Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

LEVOFLOXACIN

NFPA

PRODUCT USE

Broad- spectrum antibiotic with activity against many gram- positive and gram- negative
organisms. As with nalidixic acid and other 4- quinolone antibacterials, levofloxacin
appears to interfere with DNA gyrase (topoisomerase) activity. Cross- resistance amongst
the 4- quinolones occurs but cross- resistance with other antibacterials is rare.
Levofloxacin is primarily eliminated via glomerular filtration, thus necessitating a
dosage adjustment in renally compromised patients.

SYNONYMS

C18-H20-F-N3-O4.1/2H2O, "7H-pyrido[1, 2, 3-de]-1, 4-benzoxazine-6-carboxylic acid, 2, 3-
dihydro-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, hemihydrate, (S)-", "7H-
pyrido[1, 2, 3-de]-1, 4-benzoxazine-6-carboxylic acid, 2, 3-dihydro-9-fluoro-3-methyl-10-
(4-methyl-1-piperazinyl)-7-oxo-, hemihydrate, (S)-", DR3355, (-)-ofloxacin, (S)-
ofloxacin, Levaquin, RWJ-25213, "fluoroquinolone/ fluoroquinoline fluorinated quinolone/
quinoline", "antibiotic/ antibacterial/ antibiotic"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

None

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Although ingestion is not thought to produce harmful effects, the material may still be damaging to the health of the individual following ingestion, especially where pre-  existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, ingestion of insignificant quantities is not thought to be cause for concern.  Considered an unlikely route of entry in commercial/industrial environments.  Clinical signs of quinoline intoxication include lethargy, respiratory distress and prostration leading to coma.  Fluoroquinolones have been associated with kidney damage, effects after exposure to UV light, seizures, changes in blood sugar levels (especially in diabetics), and crystal formation in the urine. They can also cause disease in the joints. If quinolone antibiotics are used together with coumarin anti-coagulant drugs, there may be impaired healing in bleeds. Used at the same time as theophylline or caffeine, quinolones can cause stimulation of the heart and central nervous system which can be fatal, and simultaneous use of quinolones and cyclosporins increases the risk of kidney failure.  Exposure to this product can cause sensitization of skin under sunlight. The product can reach the skin via the bloodstream either if swallowed or ingested. Swelling and redness are common; blistering may also occur. The skin may become warm and itchy. There may also be discoloration. Phototoxicity is a non-allergic condition and severity depends on the concentration of the offending chemical and the amount of radiation of particular wavelengths, usually in the UV spectrum. Inflammation develops on uncovered areas such as the hands and face; covered areas are usually spared. This is usually more like sunburn than an eczema. Coal tar products often cause phototoxic reactions. Phototoxic compounds may show their nature either by generating free radicals or reacting directly with target molecules under UV light.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  Phototoxic agents such as sulfonamides can cause inflammation of the conjunctiva and cornea, and clouding.  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  

INHALED

  Inhalation may produce health damage*.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of the material, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are usually by skin contact/absorption and inhalation of generated dust.  No human exposure data available. For this reason health effects described are based on experience with chemically related materials.  As with any chemical product, contact with unprotected bare skin; inhalation of vapor, mist or dust in work place atmosphere; or ingestion in any form, should be avoided by observing good occupational work practice.