Rx Item-Dorzolamide-Timolol Gen Cosopt Drops 10Ml By Sandoz Falcon Pharma

Clinical Information
Gen. Code and Des.
39531 dorzolamide HCl/timolol maleat OPHTHALMIC DROPS 22.3-6.8/1
GCN and Des.
95919 dorzolamide HCl/timolol maleat OPHTHALMIC DROPS 22.3-6.8/1
Strength
22.3-6.8MG
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
52401200 CARBONIC ANHYDRASE INHIBITORS (EENT)
52400800 BETA-ADRENERGIC BLOCKING AGENTS (EENT)
Active Ingredients
1856 timolol maleate 26921175
4999 dorzolamide HCl 130693822
Inactive Ingredients
2272 mannitol 69658
2332 sodium citrate 68042
3141 benzalkonium chloride 8001545




COSOPT- dorzolamide hydrochloride and timolol maleate solution
Merck Sharp & Dohme Corp.

DESCRIPTION

COSOPT� (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-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:



[α] 25�C (C=1, water) = ~ -17�.

405 nm

Its empirical formula is C10 H16 N2 O4 S3 �HCl and its structural formula is:

chemical structure for dorzolamide hydrochloride
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:

[α] 25�C in 1N HCl (C = 5) = -12.2� (-11.7� to -12.5�).

405 nm

Its molecular formula is C13 H24 N4 O3 S�C4 H4 O4 and its structural formula is:

chemical structure for timolol maleate
(click image for full-size original)
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.

COSOPT 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 COSOPT contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.

Dorzolamide-Timolol 22.3 6.8 1 Drops 10M
Item No.:RX076909/b, Item No. RX076909, 076909, NDC No.: 61314-0030-02, 61314-030-02, 6131403002, 61314003002, 0030-02, 003002 UPC No. 3-61314-03002-3, 361314-030023, 361314030023,

Dorzolamide-Timolol 22.3 6.8 1
Item No.:RX076909/b, Item No. RX076909, 076909, NDC No.: 61314-0030-02, 61314-030-02, 6131403002, 61314003002, 0030-02, 003002 UPC No. 3-61314-03002-3, 361314-030023, 361314030023,

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DORZOLAMIDE HCL/TIMOLOL M
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