DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with sinus bradycardia, second or third degree atrioventricula

Product summary:

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% / 0.5% is a clear, colorless to nearly colorless, slightly viscous solution packed in 10 mL white opaque bottle with white LDPE nozzle and blue color HDPE cap. 10 mL in a 10 mL bottle    NDC 65862-946-01 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
AUROBINDO PHARMA LIMITED
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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, FOR
TOPICAL
OPHTHALMIC USE
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 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)