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Factive (Gemifloxacin Mesylate)
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Gemifloxacin Mesylate Information
(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
- memory impairment
- serious disturbances in mental abilities called delirium.
- pounding heart or very fast pulse
- pale skin
- feeling shaky
- unusual hunger
- unusual anxiety
- 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.
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.
- stomach pain
- pale skin
- unusual tiredness
- 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
- light colored stool
- dark urine
- decreased urination
- unusual bruising or bleeding
- joint or muscle pain