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Ischemic Heart Disease Following Abrupt Withdrawal — Hypersensitivity to catecholamines has been observed in patients withdrawn from beta blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.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.
|
| |
BLOCADREN SUMMARY
BLOCADREN®
(TIMOLOL MALEATE)
TABLETS
BLOCADREN (Timolol Maleate) is a non-selective beta-adrenergic receptor blocking agent. The chemical name for timolol maleate is ( S)-1-[(1,1-dimethylethyl)amino] -3- [ [4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol ( Z)-2-butenedioate (1:1) salt. It possesses an asymmetric carbon atom in its structure and is provided as the levo isomer.
BLOCADREN is indicated for the following:
Hypertension
BLOCADREN is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Myocardial Infarction
BLOCADREN is indicated in patients who have survived the acute phase of a myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction.
Migraine
BLOCADREN is indicated for the prophylaxis of migraine headache.
|
NEWS HIGHLIGHTS
Published Studies Related to Blocadren (Timolol)
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.
Clinical Trials Related to Blocadren (Timolol)
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.
Effect of Xalacom® (Latanoprost/Timolol) and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension [Recruiting]
Glaucoma is one of the most common causes of blindness in the industrialized nations. For a
long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)
leads to irreversible optic disc damage and subsequent visual field loss. However, recent
investigations show that IOP is not the only factor that is involved in the glaucomatous
process leading to retinal ganglion cell death. The role of vascular factors in the
pathogenesis of glaucoma has recently received much attention based on animal experiments
and epidemiological studies. The main focus of glaucoma is still directed towards a decrease
in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence
ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of
innovative techniques have been realized which cover different aspects of ocular perfusion.
In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan®
(brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well
as their ocular hemodynamic effects.
Interaction Study of Timolol Eye Drops and Paroxetine Capsules [Recruiting]
The aim of the study is to investigate the effect of antidepressant paroxetine, on the
plasma levels of timolol and its main metabolites after topical application of ophthalmic
timolol products.
This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy
male volunteers aged 18 - 40 years will be enrolled.
Placebo or paroxetine will be given for three days after which 1 drop of timolol product
will be administered once in both eyes.
The duration of the paroxetine or placebo treatment period will be 3 days. There will be
four different treatment periods. A washout between the study periods will be at least 4
weeks.
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.
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension [Recruiting]
This study compares patient symptoms and anterior segment safety in patients treated with
timilol hemihydrate, generic timolol gel forming solution or timolol maleate.
|
|
|
|
Page last updated: 2009-10-20
|
