DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Ingenus Pharmaceuticals, LLC

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Dorzolamide hydrochloride and 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 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 (14.1)]. Dorzolamide hydrochloride and 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 and timolol maleate ophthalmic solution (preservative free) is contraindicated in patients

Tuoteyhteenveto:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP (preservative free) is supplied in a foil pouch containing 5 low density polyethylene 0.2 mL single-use containers. Carton of 12 pouches         NDC 50742-323-60, package of 60 single-use vials. Store dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP (preservative free) at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
INGENUS PHARMACEUTICALS, 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 (PRESERVATIVE
FREE) SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE
HYDROCHLORIDE AND
TIMOLOL MALEATE OPHTHALMIC SOLUTION (PRESERVATIVE FREE).
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
(PRESERVATIVE FREE).
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Dorzolamide hydrochloride and 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 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 (preservative
free) 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 and timolol maleate ophthalmic solution
(preservative free) 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)
Obst