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Timoptic

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Timoptic

Timoptic

INDICATIONS

TIMOPTIC (timolol maleate ophthalmic solution) Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

DOSAGE AND ADMINISTRATION

TIMOPTIC (timolol maleate ophthalmic solution) Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent TIMOPTIC (timolol maleate ophthalmic solution) in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day.

Since in some patients the pressure-lowering response to TIMOPTIC (timolol maleate ophthalmic solution) may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTIC (timolol maleate ophthalmic solution) .

If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Dosages above one drop of 0.5 percent TIMOPTIC (timolol maleate ophthalmic solution) twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS: DRUG INTERACTIONS, Beta-adrenergic blocking agents.)

HOW SUPPLIED

Sterile Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution) is a clear, colorless to light yellow solution.

No. 8895 — TIMOPTIC (timolol maleate ophthalmic solution) Ophthalmic 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 0006-8895-35, 5 mL in a 7.5 mL capacity bottle

No. 8896 — TIMOPTIC (timolol maleate ophthalmic solution) Ophthalmic 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 0006-8896-35, 5 mL in a 7.5 mL capacity bottle
NDC 0006-8896-36, 10 mL in an 18 mL capacity bottle.

Storage

Store at room temperature, 15-30°C (59-86°F). Protect from freezing. Protect from light.

By: Laboratories Merck Sharp & Dohme-Chibret, 63963 Clermont-Ferrand Cedex 9, France. Issued September 2005. FDA rev date: 4/26/2006

Last reviewed on RxList: 10/11/2011
This monograph has been modified to include the generic and brand name in many instances.

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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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