DORZOLAMIDE HCL AND TIMOLOL MALEATE- 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

INN (International Name):

Dorzolamide Hydrochloride

Composition:

Dorzolamide 20 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dorzolamide Hydrochloride-Timolol Maleate 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 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-timolol maleate 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 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)] . Do

Product summary:

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 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 17478-514-11          10 mL capacity bottle. Storage: Store at 20° to 25°C (68° to 77°F). Protect from light. After opening, Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HCL 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 SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE
OPHTHALMIC SOLUTION.
DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION, FOR
TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Dorzolamide Hydrochloride-Timolol Maleate 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-Timolol Maleate 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-Timolol Maleate 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-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)
Increased Reactivity to Allergens (5.5)
Potentiation of Muscle Weakness (5.6)
Masking of Hypoglycemic Symptoms in Pat