DORZOLAMIDE HCL AND TIMOLOL MALEATE hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)

Available from:

Actavis Pharma, Inc.

INN (International Name):

DORZOLAMIDE HYDROCHLORIDE

Composition:

DORZOLAMIDE 20 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HCL AND TIMOLOL MALEATE- DORZOLAMIDE HYDROCHLORIDE AND
TIMOLOL
MALEATE SOLUTION
ACTAVIS PHARMA, INC.
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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, USP
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP 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, 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-timolol maleate
ophthalmic solution in the affected eye(s) two times
daily. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 20 mg/mL dorzolamide and 5 mg/mL timolol. (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride-timolol maleate ophthalmic solution 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 Patients wi