Levobest

Levobest

levofloxacin

Manufacturer:

Zhejiang Medicine

Distributor:

Pharmabest
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Adult (2-18 yr) w/ mild, moderate or severe infections caused by susceptible strains of the designated microorganisms for acute bacterial sinusitis & exacerbation of chronic bronchitis, community-acquired & healthcare-associated pneumonia, complicated & uncomplicated (mild to moderate including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections) infections, complicated & uncomplicated UTIs, acute pyelonephritis, chronic bacterial prostatitis. To reduce incidence or progression of inhalational anthrax in adults & childn ≥6 mth following exposure to aerosolized Bacillus anthracis. Plague including pneumonic & septicemic plague due to Yersinia pestis & prophylaxis for plague in adult & childn ≥6 mth.
Dosage/Direction for Use
Adult Acute bacterial sinusitis, plague 500 mg for 10-14 days. Acute bacterial exacerbation of chronic bronchitis 500 mg for 7 days. Community-acquired pneumonia 500 mg for 10-14 days. Uncomplicated SSSI 500 mg for 7-10 days. Chronic bacterial prostatitis 500 mg for 28 days. Inhalation anthrax (post-exposure) 500 mg for 60 days. Childn ≥50 kg Inhalation anthrax (post-exposure), plague 500 mg once every 24 hr, <50 kg & ≥6 mth Inhalation anthrax (post-exposure) 8 mg/kg (not to exceed 250 mg/dose given every 12 hr) for 60 days, Plague 8 mg/kg (not to exceed 250 mg/dose given every 12 hr) for 10-14 days. Renal impairment CrCl ≥50 mL/min 500 mg every 24 hr, 20-49 mL/min Initially 500 mg then 250 mg every 24 hr, 10-19 mL/min & hemodialysis or chronic ambulatory peritoneal dialysis Initially 500 mg then 250 mg every 48 hr.
Administration
May be taken with or without food: Administer dose at least 2 hr before or after antacids (containing Ca, Mg or Al), sucralfate or metal cations (eg, Fe), multivit prep w/ Zn or didanosine.
Contraindications
Hypersensitivity to levofloxacin or other quinolones.
Special Precautions
Discontinue use at 1st appearance of skin rash or any other sign of hypersensitivity; if patient experiences pain, swelling, inflammation or rupture of a tendon, loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of skin or eyes, light-colored bowel movement or dark-colored urine, or symptoms of neuropathy; if photosensitization occurs. Not recommended in known or suspected MRSA infections. Not indicated in syphilis or gonorrhea. Avoid in patients w/ known history of myasthenia gravis; known prolongation of QT interval, uncorrected hypokalemia, significant bradycardia, cardiomyopathy or myocardial ischemia. Increased risk of tendinitis & tendon rupture. Clostridium difficile-associated diarrhea. Severe hepatotoxicity (including acute hepatitis & fatal events). Prolongation of QT interval on the ECG & infrequent cases of arrhythmia. Long-term or repeated use may result in overgrowth of non-susceptible organisms including fungi. Patients w/ known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or other risk factors (eg, certain drug therapy, renal impairment) that may predispose to seizures or lower seizure threshold; latent or actual defects in G6PD activity. Diabetic patients taking concomitant oral hypoglycemic agent &/or insulin. Avoid direct exposure to excessive sunlight or UV radiation during treatment. Periodically assess organs including renal, hepatic & hematopoietic during treatment. Avoid performing tasks requiring complete mental alertness eg, driving & operating machinery. Renal insufficiency. Pregnancy & lactation. Increased incidence of musculoskeletal disorders in childn. Elderly particularly those receiving concomitant corticosteroids.
Adverse Reactions
Moniliasis, fungal infection, edema, multiorgan failure, pyrexia, asthenia, pain, inj site reaction; chest pain, cardiac arrest, palpitation, ventricular tachycardia & arrhythmia, syncope, phlebitis, torsades de pointes, prolonged ECG QT, tachycardia, vasodilation, vasculitis, benign intracranial HTN, hypotension; insomnia, anxiety, agitation, confusion, depression, hallucination, nightmare, sleep disorder, abnormal dreaming, psychosis, paranoia, headache, dizziness, tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesia, abnormal gait, somnolence, peripheral neuropathy, abnormal EEG, dysphonia, exacerbation of myasthenia gravis, amnesia, pseudotumor cerebri, nervousness, peripheral sensory neuropathy & sensory motor neuropathy, dyskinesia, extrapyramidal disorder, isolated reports of suicide attempt or ideation & encephalopathy; rash, pruritus, urticaria, allergic reaction, angioedema, hypersensitivity & mucocutaneous reactions, bullous eruptions, hyperhidrosis; hyperglycemia, hypoglycemia, hypoglycemic coma, hyperkalemia, anorexia; nausea, diarrhea, constipation, abdominal pain, vomiting, dyspepsia, gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C. difficile colitis, flatulence; abnormal hepatic function, increased hepatic enzymes (ALT/AST/GGT), alkaline phosphatase & blood bilirubin, hepatic failure, hepatitis, jaundice, hepatic necrosis; anemia, thrombocytopenia, agranulocytosis, granulocytopenia, pancytopenia, aplastic & hemolytic anemia, leukopenia, eosinophilia, neutropenia, prolonged prothrombin time & INR; tendon disorder, arthralgia, myalgia, skeletal pain, tendon, ligament & muscle rupture, muscle injury, rhabdomyolysis, myositis, myalgia, arthritis, increased muscle enzymes (CPK); vaginitis, genital moniliasis, abnormal renal function, acute renal failure, interstitial nephritis, nephrosis, glomerulonephritis, increased blood creatinine; dyspnea, epistaxis, allergic pneumonitis, interstitial pneumonia, laryngeal edema, apnea, bronchospasm; uveitis, vision disturbance, reduced visual acuity, blurred vision, transient vision loss, scotoma, hypoacusis, tinnitus, hearing loss, impaired hearing, anosmia, parosmia, dysgeusia, ageusia.
Drug Interactions
Disturbances of blood glucose including hyperglycemia & hypoglycemia w/ antidiabetic agent. Potential pharmacologic interaction w/ antidepressants eg, fluoxetine, imipramine. GI absorption may be interfered w/ antacids (containing Ca, Mg or Al), metal cations (eg, Fe), multivit prep w/ Zn or any products containing any of these components. Increased risk of severe tendon disorders (eg, tendinitis, tendon rupture) particularly in elderly >60 yr w/ corticosteroids. Risk of CNS stimulation & convulsive seizures may be increased w/ NSAID. Reduced bioavailability w/ sucralfate. Possible increased AUC of tacrolimus. Prolonged elimination t½ & elevated serum levels of theophylline & subsequent increase in risk of theophylline-related adverse reactions. Enhanced effects of warfarin. May give false +ve urine screening results for opiates & false -ve results in bacteriological diagnosis of Tb.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Levobest FC tab 500 mg
Packing/Price
30's
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