Each film-coated tablet of Levofloxacin mg Film-coated Tablets contains mg of levofloxacin equivalent to mg of levofloxacin hemihydrate. Name: Levofloxacin hemihydrate; Drug Entry: Levofloxacin. A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling. Find patient medical information for Levofloxacin Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
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The tablets may be taken during meals or between meals. Tendon disorders see sections 4. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition. More research is needed to determine the best dose and length of treatment.
Duration of treatment according to severity. Arzneimittelwirkungen in German 8 ed. For this reason, it is considered a “respiratory fluoroquinolone” along with more recently developed fluoroquinolones such as moxifloxacin and gemifloxacin.
Qualitative and quantitative composition 3. The tablet can be divided into equal doses. Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. Levofloxacin did not induce gene mutations in bacterial or mammalian cells but did induce chromosome aberrations in Chinese hamster lung cells in vitro. Levofloxacin and other fluoroquinolones have also been widely used for the treatment of uncomplicated community-acquired respiratory and urinary tract infections, indications for which major medical societies generally recommend the use of older, narrower spectrum drugs to avoid fluoroquinolone resistance development.
Levofloxacin is used to treat infections including: Common side effects include nauseadiarrheaand trouble sleeping. Continue typing to refine. Phlebitis Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Bronchospasm Pneumonitis allergic Gastro- intestinal disorders Diarrhoea Vomiting Nausea Abdominal pain Dyspepsia Flatulence Constipation Diarrhoea — haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis see section 4.
In one study,   juvenile patients age 6 months to 16 years treated with levofloxacin as part of three efficacy trials were followed up to assess all musculoskeletal events occurring up to 12 months post-treatment.
Levofloxacin – Wikipedia
FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection”.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, hemihyrate dose toxicity, carcinogenic potential and toxicity to reproduction and development.
With decreasing renal function, renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below: CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience.
In the United States levofloxacin is approved for the treatment of anthrax and plague in children over six months of age. Angioedema Hypersensitivity see section 4.
Levofloxacin was approved for medical use in the United States in Psychotic reactions Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. Unlike ciprofloxacin, levofloxacin does not appear to deactivate the drug metabolizing enzyme CYP1A2. No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function see section 4. To view the changes to a medicine you must sign up and log in.
Other undesirable effects which have been associated with fluoroquinolone administration include:.
Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant. Excipient with known effect: Levofloxacin is marketed by Sanofi-Aventis levofloxzcin a license agreement signed with Daiichi in under the trade name “Tavanic”.
Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis. The most common adverse reactions leading to discontinuation were gastrointestinal, including nausea, vomiting, and constipation.
Levofloxacin mg Film-coated Tablets is contraindicated in breast-feeding women.
If superinfection occurs during therapy, appropriate measures should be taken. Levofloxacin acts as a bactericide.
No special requirements Any unused medicinal product hemihydrte waste material should be disposed of in accordance with local requirements. Absorption Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within h.
Archived PDF from the original on 18 October Rhabdomyolysis Tendon rupture e. Drugs known to prolong QT interval Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval e.
J Hemigydrate Aesthet Dermatol.