Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Tafluprost
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
S01EE05
0.015mg/ml
SOLUTION, STERILE
Tafluprost 0.015mg/ml
OPHTHALMIC
Prescription Only
Santen Pharmaceutical Co., Ltd. Shiga Plant
ACTIVE
2010-10-07
参天製薬 756731 MU_タフロタン点眼液(シンガポール)添付文書 2860-02〈06〉オモテ(21/09/03) 420×120 1° コン 大光印刷株式会社 Composition Taflotan ophthalmic solution 0.0015% is a clear, colorless, sterile aqueous ophthalmic solution. Each mL contains 15μg of tafluprost. It also contains Polysorbate 80, concentrated glycerin, disodium edetate hydrate, sodium dihydrogen phosphate dihydrate, benzalkonium chloride and pH adjuster (sodium hydroxide, hydrochloric acid) as additives. Its pH is 5.7 - 6.3 and its osmolar ratio is 1.0 - 1.1. Indications Reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Dosage and Administration Instill 1 drop in the affected eye(s) once daily.Do not use more than once daily because more frequent administration may lessen the IOP-lowering effect. Pharmacology 1.Intraocular pressure (IOP) lowering effect Ocular administration of tafluprost ophthalmic solutions ranged from 0.00002% to 0.005% in a single dose to monkeys showed the IOP lowering effect in a concentration-dependent manner. The effect was statistically significant in the groups of the concentration of 0.0005% and higher, compared with the vehicle group. In a repeated dose study in monkeys of tafluprost ophthalmic solutions ranged from 0.001% to 0.005% once daily for 5 days, IOP lowering effect at every concentration was stable and did not attenuate during the administration period. 2.Mechanism of action Tafluprost acid form, an active metabolite, showed high affinity for the prostanoid FP receptor (Ki=0.40 nM). Aqueous humor dynamics in monkeys was evaluated using fluorophotometry, two-level constant pressure perfusion and 125 I- 131 I labelled albumin perfusion methods following the repeated administration of 0.005% tafluprost ophthalmic solution once daily for 3 to 5 days. Uveoscleral outflow significantly increased without any change in aqueous production. 3.Effect on ocular blood flow (1) A repeated installati Soma hati kamili