DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION- dorzolamide hydrochloride and timolol maleate solution/ drops

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Доступна с:

Micro Labs Limited

Администрация маршрут:

OPHTHALMIC

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

  Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) 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 dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1)] . Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindi

Обзор продуктов:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution. Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is supplied in an LDPE white opaque cylindrical shape, screw type neck dispenser bottle closed with a LDPE white opaque cone shaped open nozzle and an HDPE blue color cone shaped TSTR-TEAR off cap as follows. NDC 42571-147-26, 10 mL in a 10 mL capacity bottle. Storage Store Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. After opening, dorzolamide hydrochloride and timolol maleate ophthalmic solution can be used until the expiration date on the bottle.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC
SOLUTION - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/
DROPS
MICRO LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE AND
TIMOLOL
MALEATE OPHTHALMIC SOLUTION.
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a
combination of dorzolamide
hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a
beta adrenergic receptor blocking
agent, indicated for the reduction of elevated intraocular pressure
(IOP) in patients with open-angle
glaucoma or ocular hypertension who are insufficiently responsive to
beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate
ophthalmic solution twice daily was
slightly less than that seen with the concomitant administration of
0.5% timolol twice daily, and 2%
dorzolamide three times daily. ( 1)
DOSAGE AND ADMINISTRATION
The dose is one drop of dorzolamide hydrochloride and timolol maleate
ophthalmic solution in the affected
eye(s) two times daily. ( 2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing dorzolamide 20 mg/mL (2%) and timolol 5
mg/mL (0.5%). ( 3)
CONTRAINDICATIONS
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is
contraindicated in patients with:
Bronchial asthma or a history of bronchial asthma, severe chronic
obstructive pulmonary disease.( 4.1)
Sinus bradycardia, second or third degree atrioventricular block,
overt cardiac failure, cardiogenic
shock. ( 4.2)
Hypersensitivity to any component of this product. ( 4.3, 5.3)
WARNINGS AND PRECAUTIONS
Potentiation of Respiratory Reactions Including Asthma ( 5.1)
Cardiac Failure ( 5.2)
Sulfonamide Hypersensitivity ( 5.3)
Obstructive Pulmonary