部分中文IQUIX处方资料(仅供参考)
The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of levofloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. These organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of corneal ulcer. Levofloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 µg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens:
INDICATIONS AND USAGE IQUIX® solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
CONTRAINDICATIONS IQUIX® solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. WARNINGS NOT FOR INJECTION. IQUIX® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. PRECAUTIONS GeneralAs with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, induding fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer. Information for PatientsAvoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction. Drug InteractionsSpecific drug interaction studies have not been conducted with IQUIX®. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly. Carcinogenesis, Mutagenesis, Impairment of FertilityIn a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day) was 100 times the highest recommended human ophthalmic dose. Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, corresponding to 400 times the highest recommended human ophthalmic dose. Pregnancy Teratogenic Effects Pregnancy Category C Levofloxacin at oral doses of 810 mg/kg/day in rats, which corresponds to approximately 1000 times the highest recommended human ophthalmic dose, caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, which corresponds to approximately 60 times the highest recommended maximum human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, corresponding to approximately 30 times the highest recommended human ophthalmic dose. There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing MothersLevofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when IQUIX® is administered to a nursing mother. Pediatric UseSafety and effectiveness in children below the age of six years have not been established. Oral administration of systemic quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints. Geriatric UseNo overall differences in safety or effectiveness have been observed between elderly and other adult patients. ADVERSE REACTIONS The most frequently reported adverse events in the overall study population were headache and a taste disturbance following instillation. These events occurred in approximately 8–10% of patients. Adverse events occurring in approximately 1–2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, corneal ulcer, diplopia, floaters, hyperemia, lid edema, and lid erythema. DOSAGE AND ADMINISTRATION Days 1 through 3Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completionInstill one to two drops in the affected eye(s) every 1 to 4 hours while awake. HOW SUPPLIED IQUIX® (levofloxacin ophthalmic solution) 1.5% is supplied in a white, low density polyethylene bottle with a controlled dropper tip and a tan, high density polyethylene cap in the following size: 5 mL fill in 5 cc container– NDC 68669-145-05 StorageStore at 15° – 25°C (59°– 77°F). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=067EA8EC-99A3-4A0B-9116-4FFD6160B24B --------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: IQUIX 1.5% EYE DROPS 5mls/bottle 原产地英文药品名: LEVOFLOXACIN 中文参考商品译名: IQUIX 1.5%滴眼液 5毫升/瓶 中文参考药品译名: 左氧氟沙星 中文参考化合物名称: (一)一(S)一9一氟一2,3一二氢一3一甲基一10一(4一甲基一1-哌嗪基一7一氧代一7H一吡啶并[1,2,3一de]一1,4一苯并恶嗪一6一羧酸半水合物 生产厂家中文参考译名: 参天制药 生产厂家英文名: SANTEN |