February 6, 2016
Recommended Topic Related To:

Timoptic-XE

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Timoptic-XE




Indications
Dosage
How Supplied

INDICATIONS

TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

DOSAGE AND ADMINISTRATION

Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before TIMOPTICXE[see PRECAUTIONS, PATIENT INFORMATIONand accompanying Instructions for Use].

TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution is available in concentrations of 0.25% and 0.5%. The dose is one drop of TIMOPTIC-XE (either 0.25% or 0.5%) in the affected eye(s) once a day.

Because in some patients the pressure-lowering response to TIMOPTIC-XE may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTIC-XE. Dosages higher than one drop of 0.5% TIMOPTIC-XE once a day have not been studied. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. The concomitant use of two topical beta-adrenergic blocking agents is not recommended [see PRECAUTIONS, DRUG INTERACTIONS, Beta-adrenergic blocking agents].

When patients have been switched from therapy with TIMOPTIC administered twice daily to TIMOPTIC-XE administered once daily, the ocular hypotensive effect has remained consistent.

HOW SUPPLIED

TIMOPTIC-XE® (timolol maleate ophthalmic gel forming solution) is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution.

TIMOPTIC-XE® (timolol maleate ophthalmic gel forming solution), 0.25% timolol equivalent, is supplied in a white low density polyethylene (LDPE) dispenser with a controlled drop tip and a yellow polypropylene cap as follows:

NDC 24208-814-25, 5 mL in a 7.5 mL capacity bottle.

TIMOPTIC-XE® (timolol maleate ophthalmic gel forming solution), 0.5% timolol equivalent, is supplied in a white low density polyethylene (LDPE) dispenser with a controlled drop tip and a yellow polypropylene cap as follows:

NDC 24208-816-05, 5 mL in a 7.5 mL capacity bottle.

Storage

Store at 15-25°C (59-77°F). Avoid Freezing. Protect from light.

Distributed by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/22/2015

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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