COSOPT- dorzolamide hydrochloride and timolol maleate solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL - UNII:817W3C6175)

Verfügbar ab:

Physicians Total Care, Inc.

INN (Internationale Bezeichnung):

DORZOLAMIDE HYDROCHLORIDE

Zusammensetzung:

DORZOLAMIDE 20 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

COSOPT is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT b.i.d. was slightly less than that seen with the concomitant administration of 0.5% timolol b.i.d. and 2.0% dorzolamide t.i.d. (see CLINICAL PHARMACOLOGY, Clinical Studies). COSOPT is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product. Please follow these instructions carefully when using COSOPT. Use COSOPT as prescribed by your doctor. - If you use other topically applied ophthalmic medications, they should be administered at lea

Produktbesonderheiten:

COSOPT Ophthalmic Solution is a clear, colorless to nearly colorless, slightly viscous solution. No. 3628 — COSOPT Ophthalmic Solution is supplied in an OCUMETER® 2 PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with dark blue label as follows: NDC 54868-4279-0 , 10 mL in an 18 mL capacity bottle. Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Store COSOPT at 15-30°C (59-86°F). Protect from light. 10 mL OCUMETER® PLUS OPHTHALMIC DISPENSER STERILE OPHTHALMIC SOLUTION COSOPT® (DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) Rx only

Berechtigungsstatus:

New Drug Application

Fachinformation

COSOPT - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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COSOPT
(DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION)
STERILE OPHTHALMIC SOLUTION
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:
(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:
[α] 25°C (C=1, water) = ~ -17°.
405 nm
Its empirical formula is C
H N O S •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:
[α] 25°C in 1N HCl (C=5) = -12.2° (-11.7° to -12.5°).
405 nm
Its molecular formula is C
H N O S•C H O 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.
®
10
16
2
4
3
13
24
4
3
4
4
4
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