Factive (Gemifloxacin Mesylate)

(gem ah flox' a sin)

[Posted 07/10/2018] 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
• disorientation
• agitation
• nervousness
• 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:

• confusion
• pounding heart or very fast pulse
• dizziness
• pale skin
• feeling shaky
• sweating
• unusual hunger
• trembling
• headaches
• weakness
• irritability
• 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. 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 cause changes in sensation and nerve damage that may not go away even after you stop taking moxifloxacin. This damage may occur soon after you begin taking gemifloxacin. 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 gemifloxacin 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 gemifloxacin may affect your brain or nervous system and cause serious side effects. This can occur after the first dose of gemifloxacin. 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 gemifloxacin 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 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.

Gemifloxacin is used to treat pneumonia . Gemifloxacin may also be used to treat bronchitis but should not be used for this condition if there are other treatment options. Gemifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as gemifloxacin do 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.

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. Do not take gemifloxacin with dairy products such as milk or yogurt, or calcium-fortified juices alone. However, you may take gemifloxacin with a meal that includes these foods or drinks. 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.

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), delafloxacin (Baxdela), gatifloxacin (Tequin) (not available in the U.S.), 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 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., Eryc, Erythrocin, others); hormone replacement therapy; certain medications for irregular heartbeat such as amiodarone (Cordarone Nexterone, Pacerone), procainamide , quinidine, and sotalol (Betapace, Betapace AF, Sorine, Sotylize); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); or probenecid (Probalan in Col-Probenecid). 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, others); didanosine (Videx) solution; or vitamin or mineral supplements that contain iron, magnesium, or zinc, take gemifloxacin at least 2 hours before or 3 hours after you take these medications.
• if you are taking sucralfate (Carafate) take it at least 2 hours after you take gemifloxacin.
• Also 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 if you have or have ever had a slow or irregular heartbeat, or a heart attack, and if you have a low level of potassium or magnesium in your blood,
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking gemifloxacin, 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 (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.

Make sure you drink plenty of water or other fluids every day while you are taking gemifloxacin.

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.

Gemifloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• stomach pain
• vomiting
• pale skin
• unusual tiredness

If you experience any of the following symptoms, or any of the symptoms described in the IMPORTANT WARNING section, stop taking gemifloxacin 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)
• rash
• hives
• itching
• peeling or blistering of the skin
• fever
• swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles or lower legs
• hoarseness
• difficulty breathing or swallowing
• ongoing or worsening cough
• fast or fluttering heartbeat
• fainting
• loss of consciousness
• yellowing of the skin or eyes
• light colored stool
• 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 other side effects. Call your doctor if you have any unusual problems while taking 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. 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 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.

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.