COSOPT OPHTHALMIC SOLUTION

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

DORZOLAMIDE HCl; TIMOLOL MALEATE

Dostupné s:

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

ATC kód:

S01ED51

Dávkování:

2.00%

Léková forma:

SOLUTION

Složení:

DORZOLAMIDE HCl 2%; TIMOLOL MALEATE 0.5%

Podání:

OPHTHALMIC

Druh předpisu:

Prescription Only

Výrobce:

Santen Pharmaceutical Co., Ltd. Noto Plant

Stav Autorizace:

ACTIVE

Datum autorizace:

2001-08-22

Informace pro uživatele

PACKAGE INSERT
Sterile Ophthalmic Solution
(dorzolamide hydrochloride and timolol maleate ophthalmic solution)
I. THERAPEUTIC CLASS
COSOPT
®
Ophthalmic Solution (dorzolamide hydrochloride and timolol maleate) is
the first combination
of a topical carbonic anhydrase inhibitor and a topical
beta-adrenergic receptor blocking agent.
II. CLINICAL PHARMACOLOGY
IIa. Mechanism of Action
COSOPT is comprised of two components: dorzolamide hydrochloride and
timolol maleate. Each of
these two components decreases elevated intraocular pressure by
reducing aqueous humor secretion,
but does so by a different mechanism of action.
Dorzolamide hydrochloride is a potent inhibitor of human carbonic
anhydrase II. Inhibition of carbonic
anhydrase in the ciliary processes of the eye decreases aqueous humor
secretion, presumably by
slowing the formation of bicarbonate ions with subsequent reduction in
sodium and fluid transport.
Timolol maleate is a nonselective beta-adrenergic receptor blocking
agent that does not have significant
intrinsic sympathomimetic, direct myocardial depressant, or local
anesthetic (membrane-stabilizing)
activity. The combined effect of these two agents results in
additional intraocular pressure reduction
compared to either component administered alone.
Following topical administration, COSOPT reduces elevated intraocular
pressure, whether or not
associated with glaucoma. Elevated intraocular pressure is a major
risk factor in the pathogenesis of
optic nerve damage and glaucomatous visual field loss. The higher the
level of intraocular pressure, the
greater the likelihood of glaucomatous visual field loss and optic
nerve damage. COSOPT reduces
intraocular pressure without the common side effects of miotics such
as night blindness,
accommodative spasm and pupillary constriction.
IIb. Pharmacokinetics / Pharmacodynamics
Dorzolamide Hydrochloride
Unlike oral carbonic anhydrase inhibitors, topical administration of
dorzolamide hydrochloride allows for
the drug to exert its effects directly in the eye at substantia

Charakteristika produktu

PACKAGE INSERT
Sterile Ophthalmic Solution
(dorzolamide hydrochloride and timolol maleate ophthalmic solution)
I. THERAPEUTIC CLASS
COSOPT
®
Ophthalmic Solution (dorzolamide hydrochloride and timolol maleate) is
the first combination
of a topical carbonic anhydrase inhibitor and a topical
beta-adrenergic receptor blocking agent.
II. CLINICAL PHARMACOLOGY
IIa. Mechanism of Action
COSOPT is comprised of two components: dorzolamide hydrochloride and
timolol maleate. Each of
these two components decreases elevated intraocular pressure by
reducing aqueous humor secretion,
but does so by a different mechanism of action.
Dorzolamide hydrochloride is a potent inhibitor of human carbonic
anhydrase II. Inhibition of carbonic
anhydrase in the ciliary processes of the eye decreases aqueous humor
secretion, presumably by
slowing the formation of bicarbonate ions with subsequent reduction in
sodium and fluid transport.
Timolol maleate is a nonselective beta-adrenergic receptor blocking
agent that does not have significant
intrinsic sympathomimetic, direct myocardial depressant, or local
anesthetic (membrane-stabilizing)
activity. The combined effect of these two agents results in
additional intraocular pressure reduction
compared to either component administered alone.
Following topical administration, COSOPT reduces elevated intraocular
pressure, whether or not
associated with glaucoma. Elevated intraocular pressure is a major
risk factor in the pathogenesis of
optic nerve damage and glaucomatous visual field loss. The higher the
level of intraocular pressure, the
greater the likelihood of glaucomatous visual field loss and optic
nerve damage. COSOPT reduces
intraocular pressure without the common side effects of miotics such
as night blindness,
accommodative spasm and pupillary constriction.
IIb. Pharmacokinetics / Pharmacodynamics
Dorzolamide Hydrochloride
Unlike oral carbonic anhydrase inhibitors, topical administration of
dorzolamide hydrochloride allows for
the drug to exert its effects directly in the eye at substantia