Drug Catalog - Product Detail
TIMOLOL MALEATE OPHTH SOL SOL 0.0025 15ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 61314-0226-15 | SANDOZ | 15 | 0.25% | SOLUTION |
Generic Name
Substance Name
Product Type
Route
Application Number
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 optical rotation of timolol maleate is: [α] 25° in 1.0N HCl (C = 5%) = -12.2° ( -11.7° to -12.5°). 405 nm 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 USP is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two do sage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic solution 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH (6.5 to 7.5), and purified water. Benzalkonium chloride 0.01% is added as preservative. chemical
How Supplied
HOW SUPPLIED Sterile timolol maleate ophthalmic solution USP is a clear, colorless solution. Timolol maleate ophthalmic solution, 0.25% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-226-05 5 mL NDC 61314-226-10 10 mL NDC 61314-226-15 15 mL Timolol maleate ophthalmic solution, 0.5% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-227-05 5 mL NDC 61314-227-10 10 mL NDC 61314-227-15 15 mL Storage : Store at room temperature 15° - 30°C (59° - 86°F). Protect from freezing. Protect from light. * BLOCADREN is a registered trademark of Merck & Co., Inc. Rx Only 340048-0604 Revised: June 2004
Indications & Usage
INDICATIONS AND USAGE Timolol maleate ophthalmic solution USP 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 percent. The usual starting dose is one drop of 0.25 percent 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 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 0.5 percent 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 . )