TAVANIC (Levofloxacin) 500mg

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TAVANIC (Levofloxacin) 500mg

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What is Levaquin/Tavanic (Levofloxacin) ?
Levaquin/Tavanic (Levofloxacin)  is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Levaquin/Tavanic (Levofloxacin)  fights bacteria in the body.Levaquin/Tavanic (Levofloxacin)  is used to treat bacterial infections of the skin, sinuses, kidneys, bladder, or prostate. Levaquin/Tavanic (Levofloxacin) is also used to treat bacterial infections that cause bronchitis or pneumonia, and to treat people who have been exposed to anthrax.Levaquin/Tavanic (Levofloxacin)  may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Levaquin/Tavanic (Levofloxacin) ?
You should not use this medication if you are allergic to Levaquin/Tavanic (Levofloxacin)  or similar antibiotics such as ciprofloxacin (Cipro), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others. Before taking Levaquin/Tavanic (Levofloxacin) , tell your doctor if you have kidney or liver disease, myasthenia gravis, joint problems, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Levaquin/Tavanic (Levofloxacin) . These other medicines can make Levaquin/Tavanic (Levofloxacin)  much less effective when taken at the same time. Taking Levaquin/Tavanic (Levofloxacin)  can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.Levaquin/Tavanic (Levofloxacin)  may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Levaquin/Tavanic (Levofloxacin) and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have. 


What should I discuss with my healthcare provider before taking Levaquin/Tavanic (Levofloxacin) ?
You should not use this medication if you are allergic to Levaquin/Tavanic (Levofloxacin)  or other fluoroquinolones such as ciprofloxacin (Cipro), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others. Before taking Levaquin/Tavanic (Levofloxacin) , tell your doctor if you have a heart rhythm disorder, especially if you are being treated with one of these medications: quinidine (Cardioquin, Quinidex, Quinaglute), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace).If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Levaquin/Tavanic (Levofloxacin) , tell your doctor if you have:a history of allergic reaction to an antibiotic; myasthenia gravis;joint problems;kidney or liver disease; seizures or epilepsy;diabetes;low levels of potassium in your blood (hypokalemia); ora personal or family history of "Long QT syndrome."FDA pregnancy category C: It is not known whether Levaquin/Tavanic (Levofloxacin)  is harmful to an unborn baby. Do not use ciprofloxacin without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Levaquin/Tavanic (Levofloxacin)  can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Levaquin/Tavanic (Levofloxacin)  may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Levaquin/Tavanic (Levofloxacin)  and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have. 


How should I take Levaquin/Tavanic (Levofloxacin) ?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take Levaquin/Tavanic (Levofloxacin)  with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking Levaquin/Tavanic (Levofloxacin) . You may take Levaquin/Tavanic (Levofloxacin)  tablets with or without food.Take Levaquin/Tavanic (Levofloxacin)  oral solution (liquid) on an empty stomach 1 hour before or 2 hours after meals. Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may improve before the infection is completely cleared. Levaquin/Tavanic (Levofloxacin)  will not treat a viral infection such as the common cold or flu. This medicine can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Levaquin/Tavanic (Levofloxacin) .


Store this medication at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. 


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medicine. Overdose symptoms may include loss of balance or coordination, drooping eyelids, weakness, decreased activity, trouble breathing, sweating, tremors, or seizure (convulsions). What should I avoid while taking Levaquin/Tavanic (Levofloxacin) ?You may be taking certain other medicines that should not be taken at the same time as Levaquin/Tavanic (Levofloxacin) . Avoid taking the following medicines within 2 hours before or after you take Levaquin/Tavanic (Levofloxacin) . These other medicines can make Levaquin/Tavanic (Levofloxacin)  much less effective when taken at the same time: antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids);the ulcer medicine sucralfate (Carafate);didanosine (Videx) powder or chewable tablets; orvitamin or mineral supplements that contain iron or zinc.Avoid exposure to sunlight, sunlamps, or tanning beds. Levaquin/Tavanic (Levofloxacin)  can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use a sunscreen (SPF-15 or higher) if you must be out in the sun. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.Levaquin/Tavanic (Levofloxacin)  can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. 


Side effects of Levaquin/Tavanic (Levofloxacin)  
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Levaquin/Tavanic (Levofloxacin)  and call your doctor at once if you have a serious side effect such as: dizziness, fainting, fast or pounding heartbeat;sudden pain or swelling near your joints (especially in your arm or ankle);diarrhea that is watery or bloody;confusion, hallucinations, depression, unusual thoughts or behavior;seizure (convulsions);pale or yellowed skin, dark colored urine, fever, weakness;urinating less than usual or not at all;easy bruising or bleeding;numbness, burning, pain, or tingly feeling in your hands or feet;fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; orthe first sign of any skin rash, no matter how mild.


Less serious side effects may include:
nausea, diarrhea, constipation;feeling restless, anxious, or depressed;headache, dizziness;muscle pain;sleep problems (insomnia or nightmares);vaginal itching or discharge; ormild skin itching.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 


What other drugs will affect Levaquin/Tavanic (Levofloxacin) ?
Before taking Levaquin/Tavanic (Levofloxacin) , tell your doctor if you are also using any of the following drugs:a blood thinner such as warfarin (Coumadin);insulin or diabetes medication you take by mouth, such as glyburide (Micronase, Diabeta, Glynase);a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), etodolac (Lodine), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), nabumetone (Relafen), meloxicam (Mobic), naproxen (Aleve, Naprosyn, Anaprox), piroxicam (Feldene), and others; oran oral steroid medication such as betamethasone (Celestone), dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), prednisolone (Orapred), prednisone (Meticorten, Sterapred), and others.This list is not complete and there may be other drugs that can interact with Levaquin/Tavanic (Levofloxacin) . Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



Generic Name Levofloxacin
Search Name Levaquin/ Tavanic Brand 500mg TAB
Supply Name TAVANIC
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage TAB
USA Brand Levaquin/ Tavanic
Manufacture Aventis Pharma India
Strength 500mg
Search Terms Levaquin/ Tavanic ,TAVANIC ,Levofloxacin
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to levofloxacin: oral solution, oral syrup, oral tablet

Other dosage forms:

intravenous solution
Along with its needed effects, levofloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levofloxacin:

More common
- Diarrhea

Rare
- Abdominal or stomach cramps or pain (severe)
- agitation
- blisters
- confusion
- diarrhea (watery and severe) which may also be bloody
- feeling that others can hear your thoughts or control your behavior
- fever
- pain, inflammation, or swelling in the calves of the legs, shoulders, or hands
- redness and swelling of the skin
- seeing, hearing, or feeling things that are not there
- sensation of burning on the skin
- severe mood or mental changes
- skin rash, itching, or redness
- trembling
- unusual behavior

Incidence not known
- Black, tarry stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- convulsions
- cough
- dark-colored urine
- difficulty with breathing
- difficulty with chewing, talking, or swallowing
- drooping eyelids
- fast or irregular heartbeat
- general body swelling
- hives
- hoarseness
- joint or muscle pain
- muscle cramps, spasms, pain, or stiffness
- peeling or loosening of the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe dizziness
- severe tiredness
- tightness in the chest
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- voice changes
- weakness in the arms, hands, legs, or feet

Some side effects of levofloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
- Abdominal or stomach pain or discomfort
- change in taste
- constipation
- dizziness
- drowsiness
- headache
- lightheadedness
- nausea
- nervousness
- trouble sleeping
- vaginal itching and discharge
- vomiting

Incidence not known
- Feeling faint
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- sweating
USUAL ADULT DOSE FOR NOSOCOMIAL PNEUMONIA

750 mg orally or IV every 24 hours for 7 to 14 days

Initial empiric treatment with broad-spectrum coverage according to the hospital's and/or ICU's antibiogram is recommended if multidrug-resistant organisms are suspected.

Duration: If the causative organism is not Pseudomonas aeruginosa, the duration of treatment should be as short as clinically possible (e.g., as little as 7 days) to reduce the risk of superinfections with resistant organisms.

USUAL ADULT DOSE FOR PNEUMONIA

Community-acquired pneumonia:
Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant S pneumoniae [MDRSP]), Haemophilus influenzae, H parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae: 500 mg orally or IV every 24 hours for 7 to 14 days

Due to S pneumoniae (excluding MDRSP), H influenzae, H parainfluenzae, M pneumoniae, or C pneumoniae: 750 mg orally or IV every 24 hours for 5 days

USUAL ADULT DOSE FOR SINUSITIS

Acute bacterial sinusitis: 500 mg orally or IV every 24 hours for 10 to 14 days or 750 mg orally or IV every 24 hours for 5 days

USUAL ADULT DOSE FOR BRONCHITIS

Acute bacterial exacerbation of chronic bronchitis: 500 mg orally or IV once a day for 7 days

USUAL ADULT DOSE FOR SKIN OR SOFT TISSUE INFECTION

Uncomplicated: 500 mg orally or IV once a day for 7 to 10 days
Complicated: 750 mg orally or IV once a day for 7 to 14 days

USUAL ADULT DOSE FOR PROSTATITIS

Chronic bacterial prostatitis: 500 mg orally or IV every 24 hours for 28 days

USUAL ADULT DOSE FOR URINARY TRACT INFECTION

Complicated:
Due to Enterococcus faecalis, Enterobacter cloacae, E coli, K pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa: 250 mg orally or IV once a day for 10 days
Due to E coli, K pneumoniae, or P mirabilis: 750 mg orally or IV once a day for 5 days

Uncomplicated: 250 mg orally or IV once a day for 3 days

USUAL ADULT DOSE FOR PYELONEPHRITIS

Acute:
Due to Escherichia coli: 250 mg orally or IV once a day for 10 days
Due to E coli (including cases with concurrent bacteremia): 750 mg orally or IV once a day for 5 days

USUAL ADULT DOSE FOR CYSTITIS

250 mg orally or IV once a day for 3 days

USUAL ADULT DOSE FOR ANTHRAX PROPHYLAXIS

Prophylaxis postexposure to inhalational Bacillus anthracis: 500 mg orally or IV once a day for 60 days after exposure

USUAL ADULT DOSE FOR PLAGUE

For treatment of plague (including pneumonic and septicemic plague) and prophylaxis for plague: 500 mg orally or IV once a day for 10 to 14 days

Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses (750 mg orally or IV once a day) can be used for treatment of plague if clinically indicated.

USUAL ADULT DOSE FOR PLAGUE PROPHYLAXIS

For treatment of plague (including pneumonic and septicemic plague) and prophylaxis for plague: 500 mg orally or IV once a day for 10 to 14 days

Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses (750 mg orally or IV once a day) can be used for treatment of plague if clinically indicated.

USUAL ADULT DOSE FOR INHALATION BACILLUS ANTHRACIS

(Not approved by FDA)

Mass casualty treatment: 500 mg orally or IV once a day for 60 days

The Working Group on Civilian Biodefense has suggested that, based on in vitro studies, levofloxacin could be used for treatment of inhalational anthrax if ciprofloxacin and doxycycline are not available. One or two additional antibiotics with activity against the causative organism (e.g., rifampin, vancomycin, penicillin, ampicillin, chloramphenicol, imipenem, clindamycin, or clarithromycin) should be added.

USUAL ADULT DOSE FOR TUBERCULOSIS - ACTIVE

(Not approved by FDA)

500 to 1000 mg orally or IV once a day

This regimen has been recommended by the Centers for Disease Control and Prevention (CDC), the Infectious Diseases Society of America, and American Thoracic Society.

May be given in combination with at least 3 other active drugs for treatment of multi-drug resistant TB, or when the patient is intolerant of first-line agents. AFB smear and culture should be monitored monthly.

Duration: Treatment for TB should generally continue for 18 to 24 months, or for 12 to 18 months after culture results are negative.

USUAL ADULT DOSE FOR NONGONOCOCCAL URETHRITIS

(Not approved by FDA)

CDC recommendations: 500 mg orally once a day for 7 days

Levofloxacin therapy is recommended as an alternative regimen. Single-dose azithromycin is a preferred regimen.

The patient's sexual partner(s) should also be evaluated/treated.

USUAL ADULT DOSE FOR CHLAMYDIA INFECTION

(Not approved by FDA)

CDC recommendations: 500 mg orally once a day for 7 days

Levofloxacin therapy is recommended as an alternative regimen. Single-dose azithromycin is a preferred regimen.

The patient's sexual partner(s) should also be evaluated/treated.

USUAL ADULT DOSE FOR PELVIC INFLAMMATORY DISEASE

(Not approved by FDA)

CDC recommendations:
Mild to moderately severe acute PID: 500 mg orally once a day for 14 days

Due to high rates of resistance, the CDC does not recommend fluoroquinolones for treatment of gonococcal infections in the United States. As a result, regimens that include a quinolone are not recommended for the treatment of PID. If parenteral cephalosporin therapy is not possible, oral levofloxacin (with or without oral metronidazole) can be considered if community prevalence and individual risk for gonorrhea are low. Prior to therapy, diagnostic tests for gonorrhea must be performed. If test results are positive for quinolone-resistant Neisseria gonorrhoeae and cephalosporin therapy is not possible, single-dose azithromycin should be added to this quinolone-based PID regimen.

If patients do not respond to oral therapy within 72 hours, they should be reevaluated and parenteral therapy should be initiated.

USUAL ADULT DOSE FOR EPIDIDYMITIS - SEXUALLY TRANSMITTED

(Not approved by FDA)

CDC recommendations: 500 mg orally once a day for 10 days

The patient's sexual partner(s) should also be evaluated/treated.

All patients should receive ceftriaxone plus doxycycline for initial (empiric) treatment. Additional therapy can include levofloxacin if testing determines acute epididymitis is not caused by gonorrhea or if the infection is most likely caused by enteric organisms.

Due to high rates of resistance, the CDC does not recommend fluoroquinolones for treatment of gonococcal infections in the United States. Ceftriaxone is the first-line agent recommended for the treatment of gonococcal infections in the United States. Antimicrobial susceptibility patterns should be monitored.

USUAL PEDIATRIC DOSE FOR ANTHRAX PROPHYLAXIS

Prophylaxis postexposure to inhalational B anthracis:
6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours for 60 days; not to exceed 250 mg per dose
50 kg or more: 500 mg orally or IV every 24 hours for 60 days

USUAL PEDIATRIC DOSE FOR PLAGUE

For treatment of plague (including pneumonic and septicemic plague) and prophylaxis for plague:
6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours for 10 to 14 days; not to exceed 250 mg per dose
50 kg or more: 500 mg orally or IV every 24 hours for 10 to 14 days

Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

USUAL PEDIATRIC DOSE FOR PLAGUE PROPHYLAXIS

For treatment of plague (including pneumonic and septicemic plague) and prophylaxis for plague:
6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours for 10 to 14 days; not to exceed 250 mg per dose
50 kg or more: 500 mg orally or IV every 24 hours for 10 to 14 days

Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

RENAL DOSE ADJUSTMENTS

Adults:
When dosage in normal renal function is 750 mg every 24 hours:
CrCl 20 to 49 mL/min: 750 mg orally or IV every 48 hours
CrCl 10 to 19 mL/min: 750 mg once, followed by 500 mg orally or IV every 48 hours

When dosage in normal renal function is 500 mg every 24 hours:
CrCl 20 to 49 mL/min: 500 mg once, followed by 250 mg orally or IV every 24 hours
CrCl 10 to 19 mL/min: 500 mg once, followed by 250 mg orally or IV every 48 hours

When dosage in normal renal function is 250 mg every 24 hours:
CrCl 20 to 49 mL/min: No adjustment recommended.
CrCl 10 to 19 mL/min: 250 mg orally or IV every 48 hours; however, if treating uncomplicated urinary tract infection, no adjustment is required

Tuberculosis:
CrCl less than 50 mL/min: 750 to 1000 mg orally or IV 3 times a week

Pediatrics: Data not available

LIVER DOSE ADJUSTMENTS

Data not available

PRECAUTIONS

Fluoroquinolones, including levofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in kidney, heart, or lung transplant recipients, and with the use of concomitant corticosteroids. Independent risk factors include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis; however, cases have been reported in patients with no known risk factors. Tendon rupture may occur during or up to several months after completion of therapy. Patients should be advised to discontinue levofloxacin, rest and avoid exercise, and contact their health care provider if they experience tendon pain, swelling, inflammation, or rupture.

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Patients should contact their healthcare provider at once if worsening muscle weakness or breathing problems develop. Levofloxacin should be avoided in patients with a known history of myasthenia gravis.

Some fluoroquinolones, including levofloxacin, have been associated with QT interval prolongation and infrequent cases of arrhythmia. Levofloxacin should be avoided in patients with known QT interval prolongation, patients with uncorrected hypokalemia, and in patients treated with Class IA or Class III antiarrhythmic agents. Patients should be advised to contact their physician if they experience syncope, irregular heartbeats, or palpitations.

Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported with fluoroquinolones, including levofloxacin. Fluoroquinolones may also cause central nervous system (CNS) stimulation, resulting in tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts. These reactions may occur following the first dose. Levofloxacin should be discontinued and appropriate measures taken if such CNS reactions occur. Levofloxacin should be used with caution in patients with a known or suspected CNS disorder or other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy, certain drug therapy, renal dysfunction). Patients should be advised to avoid driving or engaging in other tasks that require mental alertness and coordination until they know how the drug affects them.

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported, often following the first dose. The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support, and airway management as clinically indicated.

Severe hepatotoxicity, including acute hepatitis and fatal events, has been reported during postmarketing experience. Severe hepatotoxicity usually occurred within 14 days (most within 6 days) after starting levofloxacin and the majority of fatal hepatotoxicity cases occurred in patients 65 years or older. If the patient develops signs or symptoms of hepatitis (including fatigue, anorexia, nausea, vomiting, fever, weakness, jaundice, dark urine, liver tenderness), levofloxacin should be discontinued at once.

Levofloxacin has been associated with rare cases of sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, and weakness. To prevent development of an irreversible condition, levofloxacin should be discontinued if symptoms of neuropathy occur or if other alterations of sensation (including light touch, pain, temperature, position sense, and vibratory sensation) develop.

Patients should be advised to avoid excessive exposure to sunlight or artificial ultraviolet light during and for several days after treatment. The drug should be discontinued if photosensitivity or signs of phototoxicity (e.g., sunburn-like reaction, redness, oozing, burning, itching, rash, blistering, edema) occur.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following quinolone therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Crystalluria and cylindruria have been reported with quinolones. Patients should be well hydrated to prevent concentrated urine.

Renal, hepatic, and hematopoietic function should be monitored periodically during therapy.

Dosage adjustments are recommended for renally impaired patients. Caution and monitoring is recommended for elderly patients, who may be at a greater risk of adverse reactions due to declining renal function.

IV levofloxacin should be infused over 60 to 90 minutes, as rapid infusions may cause hypotension.

Careful blood glucose monitoring is recommended for patients with diabetes during levofloxacin therapy. Patients should discontinue levofloxacin, initiate appropriate therapy, and contact their physician if a hypoglycemic reaction occurs.

The safety of levofloxacin use for more than 28 days in adults and 14 days in pediatric patients has not been established. Prolonged treatment is only recommended when the benefit outweighs the risk.

Levofloxacin is not recommended for pediatric patients 6 months of age or older except for postexposure inhalation anthrax prophylaxis and for plague (treatment and prophylaxis). Greater frequencies of musculoskeletal disorders, such as arthralgia, arthritis, gait abnormality, and tendinopathy, have been reported in studies with pediatric patients. Safety and effectiveness have not been established in pediatric patients less than 6 months of age.

DIALYSIS

Hemodialysis or chronic ambulatory peritoneal dialysis:
Adults:
When dosage in normal renal function is 750 mg every 24 hours: 750 mg once, followed by 500 mg orally or IV every 48 hours
When dosage in normal renal function is 500 mg every 24 hours: 500 mg once, followed by 250 mg orally or IV every 48 hours
When dosage in normal renal function is 250 mg every 24 hours: Data not available

Tuberculosis: 750 to 1000 mg orally or IV 3 times a week; CAPD patients should be monitored to ensure doses are adequate

Continuous renal replacement therapy: Clearance may be significantly increased. Doses of 250 mg every 24 hours have been recommended. Monitor closely to ensure doses are adequate.

Pediatrics: Data not available

OTHER COMMENTS

The manufacturer's Medication Guide should be dispensed with each new and refill prescription.

Levofloxacin tablets may be taken without regard to meals. Levofloxacin oral solution should be taken 1 hour before or 2 hours after eating. Both the tablets and the oral solution should be administered at the same time each day. Patients should be advised to drink plenty of fluids.

Oral doses should be administered at least 2 hours before or 2 hours after iron-, zinc-, aluminum-, or magnesium-containing compounds (e.g., antacids, sucralfate, mineral supplements, buffered didanosine).

The 250 mg and 500 mg IV doses should be infused over at least 60 minutes and 750 mg doses should be infused over at least 90 minutes.

Sequential therapy (IV to oral) may be started at the physician's discretion.