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Timolol GFS Indications, Dosage, Storage, Stability - Timolol Maleate

Timolol GFS Indications, Dosage, Storage, Stability - Timolol Maleate

INDICATIONS AND USAGE

Timolol GFS 0.25% and 0.5% are 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 Timolol GFS (See PRECAUTIONS, Information for Patients).Timolol GFS is available in concentrations of 0.25%,and 0.5%.The dose is one drop of Timolol GFS (either 0.25% or 0.5%) in the affected eye(s) once daily. Because in some patients the intraocular pressure-lowering response to Timolol GFS may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol GFS. Dosages higher than one drop of 0.5% Timolol GFS once daily 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. Other topically applied ophthalmic medications should be administered at least 10 minutes before Timolol GFS.(See PRECAUTIONS, Information for Patients.)

HOW SUPPLIED

Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution supplied in a DROP-TAINER® package system.

Timolol GFS,0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

0.25% NDC 61314-224-25,2.5 mL fill NDC 61314-224-05,5 mL fill

0.5% NDC 61314-225-25,2.5 mL fill NDC 61314-225-05,5 mL fill

Storage

Store between 2º and 25ºC (36º and 77ºF).Protect from light.

Rx Only

*TIMOPTIC and BLOCADREN are Registered trademarks of Merck & Co.,Inc. © 2001 Falcon Pharmaceuticals, Ltd.

Dist. By: Falcon Pharmaceuticals,Ltd., Fort Worth,Texas 76134 USA, Mfd.By: ALCON LABORATORIES,INC. Fort Worth,Texas 76134 USA

Updated June 17, 2004

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