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

TIMOPTIC 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 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 may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTIC.

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 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.)

Sterile Ophthalmic Solution TIMOPTIC is a clear, colorless to light yellow solution.

No. 8895 — TIMOPTIC 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 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.

Manuf. for: MERCK&CO.,INC.,Whitehouse Station, NJ 08889, USA. By: Laboratories Merck Sharp & Dohme-Chibret 63963, Clermont-Ferrand Cedex 9, Franc.e Issued September 2005. FDA Rev date: 4/24/2006

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