| GHS 分類 | DangerH302 (85.2%): Harmful if swallowed [Warning Acute toxicity, oral]P203, P233, P260, P261, P264, P270, P271, P272, P280, P284, P301+P317, P302+P352, P304+P340, P317, P318, P321, P330, P333+P317, P342+P316, P362+P364, P403, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 61 reports by companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.This chemical does not meet GHS hazard criteria for 23.1% (3 of 13) of reports. |
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| 火災の可能性 | This material is assumed to be combustible. |
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| FDA 要件 | The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including ofloxacin, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. |
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| Toxic Combustion Products | Emits toxic fumes under fire conditions. |
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| Hazard Classes and Categories | Acute Tox. 4 (85.2%)Acute Tox. 4 (30.8%) |
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| 消火手順 | Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials. |
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| 保管条件 | Ofloxacin ophthalmic solution and otic solution should be stored at 15-30 °C.Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. |
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| 清掃方法 | Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labelled container for disposal. Wash spill site. |
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| 処分方法 | SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.SRP: At the time of review, regulatory criteria for small quantity disposal are subject to significant revision, however, household quantities of waste pharmaceuticals may be managed as follows: Mix with wet cat litter or coffee grounds, double bag in plastic, discard in trash. |
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| Preventive Measures | Engineering controls such as exhaust ventilation are recommended.As a general rule, when handling USP Reference Standards avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker. |
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| Personal Protective Equipment (PPE) | Respiratory Protection: Use a NIOSH-approved respirator, if it is determined to be necessary by an industrial hygiene survey involving air monitoring. In the event that a respirator is not required, an approved dust mask should be used. Gloves: Chemically compatible. Eye Protection: Safety glasses or goggles. Protective Clothing: Protect exposed skin. |
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| Treatment | In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. (L1009) |
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| 相互作用 | Concomitant administration of some fluoroquinolone anti-infectives (e.g., ciprofloxacin, norfloxacin, ofloxacin) in patients receiving theophylline has resulted in higher and prolonged serum theophylline concentrations and may increase the risk of theophylline-related adverse effects. The extent of this interaction varies considerably among the commercially available fluoroquinolonesthe effect is less pronounced with norfloxacin or ofloxacin than with ciprofloxacin. While it has been suggested that the 4-oxo metabolites of these quinolones may inhibit metabolism of theophylline in the liver, and there is some evidence that the degree to which the various quinolones are metabolized to 4-oxo metabolites may correlate with the extent of alteration in theophylline pharmacokinetics when the drugs are administered concomitantly, the potential contribution, if any, of the 4-oxo metabolites to this interaction has not been fully elucidated. In addition, other evidence indicates that, while formation of these metabolites may correlate with inhibition of theophylline metabolism, the 4-oxo metabolites themselves are not responsible for the observed effect.Studies using other fluoroquinolones (e.g., ciprofloxacin) indicate that concomitant administration of probenecid interferes with renal tubular secretion of the drugs. The effect of concomitant administration of probenecid and ofloxacin has not been studied to date.Concomitant administration of a fluoroquinolone (i.e., ofloxacin) and fenbufen (a nonsteroidal anti-inflammatory agent (NSAIA)) reportedly resulted in an increased incidence of seizures. Concomitant use of a fluoroquinolone with an NSAIA could increase the risk of CNS stimulation (e.g., seizures). Animal studies using other fluoroquinolones suggest that the risk may vary depending on the specific NSAIA.Oral multivitamin and mineral supplements containing divalent or trivalent cations such as iron or zinc may decrease oral absorption of ofloxacin resulting in decreased serum concentrations of the quinolonetherefore, these multivitamins and/or mineral supplements should not be ingested concomitantly with or within 2 hours of an ofloxacin dose. In a crossover study, concomitant administration of a single dose of oral ferrous sulfate complex and ofloxacin decreased the AUC of the anti-infective by 36%.For more Interactions (Complete) data for Ofloxacin (19 total), please visit the HSDB record page. |
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| 健康影響 | Irreversible peripheral neuropathy, central nervous system toxicity, cardiovascular toxicity, tendon / articular toxicity, and hepatic toxicity. Toxic epidermal necrolysis, coagulation abnormalities and pancytopenia are other possible adverse effect of levofloxacin. Administration of commercial levofloxin (Levaquin), increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon (L1009, L1017). |
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| Hepatotoxicity | Mild elevations in ALT and alkaline phosphatase levels occur in 1 to 2% of patients on ofloxacin. These abnormalities are generally mild, asymptomatic and transient, resolving even with continuation of therapy. Ofloxacin has also been linked to rare but occasionally severe and even fatal cases of acute liver injury. The time to onset is typically short (2 days to 2 weeks) and the presentation is often abrupt with nausea, fatigue, abdominal pain and jaundice. The pattern of serum enzyme elevations can be either hepatocellular or cholestatic, cases with the shorter times to onset usually being more hepatocellular with markedly elevated ALT levels, and occasionally with rapid worsening of prothrombin time and signs of hepatic failure. The onset of illness may occur a few days after the medication is stopped. Cases with a cholestatic pattern of enzymes may run a prolonged course but are usually self-limiting. Many (but not all) cases have had allergic manifestations with fever, rash and eosinophilia. Autoantibodies are usually not present. The hepatotoxicity of ofloxacin is similar to that of other fluoroquinolones and appears to represent a class effect. |
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| 生態毒性値 | EC50Species: Microcystis aeruginosa (Blue-Green Algae)Conditions: freshwater, static, 20 °CConcentration: 21 ug/L for 5 days (95% confidence interval: 18-24 ug/L)Effect: population, decreased chlorophyll A concentration /99% purity formulation/Species: Pseudokirchneriella subcapitata (Green Algae)Concentration: 12100 ug/L for 3 days (95% confidence interval: 10400-13700 ug/L)Species: Lemna minor (Duckweed)Conditions: freshwater, renewal, 25 °CConcentration: 126 ug/L for 7 days (95% confidence interval: 52-201 ug/L)Effect: population, decreased abundance (counted number of fronds) /99% purity formulation/ |
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| 環境中動態 | TERRESTRIAL FATE: Based on a classification scheme(1), a Koc value of 44,143(2) indicates that ofloxacin is expected to be immobile in soil(SRC). Ofloxacin is an amphoteric compound with pKa values of 5.97 for the carboxylic acid group and 8.28 for the nitrogen on the piperazinyl ring(3)at pHs greater than 5.97, the acid will be primarily dissociated and at pHs less than 8.28, the nitrogen will be primarily protonated(SRC)therefore, ofloxacin will have an ionic charge at any environmental pH. Volatilization from moist soil is not expected because the compound exists as an ion and ions do not volatilize. Ofloxacin is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 9.8X10-13 mm Hg at 25 °C(SRC), determined from a fragment constant method(4). A 0% of theoretical BOD using activated sludge in the Closed Bottle test(5) suggests that biodegradation is not an important environmental fate process in soil(SRC).AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 44,143(2) indicates that ofloxacin is expected to adsorb to suspended solids and sediment(SRC). Ofloxacin is an amphoteric compound with pKa values of 5.97 for the carboxylic acid group and 8.28 for the nitrogen on the piperazinyl ring(3)therefore, volatilization from water surfaces is not expected to be an important fate process. According to a classification scheme(4), an estimated BCF of 3(SRC), from its log Kow of -0.39(5) and a regression-derived equation(6), suggests the potential for bioconcentration in aquatic organisms is low(SRC). A 0% of theoretical BOD using activated sludge in the Closed Bottle test(7) suggests that biodegradation is not an important environmental fate process in water(SRC).ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), ofloxacin, which has an estimated vapor pressure of 9.8X10-13 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase ofloxacin may be removed from the air by wet or dry deposition(SRC). The quantum yield for the direct photolysis of ofloxacin in bi-distilled water at pH 5 is 4.29X10-5 Mol/E(4), suggesting that ofloxacin may be susceptible to direct photolysis by sunlight(SRC). |
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| 有害作用 | Tendinopathy: The most characteristic adverse effect of ofloxacin treatment and other fluoroquinolone treatments is tendinopathy, typically presenting as pain or swelling along a tendon’s path. Such injury has been observed both during drug administration and several months after. In addition, there is a particularly high risk of tendon rupture in patients receiving corticosteroid therapy or engaging in strenuous physical activity with concurrent ofloxacin administration. This injury primarily affects the Achilles tendon and necessitates surgical repair. |
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| 暴露経路 | Ingestioninjectionskin contact (L1017).
Absorption of ofloxacin after single or multiple doses of 200 to 400 mg is predictable, and the amount of drug absorbed increases proportionately with the dose. |
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| 毒性の概要 | Information on toxicity with ofloxacin is limited. One case report of accidental overdosage has been described in which an adult female received 3 grams of ofloxacin intravenously over 45 minutes. The patient developed dizziness, hot and cold flushes, drowsiness, nausea, slurring of speech, and mild to moderate disorientation during the infusion. Laboratory testing detected no clinically significant changes in routine parameters in this patient.Levofloxacin inhibits bacterial type II topoisomerases, topoisomerase IV and DNA gyrase. Levofloxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealingDNA replication and transcription is inhibited. |
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| 生態毒性抜粋 | /AQUATIC SPECIES/ Toxicity tests were performed with seven fluoroquinolone antibiotics, ciprofloxacin, lomefloxacin, ofloxacin, levofloxacin, clinafloxacin, enrofloxacin, and flumequine, on five aquatic organisms. Overall toxicity values ranged from 7.9 to 23,000 ug/L. The cyanobacterium Microcystis aeruginosa was the most sensitive organism (5-day growth and reproduction, effective concentrations [EC50s] ranging from 7.9 to 1,960 ug/L and a median of 49 ug/L), followed by duckweed (Lemna minor, 7-day reproduction, EC50 values ranged from 53 to 2,470 ug/L with a median of 106 ug/L) and the green alga Pseudokirchneriella subcapitata (3-day growth and reproduction, EC50 values ranged from 1,100 to 22,700 ug/L with a median 7,400 ug/L). Results from tests with the crustacean Daphnia magna (48-hr survival) and fathead minnow (Pimephales promelas, 7-day early life stage survival and growth) showed limited toxicity with no-observed-effect concentrations at or near 10 mg/L. Fish dry weights obtained in the ciprofloxacin, levofloxacin, and ofloxacin treatments (10 mg/L) were significantly higher than in control fish. The hazard of adverse effects occurring to the tested organisms in the environment was quantified by using hazard quotients. An estimated environmental concentration of 1 ug/L was chosen based on measured environmental concentrations previously reported in surface waterat this level, only M. aeruginosa may be at risk in surface water. However, the selective toxicity of these compounds may have implications for aquatic community structure. |
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| Signs and Symptoms | Side effects include disorientation, dizziness, drowsiness, hot and cold flashes, nausea, slurring of speech, swelling and numbness in the face. |
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| Effluent Concentrations | Ofloxacin was detected in treated wastewater effluents from 8 treatment plants in 5 Canadian cities at a median concentration of 0.094 ug/L (maximum of 0.506 ug/L)sampling was conducted in 2002(1). Ofloxacin was reported in sewage treatment plant effluents at concentrations of 0.33-0.51, 0.46, 0.29-0.58, 0.12, and 0.33-0.58 ug/L sampled in France, Greece, Italy, Sweden, and Germany and Switzerland, respectively(2). Ofloxacin was not detected at higher than the detection limit of 0.1 mg/kg in sewage water and sludge grab samples from a treatment plant in Umea, Sweden, sampled for three consecutive days in November and December, 2004(3). Ofloxacin was detected at a concentration of 55,000 ng/L in undiluted effluent from the Patancheru Enviro Tech Ltd. Treatment plant, Patancheru, Indialimit of detection = 10 ng/L(4). Ofloxacin loads ranged from 83-614 mg/day/1000 inhabitants (influent) to 26-268 mg/day/1000 inhabitants (effluent) in a study 6 sewage treatment plants from different regions of Italy(5). |
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| 水環境危害等級（WGK） | 2 |
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| RTECS 番号 | UU8815500 |
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| 安全措置（S） | 22-24/25 |
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