Timoptic-XE (Timolol Maleate Ophthalmic) - Indications and Dosage

INDICATIONS AND USAGE

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 TIMOPTIC‑XE. (See PRECAUTIONS, Information for Patients and 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 Sterile Ophthalmic Gel Forming Solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution.

No. 3557 — TIMOPTIC‑XE Sterile Ophthalmic Gel Forming Solution, 0.25% timolol equivalent, is supplied in an OCUMETER® PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with yellow label as follows:

NDC 0006-3557-35, 5 mL in a 7.5 mL capacity bottle.

No. 3558 — TIMOPTIC‑XE Sterile Ophthalmic Gel Forming Solution, 0.5% timolol equivalent, is supplied in an OCUMETER PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with yellow label as follows:

NDC 0006-3558-35, 5 mL in a 7.5 mL capacity bottle.  

Storage

Store at 15-30°C (59-86°F). AVOID FREEZING. Protect from light.

Manuf. for:
MERCK & CO., Inc., Whitehouse Station, NJ 08889, USA

By: Laboratories Merck Sharp & Dohme-Chibret
63963 Clermont-Ferrand Cedex 9, France

Issued September 2005

325A-07/05 514042Z

9611903