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Timolol (Timolol Maleate Ophthalmic) - Summary

 



BOX WARNING

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal

Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered timolol maleate, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, timolol maleate administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue timolol maleate therapy abruptly even in patients treated only for hypertension.

 

TIMOLOL SUMMARY

TIMOLOL MALEATE
TABLETS, USP
5 mg, 10 mg and 20 mg

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:        25°
[α]              in 0.1N HCl (C = 5%) = -12.2°.

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


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NEWS HIGHLIGHTS

Published Studies Related to Timolol (Timolol Ophthalmic)

Additive Intraocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% (Cosopt) on Monotherapy With Latanoprost (Xalatan) in Patients With Elevated Intraocular Pressure: A Prospective, 4-week, Open-label, Randomized, Controlled Clinical Trial. [2009.09.02]
PURPOSE: To evaluate the additive effect of dorzolamide/timolol fixed combination in patients under monotherapy with latanoprost... CONCLUSIONS: In our sample, dorzolamide 2%/timolol 0.5% fixed combination as add-on therapy in patients with open-angle glaucoma or ocular hypertension under monotherapy with latanoprost with IOP already in mid-teens levels may further enhance pressure reduction.

Dorzolamide-timolol combination and retinal vessel oxygen saturation in patients with glaucoma or ocular hypertension. [2009.08]
AIMS: To examine whether the addition of dorzolamide to timolol monotherapy influences oxygen saturation in the human retina... CONCLUSION: Adding dorzolamide to timolol monotherapy has a minimal effect, but going from dorzolamide-timolol combination to timolol alone lowered arteriolar and venular oxygen saturation. The retinal oxygen saturation measurements show a high degree of stability over an extended period of time. Previous studies have suggested increased retinal and optic nerve blood flow with dorzolamide. Unchanged oxygen saturation and increased blood flow would indicate increased oxygen delivery to the retina.

Pneumatic trabeculoplasty vs latanoprost as adjunctive therapy to timolol in primary open-angle glaucoma or ocular hypertension. [2009.08]
CONCLUSIONS: In eyes with glaucomatous damage that is not advanced, PNT can reduce the IOP in 60% of the eyes at 1 month, and in 33% of the eyes at 3 months, without significant side-effects. The indications, efficacy and safety of PNT retreatments remain to be investigated. IOP reduction is less and of shorter duration than that obtained by latanoprost adjunctive therapy.

A comparison of the long-term effects of dorzolamide 2% and brinzolamide 1%, each added to timolol 0.5%, on retrobulbar hemodynamics and intraocular pressure in open-angle glaucoma patients. [2009.06]
PURPOSE: To compare the effect on the retrobulbar hemodynamics and intraocular pressure (IOP) of dorzolamide 2% and brinzolamide 1%, each added to timolol 0.5% in patients with primary open-angle glaucoma (POAG)... CONCLUSIONS: Our results suggest augmented retrobulbar blood flow after 5 years of treatment with dorzolamide but not with brinzolamide, each added to timolol, in POAG patients.

24-hour intraocular pressure and blood pressure levels with latanoprost/timolol fixed combination versus timolol. [2009.05]
PURPOSE: To evaluate 24-hr intraocular pressure (IOP) and blood pressure (BP) with timolol or latanoprost/timolol fixed combination (LTFC)... CONCLUSIONS: Neither timolol or evening-dosed LTFC reduced SBP, DBP, MBP, OPP, or increased nocturnal dipping. LTFC was more effective than timolol in decreasing IOP.

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Clinical Trials Related to Timolol (Timolol Ophthalmic)

24-Hour IOP Control With Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combination in Open-Angle Glaucoma [Completed]
The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0. 005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.

Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension [Completed]
This study evaluates the safety and efficacy of brimonidine 0. 2%/timolol 0. 5% fixed combination ophthalmic solution compared with concurrent brimonidine 0. 2% and timolol ophthalmic solutions

Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients [Completed]

MK0507A Phase III Double-Blind, Comparative Study [Completed]
The clinical study compares safety and efficacy of MK0507A (dorzolamide 1. 0% / timolol 0. 5%) with 1) timolol 0. 5% and with 2) concomitant therapy with dorzolamide 1. 0% / timolol 0. 5% in patients with glaucoma and ocular hypertension.

Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension [Completed]
to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

more trials >>

Page last updated: 2009-10-20

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