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:

Bausch & Lomb Incorporated

INN (International Name):

Dorzolamide Hydrochloride

Composition:

Dorzolamide 20 mg in 1 mL

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 supplied in a white low-density polyethylene (LDPE) bottle with a white LDPE dropper tip and a blue polypropylene cap as follows: Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light. After opening, dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP can be used until the expiration date on the bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
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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
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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:
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequently reported adverse reactions were taste perversion
(bitter, sour, or unusual taste) or
ocular burning and/or stinging in up to 30% of patients. Conjunctival
hyperemia, blurred vision, superficial
punctate keratitis or eye itching were reported between 5 to 15% of
patients. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH & LOMB
INCORPORATED AT 1-800-
553-5340 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a
carbonic anhydrase inhibitor
with 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.