressants; antipsychotics (medications to treat mental illness); cimetidine (Tagamet); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); insulin and oral medications for diabetes such as glyburide (DiaBeta, in Glucovance, Micronase, others); certain medications for irregular heartbeat such as amiodarone (Cordarone), quinidine, procainamide (Procanbid), and sotalol (Betapace, Betapace AF, Sorine); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); probenecid (in Col-Probenecid, Probalan); and theophylline (Elixophyllin, Theo-24, Uniphyl, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids containing aluminum, calcium, or magnesium (Maalox, Mylanta, Tums, others); didanosine (Videx); sucralfate (Carafate); or supplements or multivitamins containing iron or zinc, take ofloxacin 2 hours before or 2 hours after you take these medications.
- 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, seizures, a slow heartbeat, a low level of potassium in your blood, chest pain, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or mini-stroke), or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ofloxacin, call your doctor.
- you should know that this medication may cause dizziness, lightheadedness, and tiredness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how ofloxacin affects you.
- plan to avoid unnecessary or prolonged exposure to sunlight and ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen. Ofloxacin may make your skin sensitive to sunlight or ultraviolet light. If your skin becomes reddened, swollen, or blistered, 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 ofloxacin.
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 a double dose to make up for a missed one and do not take more than two doses of ofloxacin in one day.
What SIDE EFFECTS can this medicine cause?
Ofloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain or cramps
- change in ability to taste food
- loss of appetite
- dry mouth
- excessive tiredness
- pain, swelling, or itching of the vagina
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately, but do not stop taking ofloxacin 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)
- difficulty falling asleep or staying asleep
- uncontrollable shaking of a part of the body
- thoughts about killing or harming yourself
- not trusting others or feeling that others want to harm you
- vision changes
If you experience any of the following symptoms, or the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section, stop taking ofloxacin 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
Ofloxacin may cause problems with bones, joints, and tissues around joints in children. Ofloxacin should not be given to children younger than 18 years of age.
Ofloxacin may cause nerve damage that may not go away even after you stop taking ofloxacin. This damage may occur soon after you begin taking ofloxacin. 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 ofloxacin until you talk to your doctor. Your doctor may prescribe a different antibiotic for you to take instead of ofloxacin.
Talk to your doctor about the risks of taking ofloxacin or giving ofloxacin to your child.
Ofloxacin 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 excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
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.
Symptoms of overdose may include the following:
- hot and cold flushes
- numbness and swelling of the face
- slurred speech
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 ofloxacin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ofloxacin.
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 ofloxacin, 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.
- Also available generically
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