DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE- ddorzolamide hydrochloride 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:

Indoco Remedies Limited

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP 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-timolol maleate ophthalmic solution, USP 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 atrioven

Product summary:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP, 2%/0.5% is supplied in 10mL natural, LDPE plastic ophthalmic bottle with a natural nozzle and a dark blue, tamper-evident cap. NDC 14445-405 -10, 10 mL in a 10 mL capacity bottle. Storage:  Store dorzolamide hydrochloride and timolol maleate ophthalmic solution 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 TIMOLOL MALETAE - DDORZOLAMIDE
HYDROCHLORIDE TIMOLOL MALEATE SOLUTION/ DROPS
INDOCO REMEDIES 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, USP
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, USP 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) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing dorzolamide 20 mg/mL (2%) and timolol 5
mg/mL (0.5%). (3) (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is
contraindicated in patients with: (4)
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)
O