CCL Pharma


Concise Prescribing Info
Levofloxacin hemihydrate
Tab: Infections caused by bacteria susceptible to levofloxacin: pneumonia, chronic bronchitis, diffuse panbronchiolitis, bronchiectasis w/ infection, secondary infections in chronic resp disease; laryngopharyngitis, tonsillitis (peritonsillitis, peritonsillar abscess), acute bronchitis; pyelonephritis, cystitis, prostatitis, epididymitis, gonococcal urethritis, non-gonococcal urethritis; intrauterine infections, cervicitis, uterine adnexitis, bartholinitis; folliculitis (including acne pustulosa), furuncle, furunculosis, carbuncle, impetigo contagiosa, hydradenitis, acne conglabata, infectious atheroma, periproctic abscess; mastitis, secondary infections in traumatic & operative wounds, burns; cholecystitis, cholangitis; otitis externa & media, sinusitis, suppurative sialadenitis; blepharitis, hordeolum, dacryocystitis, conjunctivitis, tarsadenitis; bacterial dysentery, infectious & Salmonella enteritis, cholera; periodontitis, pericoronitis, gnathitis. Infusion: Bacterial infections in adults caused by levofloxacin-sensitive bacteria: community acquired pneumonia, complicated UTI, skin & soft tissue infections.
Dosage/Direction for Use
Tab Acute bacterial exacerbation of chronic bronchitis 250 mg bd or 500 mg once daily for 7 days. Community-acquired pneumonia 250 mg bd or 500 mg once daily for 7-14 days. Acute maxillary sinusitis 250 mg bd or 500 mg once daily for 10-14 days. Complicated UTI, acute pyelonephritis 250 mg for 10 days. Uncomplicated skin & soft tissue infection 250 mg bd or 500 mg once daily for 7-10 days. Infusion Administer by slow IV infusion. Pneumonia 500 mg once daily or bd. UTI 250 mg once daily. Skin & soft tissue infection 500 mg bd.
May be taken with or without food: Swallow whole w/ sufficient amount of liqd, do not crush. May be divided along the score-line. Take 2 hr before iron salts, antacids & sucralfate administration.
Hypersensitivity to levofloxacin, ofloxacin or any other quinolones. Childn & adolescents. Infusion: Patients w/ epilepsy; history of tendon disorders related to fluoroquinolones. Suspected pregnancy or pregnancy & lactation.
Special Precautions
Elderly. Tab: Patients w/ severe renal disorders; history of convulsive disorders. Infusion: Discontinue infusion in case of conspicuous drop in BP; severe, persistent &/or bloody diarrhoea; suspected tendinitis. Increased risk of convulsions in patients w/ history of stroke or severe brain injury; concomitant treatment w/ fenbufen or comparable non-steroidal antiphlogistics or theophylline. Avoid exposure to strong sunlight or artificial UV rays. Patients w/ G6PD deficiency. Combination w/ alcohol. May impair ability to drive a car or operate machinery especially in combination w/ alcohol.
Adverse Reactions
Tab: Increased BUN; increased SGOT, SGPT, ALP or γ-GTP; rhabdomyolysis w/ rapid deterioration of renal function. Infusion: GI symptoms; headache, dizziness, sleep disturbances, unsteady gait & tremor, numbness & tingling in the limbs; visual & auditory disturbances, hallucinations, convulsions, psychotic reactions; changes in blood picture, hepatitis, transient increase in liver enzymes &/or bilirubin, serum creatinine; local irritation, pain & reddening at inj site, phlebitis; hypersensitivity reactions; Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme; photosensitivity reactions, fever, allergy, pneumonitis, angioedema, hypotension, anaphylactic-like shock; tendon rupture; muscular weakness; rhabdomyolysis; hypoglycemia; asthenia, fungal overgrowth & proliferation of other resistant microorganism.
Drug Interactions
Tab: May rarely cause convulsions w/ NSAIDs of phenylacetic/propionic acid derivative eg, fenbufen. Al or Mg-containing antacids & Fe-containing drugs may interfere w/ levofloxacin absorption. Infusion: Lowering of cerebral seizure threshold w/ theophylline; fenbufen or NSAIDs. Reduced renal clearance w/ cimetidine & probenecid. Increased t1/2 of cyclosporine.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Levocil infusion 500 mg/100 mL
Levocil tab 250 mg
5 × 10's
Levocil tab 500 mg
1 × 10's
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