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:

Akorn

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) 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 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 (14.1)] . Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) 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-timolol maleate ophthalmic solution (preservative-free) is contraindicated in patients with sinus bra

Product summary:

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is supplied in a foil pouch containing 15 low density polyethylene 0.2 mL single-use containers. NDC 50383-261-61, package of 60 single-use vials in 4 pouches. NDC 50383-261-91, package of 180 single-use vials in 12 pouches. Store Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) at 20° to 25°C (68° to 77°F). Do not freeze. Store in the original pouch. After the pouch is opened, store the remaining single-use containers in the foil pouch to protect from light. Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 15 days after first opening the pouch.

Authorization status:

New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- 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
DORZOLAMIDE
HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION (PRESERVATIVE-FREE)
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE
HYDROCHLORIDE-TIMOLOL
MALEATE OPHTHALMIC SOLUTION (PRESERVATIVE-FREE).
DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION
(PRESERVATIVE-FREE)
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
The dose is one drop of dorzolamide hydrochloride-timolol maleate
ophthalmic solution (preservative-free)
in the affected eye(s) two times daily. (2) (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 20 mg/mL dorzolamide and 5 mg/mL timolol. (3) (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride-timolol maleate ophthalmic solution
(preservative-free) is contraindicated in
patients with: (4)
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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 5-15% of
patients. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HI-TECH PHARMACAL CO.,
INC. AT 1-800-
262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Dorzolamide hydrochloride-timolol maleate ophthalmic solution
(preservative-free) 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-timolol maleate
ophthalmic solution twice daily was
slightly less than that seen with the co