DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION STERILE OPHTHALMIC SOLUTION

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)

Mevcut itibaren:

ALVOGEN INC.

INN (International Adı):

DORZOLAMIDE HYDROCHLORIDE

Kompozisyon:

DORZOLAMIDE 22.3 mg in 1 mL

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION STERILE OPHTHALMIC SOLUTION- DORZOLAMIDE HYDROCHLORIDE-TIMOLOL
MALEATE OPHTHALMIC
SOLUTION SOLUTION
ALVOGEN INC.
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DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION
STERILE OPHTHALMIC SOLUTION
DESCRIPTION
Dorzolamide hydrochloride – timolol maleate (dorzolamide
hydrochloride-timolol maleate ophthalmic
solution) is the combination of a topical carbonic anhydrase inhibitor
and a topical beta- adrenergic
receptor blocking agent.
Dorzolamide hydrochloride is described chemically as:
(4S-trans)-4-(ethylamino)-5,6-dihydro-6-
methyl-4H-thieno[2,3-b]thiopyran]thiopyran-2-sulfonamide 7,7-dioxide
monohydrochloride.
Dorzolamide hydrochloride is optically active. The specic rotation
is:
[a] 25°C (C=1, water) = ~ -17°
.405 nm
Its empirical formula is C10H16N2O4S3•HCl and its structural formula
is:
Dorzolamide hydrochloride has a molecular weight of 360.91. It is a
white to off-white, crystalline
powder, which is soluble in water and slightly soluble in methanol and
ethanol.
Timolol maleate is described chemically as:
(-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5- thiadiazol-
3-yl)oxy]-2-propanol maleate (1:1) (salt).Timolol maleate possesses an
asymmetric carbon atom in its
structure and is provided as the levo-isomer.The optical rotation of
timolol maleate is:
[a] 25°C in 1N HCl (C = 5) = -12.2° (-11.7° to -12.5°)
.405 nm
Its molecular formula is C13H24N4O3S•C4H4O4 and its structural
formula is:
Timolol maleate has a molecular weight of 432.50. It is a white,
odorless, crystalline powder which is
soluble in water, methanol, and alcohol. Timolol maleate is stable at
room temperature.
Dorzolamide hydrochloride – timolol maleate is supplied as a
sterile, isotonic, buffered, slightly
viscous, aqueous solution. The pH of the solution is approximately
5.65, and the osmolarity is 242-323
mOsM. Each mL of dorzolamide hydrochloride – timolol maleate
contains 20 mg dorzolamide (22.26
mg of dorzolamide hydrochloride) and 5 mg timolol