AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems.
Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug.
RECOMMENDATION: The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:
- disturbances in attention
- memory impairment
- serious disturbances in mental abilities called delirium.
FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.
Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include:
- pounding heart or very fast pulse
- pale skin
- feeling shaky
- unusual hunger
- unusual anxiety
Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin.
- Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia.
- Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose.
- Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non-fluoroquinolone antibiotic if possible.
- Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient's treatment course.
Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Taking ciprofloxacin 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 ciprofloxacin, 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 ciprofloxacin 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 ciprofloxacin may cause changes in sensation and nerve damage that may not go away even after you stop taking ciprofloxacin. This damage may occur soon after you begin taking ciprofloxacin. Tell your doctor if you have ever had peripheral neuropathy (a type of nerve damage that causes tingling, numbness, and pain in the hands and feet). If you experience any of the following symptoms, stop taking ciprofloxacin and call your doctor immediately: numbness, tingling, pain, burning, or weakness in the arms or legs; or a change in your ability to feel light touch, vibrations, pain, heat, or cold.
Taking ciprofloxacin may affect your brain or nervous system and cause serious side effects. This can occur after the first dose of ciprofloxacin. Tell your doctor if you have or have ever had seizures, epilepsy, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or ministroke), stroke, changed brain structure, or kidney disease. If you experience any of the following symptoms, stop taking ciprofloxacin and call your doctor immediately: seizures; tremors; dizziness; lightheadedness; headaches that won't go away (with or without blurred vision); difficulty falling asleep or staying asleep; nightmares; not trusting others or feeling that others want to hurt you; hallucinations (seeing things or hearing voices that do not exist); thoughts or actions towards hurting or killing yourself; feeling restless, anxious, nervous, depressed, or confused, or other changes in your mood or behavior.
Taking ciprofloxacin 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 ciprofloxacin. If you have myasthenia gravis and your doctor tells you that you should take ciprofloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking ciprofloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ciprofloxacin. 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 medication prescribed?
Ciprofloxacin is used to treat or prevent certain infections caused by bacteria such as pneumonia; gonorrhea (a sexually transmitted disease); typhoid fever (a serious infection that is common in developing countries); infectious diarrhea (infections that cause severe diarrhea); and infections of the skin, bone, joint, abdomen (stomach area), and prostate (male reproductive gland), Ciprofloxacin is also used to treat or prevent plague (a serious infection that may be spread on purpose as part of a bioterror attack) and inhalation anthrax (a serious infection that may be spread by anthrax germs in the air on purpose as part of a bioterror attack). Ciprofloxacin may also be used to treat bronchitis, sinus infections, or urinary tract infections but should not be used for bronchitis and sinus infections, or certain types of urinary tract infections if there are other treatment options. Ciprofloxacin extended-release (long-acting) tablets are used to treat kidney and urinary tract infections; however, some types of urinary tract infections should only be treated with ciprofloxacin extended release tablets if no other treatment options are available. Ciprofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections.
Antibiotics such as ciprofloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
How should this medicine be used?
Ciprofloxacin comes as a tablet, a suspension (liquid), and an extended-release tablet to take by mouth with or without food. The tablets and suspension are usually taken twice a day, and the extended-release tablets are usually taken once a day. When used to treat gonorrhea, the tablets and suspension may be given as a single dose. Take ciprofloxacin at around the same time(s) every day. The length of your treatment depends on the type of infection you have. Your doctor will tell you how long to take ciprofloxacin. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ciprofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
One type of ciprofloxacin cannot be substituted for another. Be sure that you receive only the type of ciprofloxacin that was prescribed by your doctor. Ask your pharmacist if you have any questions about the type of ciprofloxacin you were given.
Do not take ciprofloxacin with dairy products or calcium-fortified juices alone. However, you may take ciprofloxacin with a meal that includes these foods or drinks.
Swallow the tablets and extended-release tablets whole; do not split, crush, or chew them. If you cannot swallow tablets whole, tell your doctor.
If you are taking the suspension, shake the bottle very well for 15 seconds before each use to mix the medication evenly. Swallow the correct dose without chewing the granules in the suspension. Close the bottle completely after each use. Do not give the suspension to a patient through a feeding tube.
You should begin feeling better during the first few days of your treatment with ciprofloxacin. If your symptoms do not improve or if they get worse, call your doctor. If you are being treated for a urinary tract infection, call your doctor if you develop fever or back pain during or after your treatment. These symptoms may be signs that your infection is worsening.
Take ciprofloxacin until you finish the prescription, even if you feel better. Do not stop taking ciprofloxacin without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING and SIDE EFFECTS sections If you stop taking ciprofloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicine
In the event of biological warfare, ciprofloxacin may be used to treat and prevent dangerous illnesses that are deliberately spread such as tularemia and anthrax of the skin or mouth. Ciprofloxacin is also sometimes used to treat cat scratch disease (an infection that may develop after a person is bitten or scratched by a cat), Legionnaires' disease (type of lung infection), chancroid (genital sores caused by bacteria), granuloma inguinale (donovanosis; a sexually transmitted disease), and infections of the outer ear that spread to the bones of the face. Ciprofloxacin may also be used to help treat tuberculosis and Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever). Ciprofloxacin is also sometimes used to prevent traveler's diarrhea in certain patients and to prevent infections in patients who have fever and are at high risk for infection because they have very few white blood cells, people who are having certain types of surgery, and those people in close contact with someone who is sick with itis. Talk to your doctor about the risks of using this medication for 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 ciprofloxacin,
- tell your doctor and pharmacist if you are allergic or have had a severe reaction to ciprofloxacin. any other quinolone or fluoroquinolone antibiotic such as delafloxacin (Baxdela), gatifloxacin (Tequin) (not available in the U.S.), gemifloxacin (Factive), levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram) (not available in the U.S.), norfloxacin (Noroxin) (not available in the U.S.), 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 ciprofloxacin tablets or suspension. Ask your doctor or pharmacist for a list of the ingredients.
- tell your doctor if you are taking tizanidine (Zanaflex). Your doctor will probably tell you not to take ciprofloxacin while you are taking this medication.
- 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) such as clozapine (Clozaril, Fazaclo, Versacloz) and olanzapine (Zyprexa, in Symbax); azthizromycin (Zithromax, Zmax); caffeine or medications that contain caffeine (Excedrin, NoDoz, Vivarin, others); clarithromycin (Biaxin, in Prevpac); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); duloxetine (Cymbalta); erythromycin (E.E.S., Eryc, Eryped, others); certain medications for irregular heartbeat such as amiodarone (Cordarone, Nexterone, Pacerone), disopyramide (Norpace), procainamide, quinidine, and sotalol (Betapace, Betapace AF, Sorine, Sotylize); methotrexate (Otrexup, Rasuvo, Trexall); medications for diabetes that are taken by mouth such as glimepiride (Amaryl, in Duetact), and glyburide (DiaBeta, Glynase, in Glucovance); certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); pentoxifylline (Pentoxil); phenytoin (Dilantin, Phenytek); probenecid (Probalan, in Col-Probenecid); ropinirole (Requip); sildenafil (Revatio, Viagra); theophylline (Elixophyllin, Theo-24, Uniphyl, others); tizanidine (Zanaflex); or zolpidem (Ambien, Edluar, Intermezzo, Zolpimist). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ciprofloxacin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- if you are taking antacids containing calcium, aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others); didanosine (Videx) solution; calcium, iron, or zinc supplements; phosphate binders such as sevelamer (Renagel, Renvela) or lanthanum carbonate (Fosrenol); or sucralfate (Carafate), take ciprofloxacin at least 2 hours before, or 6 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) if you have or have ever had an irregular heartbeat, heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body), a heart attack, or a slow heartbeat; or have a low level of potassium or magnesium in your blood. Also tell your doctor if you have or have ever had liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ciprofloxacin, call your doctor.
- 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 (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen. Ciprofloxacin 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?
Do not drink or eat a lot of caffeine-containing products such as coffee, tea, energy drinks, cola, or chocolate. Ciprofloxacin may increase nervousness, sleeplessness, heart pounding, and anxiety caused by caffeine.
Make sure you drink plenty of water or other fluids every day while you are taking ciprofloxacin.
What should I do if I forget a dose?
If you miss a dose of ciprofloxacin, 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. Do not take more than two doses of the tablets or suspension or more than one dose of the extended-release tablets in one day.
What side effects can this medication cause?
Ciprofloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- vaginal itching and/or discharge
- pale skin
- unusual tiredness
If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, stop taking ciprofloxacin and call your doctor immediately or get emergency medical help:
- 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)
- 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
- ongoing or worsening cough
- fast or fluttering heartbeat
- loss of consciousness
- yellowing of the skin or eyes
- dark urine
- light colored stool
- decreased urination
- unusual bruising or bleeding
- joint or muscle pain
Ciprofloxacin may cause problems with bones, joints, and tissues around joints in children. Ciprofloxacin should not normally be given to children younger than 18 years of age unless they have certain serious infections that cannot be treated with other antibiotics or they have been exposed to plague or anthrax in the air. If your doctor prescribes ciprofloxacin for your child, be sure to tell the doctor if your child has or has ever had joint-related problems. Call your doctor if your child develops joint problems such as pain or swelling while taking ciprofloxacin or after treatment with ciprofloxacin.
Talk to your doctor about the risks of taking ciprofloxacin or giving ciprofloxacin to your child.
Ciprofloxacin 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 the tablets and extended-release tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension in the refrigerator or at room temperature, closed tightly, for up to 14 days. Do not freeze ciprofloxacin suspension. Discard any suspension that is left over after 14 days.
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.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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 ciprofloxacin.
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 ciprofloxacin, 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.
¶ This branded product is no longer on the market. Generic alternatives may be available.