DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE 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:

Aurobindo Pharma Limited

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 with s

Product summary:

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP (Preservative Free) is a clear, colorless to nearly colorless, slightly viscous solution packed in natural LDPE BFS container and supplied in a foil pouch containing 15 low density polyethylene 0.2 mL fill single-use containers. Carton of 4 pouches                       NDC 65862-947-60 Carton of 12 pouches                     NDC 65862-947-18 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE
FREE - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE
FREE SOLUTION/ DROPS
AUROBINDO 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 (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