TRUSOPT OPHTHALMIC SOLUTION

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

DORZOLAMIDE HCL

Tilgjengelig fra:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (International Name):

DORZOLAMIDE HCL

Enheter i pakken:

5 ml

Produsert av:

Santen Pharmaceutical Co., Ltd. Noto Plant

Preparatomtale

Santen PI Blue
PRINTABLE COLOURS:
Profile
Technical Info
NON PRINT:
DESCRIPTION:
GLAMS PART NUMBER:
TECHNICAL DRAWING NO:
2D MATRIX:
DATE:
MARKET:
MATERIAL CODE:
SGK is a Matthews International Corporation
COMMERCIAL
ARTWORK
754776
Trusopt 2% (MY) 5 ml Leaflet
CAW-5804-01
N/A
DIMENSION:
387 X 240 mm
PHARMA CODE:
7842
N/A
14-03-2023
MY
ARTWORK VERSION NUMBER:
SCHAWK JOB NO.:
108421419/403221570
03
CMO SPEC NUMBER:
N/A
CMO ITEM NUMBER:
N/A
LOCAL PRODUCT CIRCULAR
Sterile Ophthalmic Solution
(dorzolamide hydrochloride ophthalmic solution)
I. THERAPEUTIC CLASS
TRUSOPT (dorzolamide hydrochloride ophthalmic solution) is a
novel carbonic anhydrase inhibitor formulated for topical
ophthalmic use. Unlike oral carbonic anhydrase inhibitors,
TRUSOPT, which is administered topically, exerts its effects
directly in the eye.
II. CHEMISTRY
TRUSOPT Sterile Ophthalmic Solution contains dorzolamide
hydrochloride, which is described chemically as: (4_S-trans_)-4-
(ethylamino)-5,6-dihydro-6-methyl-4_H_-thieno[2,3-_b_] thiopyran-2-
sulfonamide 7,7-dioxide monohydrochloride.
Dorzolamide hydrochloride is optically active.
The specific rotation is
405
α
25°
(C=1, water) = ~ -17°.
Its empirical formula is C
10
H
16
N
2
O
4
S
3
. HCl and its structural
formula is:
Dorzolamide hydrochloride has a molecular weight of 360.9 and a
melting point of about 264°C. It is a white to off-white, free
flowing
crystalline powder, which is soluble in water and slightly soluble in
methanol and ethanol.
III. COMPOSITION
_Active Ingredient (all formulations):_
TRUSOPT Sterile Ophthalmic Solution is supplied as a sterile,
isotonic, buffered, slightly viscous, aqueous solution of
dorzolamide hydrochloride. Each mL of TRUSOPT 2% contains
20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride).
_Inactive ingredients:_
_TRUSOPT Ophthalmic Solution:_ hydroxyethyl cellulose, mannitol,
sodium citrate dihydrate, sodium hydroxide (to adjust pH) and
water for injection. Benzalkonium chloride 0.0075% is added as a
preservative.
IV. CLINICAL PHARMACOLOGY
_IVa. Mech