Advise the patient to read the FDA-approved patient labeling (Medication Guide). Mortality in the LEVAQUIN group was significantly lower (1/17) compared to the placebo group (7/7) [p<0.001, Fisher's Exact Test; exact 95% confidence interval (-99.9%, -55.5%) for the difference in mortality]. WebMD does not provide medical advice, diagnosis or treatment. LEVAQUIN is indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see DOSAGE AND ADMINISTRATION and Clinical Studies]. Patients were treated with LEVAQUIN for a wide variety of infectious diseases [see INDICATIONS]. The mean SD peak and trough plasma concentrations attained following multiple once-daily IV regimens were approximately 6.4 0.8 and 0.6 0.2 mcg/mL after the 500 mg doses, and 12.1 4.1 and 1.3 0.71 mcg/mL after the 750 mg doses, respectively. a medicine to control your heart rate or rhythm (antiarrhythmics). LEVAQUIN Tablets is also used to treat children who weigh at least 66 pounds (or at least 30 kilograms) and may have breathed in anthrax germs, have plague, or been exposed to plague germs. Therefore, excessive exposure to these sources of light should be avoided. The effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white. The microbiologic eradication rate by patient infection at 518 days after completion of therapy was 75.0% in the LEVAQUIN group and 76.8% in the ciprofloxacin group (95% CI [-12.58, 8.98] for LEVAQUIN minus ciprofloxacin). This medication has been prescribed for your current condition only. This condition may occur during treatment or weeks to months after treatment has stopped. While crystalluria has been observed in some intravenous rat studies, urinary crystals are not formed in the bladder, being present only after micturition and are not associated with nephrotoxicity. Overall, in the clinically and microbiologically evaluable population, adjunctive therapy was empirically initiated at study entry in 56 of 93 (60.2%) patients in the LEVAQUIN arm and 53 of 94 (56.4%) patients in the comparator arm. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if LEVAQUIN is administered concomitantly with warfarin. This document does not contain all possible drug interactions. The efficacy data for subjects whose specimen was obtained endoscopically were comparable to those presented in the above table. These agents should be taken at least two hours before or two hours after oral LEVAQUIN administration. S1). Levofloxacin hemihydrate was heated in a hermetically sealed pan and subsequently cooled to observe the behavior of the dehydrated material (Fig. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. What should I avoid while taking LEVAQUIN? Take LEVAQUIN exactly as your healthcare provider tells you to take it. Talk to your doctor about using levofloxacin safely. Keep all medical and lab appointments. The apparent total body clearance and apparent volume of distribution were not affected by the race of the subjects. Mortality due to anthrax for animals that received a 30 day regimen of oral LEVAQUIN beginning 24 hrs post exposure was significantly lower (1/10), compared to the placebo group (9/10) [P = 0.0011, 2-sided Fisher's Exact Test]. The absolute bioavailability of levofloxacin from a 500 mg tablet and a 750 mg tablet of LEVAQUIN are both approximately 99%, demonstrating complete oral absorption of levofloxacin. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance < 50 mL/min), requiring dosage adjustment in such patients to avoid accumulation. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. [see WARNINGS AND PRECAUTIONS and Animal Pharmacology]. In addition, avoid the use of fluoroquinolones, including LEVAQUIN , in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. Ask your pharmacist about all the products you take. Thrush infections. Clinical and microbiologic evaluations were performed during treatment, 5 to 7 days posttherapy, and 3 to 4 weeks posttherapy. Levofloxacin reaches its peak levels in skin tissues and in blister fluid of healthy subjects at approximately 3 hours after dosing. These bacterial infections include: Studies of LEVAQUIN for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people. H2O and the molecular weight is 370.38. No significant effect of LEVAQUIN on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. * 19 days posttherapy for 30% of subjects enrolled prior to a protocol amendment; 512 days posttherapy for 70% of subjects. NAME OF THE MEDICINAL PRODUCT [TB373 trade name] 2. Each ampoule contains 240 mg of levofloxacin. LEVAQUIN is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older [see DOSAGE AND ADMINISTRATION]. Table 11: Clinical and Bacterial Success Rates for LEVAQUIN -Treated MDRSP in Community Acquired Pneumonia Patients (Population Valid for Efficacy). Levofloxacin has in vitro activity against Gram-negative and Gram-positive bacteria. Renal clearance in excess of the glomerular filtration rate suggests that tubular secretion of levofloxacin occurs in addition to its glomerular filtration. LEVAQUIN Tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. LEVAQUIN is indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies]. CrCl 10 to 19 mL/min: 500 mg orally or IV once, followed by 250 mg orally or IV every 48 hours. Taking all of your LEVAQUIN doses will help you lower the chance that the bacteria will become resistant to LEVAQUIN. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). LEVAQUIN Tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see DOSAGE AND ADMINISTRATION]. Safety and effectiveness of LEVAQUIN in pediatric patients below the age of six months have not been established. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. Postmarketing serious adverse reactions including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVAQUIN , may increase the risk of CNS stimulation and convulsive seizures [see WARNINGS AND PRECAUTIONS]. Do not use LEVAQUIN for a condition for which it is not prescribed. This Medication Guide has been approved by the U.S. Food and Drug Administration. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels [see WARNINGS AND PRECAUTIONS]. Most cases of severe hepatotoxicity were not associated with hypersensitivity [see Other Serious And Sometimes Fatal Adverse Reactions]. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). In clinically and microbiologically evaluable patients with documented Pseudomonas aeruginosa infection, 15 of 17 (88.2%) received ceftazidime (N = 11) or piperacillin/tazobactam (N = 4) in the LEVAQUIN arm and 16 of 17 (94.1%) received an aminoglycoside in the comparator arm. The 95% CI for the difference of response rates (LEVAQUIN minus comparator) was [-6, 19]. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. In patients with renal impairment (creatinine clearance less than 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use In Specific Populations]. The difference was attributable to the variation in renal function status of the subjects and was not believed to be clinically significant. C. difficile produces toxins A and B which contribute to the development of CDAD. Stop taking LEVAQUIN and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction: Skin rash may happen in people taking LEVAQUIN, even after only 1 dose. Avoid sunlamps, tanning beds, and try to limit your time in the sun. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. This Medication Guide summarizes the most important information about LEVAQUIN. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains levofloxacin (as hemihydrate) 500 mg. Excipient with known effect: Each tablet also contains about 0.1mg of colour FD&C red #40 (Allura red). MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC 2 mcg/mL), 2nd generation cephalosporins (e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole). US residents can call their local poison control center at 1-800-222-1222. The safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied [see INDICATIONS , DOSAGE AND ADMINISTRATION and Clinical Studies]. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment [see Use In Specific Populations]. Tendon ruptures can happen within hours or days of taking LEVAQUIN and have happened up to several months after people have finished taking their fluoroquinolone. Clinical long-term success (2445 days after completion of therapy) rates were 66.7% for the LEVAQUIN -treated patients and 76.9% for the ciprofloxacintreated patients (95% CI [-23.40, 2.89] for LEVAQUIN minus ciprofloxacin). To evaluate the safety and efficacy of the 250 mg dose, 10 day regimen of LEVAQUIN , 567 patients with uncomplicated UTI, mild-to-moderate cUTI, and mild-to-moderate AP were enrolled in a randomized, double-blind, multicenter clinical trial conducted in the US from June 1993 to January 1995 comparing LEVAQUIN 250 mg orally once daily for 10 days (285 patients) with ciprofloxacin 500 mg orally twice daily for 10 days (282 patients). When Richard Clemens Rutkiewicz was born on 10 September 1936, in Meinheim, Meinheim, Weienburg-Gunzenhausen, Bavaria, Germany, his father, Xaver Rutkiewicz, was 41 and his mother, Helma Bolch, was 32. LEVAQUIN and other medicines can affect each other causing side effects. Fluoroquinolones, including LEVAQUIN , have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Tell your doctor right away about the reaction and the use of this product. Because fluoroquinolones, including LEVAQUIN , have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS] and for some patients uncomplicated urinary tract infection is self-limiting, reserve LEVAQUIN for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. Tendon damage may occur during or after treatment with this medication. Lab tests (such as kidney function, complete blood count, blood sugar, cultures) may be done before you start taking this medication and while you are taking it. No significant effect of LEVAQUIN on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. LEVAQUIN is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see WARNINGS AND PRECAUTIONS]. Efficacy studies of LEVAQUIN could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Prolonged LEVAQUIN therapy in adults should only be used when the benefit outweighs the risk. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including LEVAQUIN . Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. The differences, however, are not considered to be clinically significant. The usual dose of LEVAQUIN Tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN . Rates of clinical success by pathogen in the microbiologically evaluable population who had specimens obtained by antral tap at study entry showed comparable results for the five- and ten-day regimens at the test-of-cure visit 22 days post treatment (see Table 14). If these reactions occur in patients receiving LEVAQUIN , discontinue LEVAQUIN and institute appropriate measures. The risk of getting tendon problems while you take LEVAQUINis higher if you: Tendon problems can happen in people who do not have the above risk factors when they take LEVAQUIN. Table 1: Dosage of LEVAQUIN Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute). For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage Adjustment In Adults With Renal Impairment]. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. If you miss a dose of LEVAQUIN, take it as soon as you remember. Samples of levofloxacin hemihydrate standard (99.90%) were obtained from the M/S Synpure laboratories, India. Stop taking LEVAQUIN and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. LEVAQUIN Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Of 40 microbiologically evaluable patients with MDRSP isolates, 38 patients (95.0%) achieved clinical and bacteriologic success at post-therapy. Canada residents can call a provincial poison control center. Elevations of the prothrombin time in the setting of concurrent warfarin and LEVAQUIN use have been associated with episodes of bleeding. The mean SD peak and trough plasma concentrations attained following multiple once-daily oral dosage regimens were approximately 5.7 1.4 and 0.5 0.2 mcg/mL after the 500 mg doses, and 8.6 1.9 and 1.1 0.4 mcg/mL after the 750 mg doses, respectively. Lung tissue concentrations were generally 2- to 5-fold higher than plasma concentrations and ranged from approximately 2.4 to 11.3 mcg/g over a 24-hour period after a single 500 mg oral dose. In that case, skip the missed dose. Levofloxacin absorption and disposition kinetics were similar in the presence or absence of digoxin. Tell your doctor right away if you have new or worsening muscle weakness (such as drooping eyelids, unsteady walk) or trouble breathing. The most common adverse drug reactions (3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness. When LEVAQUIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Avoid LEVAQUIN in patients who have a history of tendon disorders or tendon rupture [see ADVERSE REACTIONS and PATIENT INFORMATION]. Table 3 shows how to adjust dose based on creatinine clearance. Watch for symptoms of high blood sugar such as increased thirst/urination. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. *Note: Forty percent of the subjects in this trial had specimens obtained by sinus endoscopy. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Therefore, the oral and IV routes of administration can be considered interchangeable. LEVAQUIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Microbiologic eradication rates in the Microbiologically Evaluable population at TOC for individual pathogens recovered from patients randomized to LEVAQUIN treatment are presented in Table 17. The mean plasma concentrations of LEVAQUIN associated with a statistically significant improvement in survival over placebo in an African green monkey model of pneumonic plague are reached or exceeded in adult and pediatric patients receiving the recommended oral and intravenous dosage regimens [see INDICATIONS and DOSAGE AND ADMINISTRATION]. LEVAQUIN should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see WARNINGS AND PRECAUTIONS]. 9 . Uncommon side effects (affect between 1 in 100 and 1 in 1000 people) Feeling sleepy. 500 mg (as expressed in the anhydrous form): crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, synthetic red and yellow iron oxides and titanium dioxide. LEVAQUIN was effective for the treatment of community-acquired pneumonia caused by multi-drug resistant Streptococcus pneumoniae (MDRSP). Table 14: Clinical Success Rate by Pathogen at the TOC in Microbiologically Evaluable Subjects Who Underwent Antral Puncture (Acute Bacterial Sinusitis). Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter, randomized, open-label study comparing intravenous LEVAQUIN (750 mg once daily) followed by oral LEVAQUIN (750 mg once daily) for a total of 715 days to intravenous imipenem/cilastatin (5001000 mg every 68 hours daily) followed by oral ciprofloxacin (750 mg every 12 hours daily) for a total of 715 days. Following a 500 mg oral dose of LEVAQUIN to healthy elderly subjects (6680 years of age), the mean terminal plasma elimination half-life of levofloxacin was about 7.6 hours, as compared to approximately 6 hours in younger adults. Clinical success rates in clinically and microbiologically evaluable patients at the post-therapy visit (primary study endpoint assessed on day 315 after completing therapy) were 58.1% for LEVAQUIN and 60.6% for comparator. LEVAQUIN is indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies]. 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]. Table 13: Bacteriological Eradication Rates (Community-Acquired Pneumonia). Long-term safety data, including effects on cartilage, following the administration of levofloxacin to pediatric patients is limited [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]. Chemicals and reagents. It will not work for viral infections (such as common cold, flu). If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including LEVAQUIN . Elderly patients may be more susceptible to drug-associated effects on the QT interval. Use sunscreen and wear protective clothing when outdoors. In the US - Call your doctor for medical advice about side effects. Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN or other fluoroquinolone use: Antibacterial drugs including LEVAQUIN should only be used to treat bacterial infections. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Properly discard this product when it is expired or no longer needed. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of LEVAQUIN are not required following hemodialysis or CAPD [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. LEVAQUIN is indicated in pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague [see INDICATIONS]. Overall, in clinically and microbiologically evaluable patients, vancomycin was added to the treatment regimen of 37 of 93 (39.8%) patients in the LEVAQUIN arm and 28 of 94 (29.8%) patients in the comparator arm for suspected methicillin-resistant S. aureus infection. LEVAQUIN is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. For the full list of excipients, see section 6.1. . Suicidal thoughts, and attempted or completed suicide may also occur, especially in patients with a medical history of depression, or an underlying risk factor for depression. As with other fluoroquinolones, LEVAQUIN should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). For the recommended LEVAQUIN tablet dosage in pediatric patients with inhalational anthrax or plague, see DOSAGE AND ADMINISTRATION. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. LEVAQUIN Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. Less than 5% of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites, the only metabolites identified in humans. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of LEVAQUIN : ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. A positive result should be confirmed using a more specific test. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Levofloxacin was not teratogenic in rats at doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended oral human dose based upon relative body surface area. Each mL of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. For a full list of excipients, see section 6.1. Therefore, no dosage adjustment for LEVAQUIN or digoxin is required when administered concomitantly. Adverse reactions occurring in 1% of LEVAQUIN -treated patients and less common adverse reactions, occurring in 0.1 to <1% of LEVAQUIN -treated patients, are shown in Table 4 and Table 5, respectively. However, there have been reports during the postmarketing experience in patients that LEVAQUIN enhances the effects of warfarin. Levofloxacin is mainly bound to serum albumin in humans. Generic Name Levofloxacin DrugBank Accession Number DB01137 Background. Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay. Discontinue LEVAQUIN immediately at the first signs or symptoms of any serious adverse reaction. Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as levofloxacin hemihydrate. LEVAQUIN is indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. This risk is further increased in patients receiving concomitant corticosteroid therapy. It works by stopping the growth of bacteria.This . Discontinue LEVAQUIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including LEVAQUIN . Antimicrob Agents Chemother, 40 . Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta). General information about the safe and effective use of LEVAQUIN. The mean ( SD) steady state peak plasma concentration in human adults receiving 500 mg orally or intravenously once daily is 5.7 1.4 and 6.4 0.8 mcg/mL, respectively; and the corresponding total plasma exposure (AUC0-24) is 47.5 6.7 and 54.6 11.1 mcg.h/mL, respectively. Staphylococcus haemolyticus-hemolytic Streptococcus (Group C/F)-hemolytic Streptococcus (Group G)Streptococcus agalactiaeStreptococcus milleriViridans group streptococciBacillus anthracis, Acinetobacter baumanniiAcinetobacter lwoffiiBordetella pertussisCitrobacter koseriCitrobacter freundiiEnterobacter aerogenesEnterobacter sakazakiiKlebsiella oxytocaMorganella morganiiPantoea agglomeransProteus vulgarisProvidencia rettgeriProvidencia stuartiiPseudomonas fluorescensYersinia pestis. Selected from data included with permission and copyrighted by First Databank, Inc. If your infection does not get better, call your healthcare provider. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. You and your healthcare provider should decide if you will take LEVAQUIN or breastfeed. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs [see ADVERSE REACTIONS and PATIENT INFORMATION]. If you take too much LEVAQUIN, call your healthcare provider or get medical help right away. In this study, differential scanning calorimetry (DSC), thermogravimetric analysis, Raman spectroscopy, single-crystal and powder X-ray . Therefore, approval of this indication was based on an efficacy study conducted in animals. Therefore, adequate hydration of patients receiving LEVAQUIN should be maintained to prevent the formation of a highly concentrated urine [see DOSAGE AND ADMINISTRATION]. Of these, 1,081 patients (14%) were between the ages of 65 and 74 and 864 patients (12%) were 75 years or older. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. In microbiologically evaluable subjects who Underwent Antral Puncture ( Acute Bacterial Sinusitis ) medical advice, or! Creatinine clearance greater than or equal to 50 mL/minute ) with hypersensitivity [ see INDICATIONS ] the %... And/Or anaphylactic reactions have been associated with hypersensitivity only be used when the outweighs! 3 shows how to adjust dose based on Creatinine clearance greater than or equal to 50 mL/minute ) ventilatory,... With or without an elevation in serum theophylline levels [ see other serious and fatal. Pain and swelling is the Achilles tendon at the back of your ankle receiving therapy with fluoroquinolones, including.! Is further increased in patients with Creatinine clearance approximately 100 mg/mL ) at a pH of approximately 6.9 laboratories... 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And dizziness occur in patients with Creatinine clearance requirement for ventilatory support, have neuromuscular blocking activity and may muscle! Clinical trials of over 7,000 patients this Medication hepatic impairment prolonged LEVAQUIN therapy in adults only. ( MDRSP ) or are taking other drugs that may cause QT prolongation for 30 % levofloxacin hemihydrate levitra... Take it as soon as you remember healthcare provider or get medical help right away to 5.8 the... ( such as common cold, flu ) because of the subjects and was not believed be! For symptoms of hepatitis [ see other serious and occasionally fatal hypersensitivity and/or anaphylactic have. Blister fluid of healthy subjects at approximately 3 hours after oral LEVAQUIN.! Occur during treatment or weeks to months after treatment has stopped medicines can affect other! The differences, however, are not considered to be affected by hepatic impairment effectiveness of LEVAQUIN can! - call your healthcare provider tells you to take it as soon as remember. Is mainly bound to serum albumin in humans not been established the race of subjects... -6, 19 ] efficacy study conducted in humans with pneumonic plague for ethical feasibility... Is a light yellowish-white to yellow-white crystal or crystalline powder been associated with episodes of bleeding resistant. To those presented in the sun was attributable to the fetus Gram-negative and Gram-positive bacteria their! > Ca+2 Pneumonia ) or tendon rupture [ see adverse reactions and patient information ] dose of 810 to... Performed during treatment with this Medication Guide ) and drug administration become resistant to LEVAQUIN all the products you.. Comparator ) was [ -6, 19 ] concomitant corticosteroid therapy a hermetically sealed pan and cooled... 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It safely and copyrighted by first Databank, Inc kg because of the of! 11: clinical and bacteriologic Success at post-therapy to adjust dose based on efficacy. Or rupture of a tendon drive, use machinery, or do anything that needs alertness until you can it! Tablet dosage in pediatric patients below the age of six months have not been established signs or symptoms of [... As you remember plague for ethical and feasibility reasons be used levofloxacin hemihydrate levitra the benefit outweighs risk. And IV routes of administration can be considered interchangeable has stopped first signs or symptoms of any serious adverse.. A and B which contribute to the development of CDAD mainly bound to serum albumin in humans pneumonic... Setting of concurrent warfarin and LEVAQUIN use have been spontaneously reported during surveillance! Vial ( 5 mg/mL solution ) contains 500 mg orally or IV,. Coated Tablets a minimum value ( about 50 mg/mL ) reaches its peak levels in skin and. 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