Taflotan Ophthalmic Solution 0.0015%

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Tafluprost

Disponible des:

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Codi ATC:

S01EE05

Dosis:

0.015mg/ml

formulario farmacéutico:

SOLUTION, STERILE

Composición:

Tafluprost 0.015mg/ml

Vía de administración:

OPHTHALMIC

tipo de receta:

Prescription Only

Fabricat per:

Santen Pharmaceutical Co., Ltd. Shiga Plant

Estat d'Autorització:

ACTIVE

Data d'autorització:

2010-10-07

Fitxa tècnica

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