BOX WARNING Ischemic Heart Disease:
Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered TOPROL-XL, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1−2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL administration should be reinstated 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 TOPROL-XL therapy abruptly even in patients treated only for hypertension.
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TOPROL-XL SUMMARY
TOPROL-XL®
(metoprolol succinate)
EXTENDED-RELEASE TABLETS
TABLETS: 25 MG, 50 MG, 100 MG, AND 200 MG
TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt).
Hypertension
TOPROL-XL is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
TOPROL-XL is indicated in the long-term treatment of angina pectoris.
Heart Failure
TOPROL-XL is indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, TOPROL-XL decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
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NEWS HIGHLIGHTS
Published Studies Related to Toprol-XL (Metoprolol)
Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS ? A randomized controlled trial. [2011.12]
Abstract Aim. To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in hypertension...
Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure-a randomized study. [2011.10.15]
ABSTRACT: BACKGROUND: Carvedilol has been shown to be superior to metoprolol tartrate to improve clinical outcomes in patients with heart failure (HF), yet the mechanisms responsible for these differences remain unclear. We examined if there were differences in endothelial function, insulin stimulated endothelial function, 24 hour ambulatory blood pressure and heart rate during treatment with carvedilol, metoprolol tartrate and metoprolol succinate in patients with HF... CONCLUSION: Endothelial function remained unchanged when switching the beta blocker treatment from carvedilol to either metoprolol tartrate or metoprolol succinate in this study, where blood pressure and heart rate also remained unchanged in patients with mild HF. TRIAL REGISTRATION: Current Controlled Trials NCT00497003.
beta-Blockers in patients with intermittent claudication and arterial hypertension: results from the nebivolol or metoprolol in arterial occlusive disease trial. [2011.08]
The use of beta-receptor blockers in peripheral arterial disease is controversial for their impact on vasomotor tone... In the direct comparison, there was no significant difference between nebivolol and metoprolol.
Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. [2011.06]
The aim of this study was to investigate the effects of the vasodilating beta-blocker nebivolol and the cardioselective beta-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness... This proof-of-principle study provides evidence to suggest that beta-blockers with vasodilating properties may offer advantages over conventional beta-blockers in antihypertensive therapy; however, this remains to be tested in a larger trial.
The effect of nebivolol versus metoprolol succinate extended release on asymmetric dimethylarginine in hypertension. [2011.05]
This study sought to determine if metoprolol succinate ER (MET), and nebivolol (NEB), a beta1-AR with increased bioavailability of nitric oxide (NO), would have differing effects on plasma asymmetric dimethylarginine concentration in hypertensives. It was hypothesized that NEB, a beta1-AR antagonist and beta3-AR agonist with NO-releasing properties, and MET, only a beta1-AR antagonist, would have different effects on plasma asymmetric dimethylarginine (ADMA) concentration...
Clinical Trials Related to Toprol-XL (Metoprolol)
Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function [Recruiting]
Beta-blockers (BB) are an important treatment for high blood pressure and heart disease.
However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits
successful use of this class of medications. Sexual side effects often result in drug
discontinuation, compromising therapy goals. The investigators are conducting the study to
determine if nebivolol, a newer beta blocker that is selective for receptors in the heart
and causes vasodilation in the body causes fewer sexual side effects, or even improves
sexual function, compared with metoprolol succinate.
The Impact of Nebivolol Versus Metoprolol on Quality of Life [Not yet recruiting]
In an open label analysis, nebivolol has been shown to have a positive impact on quality of
life in the general hypertensive population. That is, patients treated with nebivolol
reported less side effects compared to those treated with metoprolol. Also, more nebivolol
treated patients reached normalization of blood pressure. Although there is no data, it is
believed that the impact would be similar in renal transplant recipients.
The primary goal of this study is to determine if nebivolol will improve the quality of life
measurements of kidney transplant recipients as compared to those treated with metoprolol
succinate. This will be measured by comparing the scores of four quality of life
questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of
this study are to determine if the use of nebivolol is cost-effective in the renal
transplant recipient; determine if there is a change in urine protein excretion and renal
function with the use of nebivolol; and determine the number of patients that maintain or
achieve a target blood pressure of ≤ 120/80 mmHg.
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients [Not yet recruiting]
The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension [Recruiting]
High blood pressure (hypertension) is called the "silent killer" because many people do not
know they have it, and do not know when it is well controlled. Unfortunately, over time
uncontrolled hypertension can cause irreversible organ damage that can lead to heart attack,
stroke, heart failure, and kidney failure. If a person cannot control their blood pressure
with diet and exercise, doctors often prescribe medications to help control the blood
pressure. Nebivolol is a medication that has been recently approved by the FDA for the
treatment of hypertension. Our study will investigate whether treatment with nebivolol, as
compared to another medication called metoprolol, in African Americans with hypertension
will be more effective in protecting blood vessels against the harmful effects of high blood
pressure.
Over time high blood pressure causes hardening of the arteries (atherosclerosis) which leads
to narrowing of the blood vessels and reduces blood flow to our organs. Arteries also relax
and contract naturally, which further changes the blood supply. When arteries are narrowed,
exercise can bring on a condition in which the blood supply is inadequate, and this might
result in the sensation of pain.
Cells lining our blood vessels produce a variety of substances that normally cause arteries
to relax. Two of these substances are called nitric oxide (NO) and endothelium-derived
hyperpolarizing factor (EDHF). We are trying to determine the nature of these substances in
African Americans with high blood pressure and how it is affected by nebivolol and
metoprolol. One way to determine this is to inject drugs such as L-NMMA
(N(G)-monomethyl-L-arginine) or TEA (tetraethylammonium chloride), which block the
production of NO and EDHF respectively, and then study what happens to the blood flow at
rest and during exercise. It is our thought that nebivolol, in comparison to metoprolol,
will increase the substances that naturally cause arteries to relax and improve blood
supply.
Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol [Recruiting]
This study proposes to assess the effect of the standard of care, which is continuation of
the pre op beta blocker dose into the post operative period compared to the administration
of esmolol titrated to a pre determined target HR. The primary outcome will compare
postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on
metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been
withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes
will compare a) the hemodynamic responses, documenting the incidence of unplanned
hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of
myocardial ischemia, arrhythmias, delirium and infarction.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Toprol-XL has an overall score of 8. The effectiveness score is 7 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Toprol-XL review by 47 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | High Blood pressure |
| Dosage & duration: | | 50 mg. taken 1 daily for the period of 2 years |
| Other conditions: | | breast cancer |
| Other drugs taken: | | Dexameth 4mg., Vicodin 500mg., Compazine 10mg. Chemotherapy- Taxotere/Cytoxan 4tx., Neulasta | | |
Reported Results |
| Benefits: | | Vicodin 500mg- reduced bone pain caused by Neulasta shot.
Dexameth 4mg.- reduced drug reactions caused by chemotherapy.
Compazine 10mg.- reduced nausea caused by chemotherapy.
Taxotere/Cytoxan- going thru tx. at this time. hope to be cancer free!
Neulasta shot- increased whit blood count so we could continue with chemotherapy. |
| Side effects: | | Vicodin 500mg.- some drowsiness
Dexameth 4mg.- hot flashes, flushed face,insomnia
Compazine 10mg.- none
Taxotere- hairloss, very dry skin, some gum bleeding, tiredness, metalic taste in mouth, short term memory loss, confusion, liver toxin level increasing.
Cytoxan- ? since I receive the Taxotere at the same time I'm not sure which side effects are which.
Neulasta shot- extreme bone pain
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| Comments: | | Vicodin 500mg- take as needed for bone pain caused by Neluasta shot.
Dexameth 4mg.- Take 2 tablets night before chemo tx., 2 tablets morning of tx, tablets evening of tx., two tablets am after tx.
Compazine 10mg.- take one tablet every six hours as needed for nasuea from chemo.
Taxotere/Cytoxan- total of four treatments for IDC breast cancer, Grade 1, Stage 2, 0ne lymph node involved. Prior treatment completed- Dec.08 lumpectomy and sentiel node removal, Jan 09 full mastectomy with lypmh node dissection (removed 18), started chemotherapy Feb 22 09 once every three weeks, just had third tx on Mar 31 09.
Neulasta shot- total of four treatments given 48 hours after chemotherapy tx. Shot is given in the stomach area to reduce the side effects. |
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| | Toprol-XL review by 45 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure and |
| Dosage & duration: | | 25mg taken once daily for the period of one year to date |
| Other conditions: | | none |
| Other drugs taken: | | tylenol and advil; ketorolac: frova | | |
Reported Results |
| Benefits: | | It seems to keep my blood pressure and headaches in check, especially during hormonal changes right before my period begins. I am also sleeping better at night (falling asleep and staying asleep; able to get back to sleep during the night), whereas before I was getting only a couple of hours of sleep a night. |
| Side effects: | | none so far |
| Comments: | | I had been dealing with more frequent "migraine" headaches (headaches unresponsive to OTC pain relievers)and began to notice a pattern that was related to my menstrual cycle. During treatment for the headaches with frova and ketorolac I had an episode where I had sudden and severe pain in my head and felt like my head was going to explode, which sent me to the emergency room. The cause was never really determined but in the process it was noticed that my blood pressure was elevated and remained elevated during following doctor visits. Since being on toprol, the headaches and blood pressure have remained managable throughout monthly hormonal changes. |
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Page last updated: 2011-12-09
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