Drug Catalog - Product Detail
TIMOLOL MALEATE 0.5% OPHTH SOL 1X5ML BTL
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60758-0801-05 | GREENSTONE | 5 | 0.5% | SOLUTION |
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Description
DESCRIPTION Timolol Maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol Maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The nominal optical rotation of Timolol Maleate is: Its molecular formula is C 13 H 24 N 4 O 3 S • C 4 H 4 O 4 and its structural formula is: Timolol Maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate ophthalmic solution is stable at room temperature. Timolol Maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol Maleate in two dosage strengths: Each mL, for ophthalmic administration, of 0.25% solution contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0. Each mL, for ophthalmic administration, of 0.5% solution contains 5 mg of timolol (6.8 mg of Timolol Maleate). Inactive ingredients: monobasic and dibasic sodium phosphate; hydrochloric acid and/or sodium hydroxide to adjust pH; and purified water. Benzalkonium chloride 0.01% is added as preservative. Structural Formula Structural Formula
How Supplied
HOW SUPPLIED Timolol Maleate ophthalmic solution, USP is a clear, colorless to light yellow solution. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 60758-802-05 10 mL in 15 mL bottle NDC 60758-802-10 Timolol Maleate ophthalmic solution, 0.5% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 60758-801-05 10 mL in 15 mL bottle NDC 60758-801-10 15 mL in 15 mL bottle NDC 60758-801-15 Storage: Store at 15°-25°C (59°-77°F). Protect from freezing. Protect from light. Revised: 04/2017 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612 Made in the U.S.A. PHARMACIST - DETACH AND GIVE INSTRUCTIONS TO PATIENT Please detach at the perforation to separate the patient information.
Indications & Usage
INDICATIONS AND USAGE Timolol Maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage and Administration
DOSAGE AND ADMINISTRATION Timolol Maleate ophthalmic solution is available in concentrations of 0.25% and 0.5%. The usual starting dose is one drop of the 0.25% Timolol 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% solution in the affected eye(s) twice a day. Since in some patients the pressure-lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol. 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 a 0.5% Timolol 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 ).