DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Gland Pharma Limited

Via di somministrazione:

OPHTHALMIC

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP 2% / 0.5% is supplied in 10 mL round white opaque screw neck LDPE bottle with blue HDPE ring modified screw cap as follows: NDC 68083-490-01 10 mL capacity bottle.   Storage : Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. After opening, dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP can be used until the expiration date on the bottle.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
GLAND PHARMA LIMITED
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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
Ophthalmic Solution containing 20 mg/mL (2%) dorzolamide and 5 mg/mL
(0.5%) timolol. (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
• Potentiation of Respiratory Reactions Including Asthma (5.1)
• Cardiac Failure (5.2)
• Sulfonamide Hypersensit