Blood Level of Tacrolimus in Patients with Severe Allergic Conjunctivitis Treated by 0.1% Tacrolimus Ophthalmic Suspension
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- Ebihara Nobuyuki
- Department of Ophthalmology, Juntendo University School of Medicine
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- Ohashi Yuichi
- Department of Ophthalmology, Ehime University School of Medicine
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- Fujishima Hiroshi
- Department of Ophthalmology, Tsurumi University School of Dental Medicine
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- Fukushima Atsuki
- Department of Ophthalmology, Kochi Medical School
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- Nakagawa Yayoi
- Nakagawa Eye Clinic
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- Namba Kenichi
- Department of Ophthalmology and Visual Science, Hokkaido University Graduate School of Medicine
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- Okamoto Shigeki
- Okamoto Eye Clinic
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- Shoji Jun
- Department of Ophthalmology, Division of Visual Sciences, Nihon University School of Medicine
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- Takamura Etsuko
- Department of Ophthalmology, Tokyo Women’s Medical University School of Medicine
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- Uchio Eiichi
- Department of Ophthalmology, Fukuoka University, School of Medicine
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- Miyazaki Dai
- Department of Ophthalmology, Tottori University, School of Medicine
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Abstract
Background: To estimate the efficacy and safety of 0.1% tacrolimus ophthalmic suspension based on the blood level of tacrolimus in patients with severe allergic conjunctivitis.<br> Methods: Fifty-two patients in whom topical anti-allergic agents had been ineffective were treated with 0.1% tacrolimus ophthalmic suspension twice daily for 12 weeks. Adverse drug reactions were monitored, as well as ocular symptoms and signs. The blood concentration of tacrolimus was measured before the initiation of treatment and 4 and 12 weeks later.<br> Results: About 75% of the patients without concomitant using of tacrolimus ointment had blood levels of tacrolimus below the detection limit of the assay (0.5ng/mL). On the other hand, 71% (week 4) and 57% (week 12) of patients with concomitant using of tacrolimus ointment had blood levels above the detection limit of the assay. However, the maximum blood concentration was less than 2ng/mL. Adverse drug reactions occurred in 16 patients. These were disorders of the eye such as warmness, irritation, and a burning sensation. However, all of the patients could continue treatment with tacrolimus for 12 weeks. There were no serious adverse events such as increased intraocular pressure or ocular infection during the study. All symptoms and signs improved over time.<br> Conclusions: The good safety profile of 0.1% tacrolimus ophthalmic suspension based on the low blood concentration of tacrolimus, coupled with demonstrated efficacy, make it an important tool for treating severe allergic conjunctivitis.<br>
Journal
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- Allergology International
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Allergology International 61 (2), 275-282, 2012
Japanese Society of Allergology