COSOPT- dorzolamide hydrochloride and timolol maleate solution/ drops

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Dorzolamide Hydrochloride (UNII: QZO5366EW7) (Dorzolamide - UNII:9JDX055TW1), Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR)

可用日期:

Akorn

INN（国际名称）:

Dorzolamide Hydrochloride

组成:

Dorzolamide 20 mg in 1 mL

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

COSOPT® 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 COSOPT 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)]. COSOPT is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1)]. COSOPT is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see Warnings and Precautions (5.2)]. COSOPT is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.3)]. Teratogen

產品總結:

COSOPT® (dorzolamide hydrochloride and timolol maleate ophthalmic solution) 2% / 0.5% is supplied in 10 mL white low-density polyethylene (LDPE) plastic bottles with white LDPE dropper tips and blue P/P caps as follows: NDC 17478-605-10 10 mL capacity bottle. Storage: Store at 20° to 25°C (68° to 77°F). Protect from light. After opening, COSOPT can be used until the expiration date on the bottle.

授权状态:

New Drug Application

产品特点

COSOPT- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COSOPT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COSOPT.
COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC
SOLUTION), FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
COSOPT 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 COSOPT 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 COSOPT 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
COSOPT 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 Disease (5.4)
Increased Reactivity to Allergens (5.5)
Potentiation of Muscle Weakness (5.6)
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus
(5.7)
Masking of Thyrotoxicosis (5.8)
Renal and Hepatic Impairment (5.9)
Impairment of Beta-Adrenergically Mediated Reflexes During Surgery
(5.10)
ADVERSE REACTIONS
The most frequently reported adverse reactions were taste perversion
(bit