DORZOLAMIDE AND TIMOLOL- dorzolamide hydrochloride and timolol maleate ophthalmic solution solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Disponible des:

Leading Pharma, LLC

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 atrioventricul

Resumen del producto:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is a sterile, isotonic, buffered, slightly viscous, aqueous solution. Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is supplied in a 5mL and 10 mL labeled translucent LDPE bottle with insert cap assembly comprising of a dark blue colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust-cover sealing the bottle cap. NDC 69315-305-05,    5mL in a 5mL bottle NDC 69315-305-10,    10 mL in a 10 mL bottle Storage Store Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP at 20° to 25°C (68° to 77°F). Protect from light. After opening, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DORZOLAMIDE AND TIMOLOL - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL
MALEATE OPHTHALMIC SOLUTION SOLUTION
LEADING PHARMA, LLC
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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 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 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)
DOSAGE FORMS AND STRENGTHS
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP
containing 20 mg/mL
dorzolamide (2%) equivalent to 22.26 mg/mL of dorzolamide
hydrochloride and 5 mg/mL timolol (0.5%)
equivalent to 6.83 mg/mL of timolol maleate. (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride and 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
P