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Explains the medication levofloxacin Levaquin, a drug used to treat infections of the sinuses, skin, lungs, ears, airways, bones, and joints caused by susceptible. \r\n\r\nFluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions (5.1)]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin Tablets and other antibacterial drugs, Levofloxacin Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin Tablets, USP are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with Levofloxacin Tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Levofloxacin Tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. Inhalational Anthrax (Post-Exposure) Levofloxacin tablet, USP is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablet is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablet has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Levofloxacin Tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged Levofloxacin Tablets therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. Plague Levofloxacin tablet, USP is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of Levofloxacin Tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)]. Levofloxacin Tablets Levofloxacin Tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets [see Drug Interactions (7.1) and Patient Counseling Information (17.2)]. Food and Levofloxacin Tablets Levofloxacin Tablets can be administered without regard to food. Hydration for Patients Receiving Levofloxacin Tablets Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. Dosage Forms and Strengths Levofloxacin Tablets, USP are white to off white, modified capsule-shaped, biconvex and film-coated NDC 68382-015-18 in bottles of 50 tablets NDC 68382-015-01 in bottles of 100 tablets NDC 68382-015-05 in bottles of 500 tablets Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied as follows: NDC 68382-016-18 in bottles of 50 tablets NDC 68382-016-01 in bottles of 100 tablets NDC 68382-016-05 in bottles of 500 tablets NDC 68382-016-10 in bottles of 1000 tablets Levofloxacin Tablets USP, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC57' on one side and plain on other side and are supplied as follows: NDC 68382-017-18 in bottles of 50 tablets NDC 68382-017-01 in bottles of 100 tablets NDC 68382-017-05 in bottles of 500 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP. MEDICATION GUIDE Levofloxacin Tablets, USP (LEE voe FLOX a sin) Read this Medication Guide before you start taking levofloxacin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about levofloxacin? Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death. If you have any of the following serious side effects while you take levofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin. a steroid medicine. an anti-psychotic medicine a tricyclic antidepressant a water pill (diuretic) certain medicines may keep levofloxacin from working correctly. Take Levofloxacin Tablets either 2 hours before or 2 hours after taking these medicines or supplements: an antacid, multivitamin, or other medicines or supplements that have magnesium, aluminum, iron, or zinc sucralfate (Carafate®*) didanosine (Videx®*,Videx®* EC) a blood thinner (warfarin, Coumadin, Jantoven) an oral anti-diabetes medicine or insulin an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. theophylline (Theo-24®*, Elixophyllin®*, Theochron®*, Uniphyl®*, Theolair®*) a medicine to control your heart rate or rhythm (antiarrhythmics) Sensitivity to sunlight (photosensitivity) See "What should I avoid while taking levofloxacin?" The most common side effects of levofloxacin include: ° nausea ° headache ° diarrhea ° insomnia ° constipation ° dizziness In children 6 months and older who take levofloxacin to treat anthrax disease or plague, vomiting is also common. Levofloxacin may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test. These are not all the possible side effects of levofloxacin. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store levofloxacin? Store levofloxacin film-coated tablets at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP. Keep levofloxacin and all medicines out of the reach of children. General Information about the safe and effective use of levofloxacin Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levofloxacin for a condition for which it is not prescribed. Do not give levofloxacin to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about levofloxacin. If you would like more information about levofloxacin, talk with your healthcare provider. Please address medical inquiries to, ([email protected]) Tel.: 1-877-993-8779. What are the ingredients in Levofloxacin Tablets, USP? Active ingredients: levofloxacin, USP Inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide. *are the registered trademarks of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration. This product's label may have been updated. For current full prescribing information, please visit www.zydususa.com.\',\'url\':\'http://www.drugs.com/pro/levofloxacin-tablets.html\',\'og_descr\':\'Levofloxacin Tablets official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. \r\n\r\nWhat are the ingredients in Levaquin? \r\nLevaquin is an antibiotic used to treat certain bacterial infections, including bronchitis, pneumonia, and sinus, skin, prostate, urinary tract, or kidney infections. \r\nLearn about the prescription medication Levaquin Levofloxacin, drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. \r\nLevaquin official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. \r\nLevofloxacin Tablets official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. \r\n250 mg Levaquin Film-Coated Tablets: Active ingredient: levofloxacin.Inactive ingredients: hypromellose, crospovidone, micro-crystalline cellulose.\r\nLevaquin Oral Solution may look clear yellow to clear greenish-yellow in color. Levaquin Injection in Single-Use Vials: Active ingredient: levofloxacin. Inactive ingredients: water for injection. Levaquin for Injection Single Use Vials do not contain any preservatives. Important: The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, blogs, or WebMD Answers are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD. User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. Some of these opinions may contain information about treatments or uses of drug products that have not been approved by the U.S. Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment. Do not consider WebMD User-generated content as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on WebMD. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. WebMD understands that reading individual, real-life experiences can be a helpful resource, but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately.
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