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 metoprolol tartrate, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol tartrate 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 metoprolol tartrate therapy abruptly even in patients treated only for hypertension.
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METOPROLOL SUMMARY
Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration.
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to 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 Metoprolol
Factorial Study of Metoprolol Succinate TOPROL-XL (324A) [Completed]
The purpose of this research study is to determine if treatment with the combination of
metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure
than treatment with either of the two drugs alone. The study will also determine which
combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering
blood pressure (without unacceptable side effects), and whether it is possible to combine
both drugs in a single tablet to simplify blood pressure treatment.
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol
tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg
tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed
conditions.
Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol
tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100
mg) dose administered under fed conditions.
307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects [Completed]
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and
pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol
CR/XL) in hypertensive pediatric subjects. The study population included school age children
(age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to
16 years old) of both genders. Because response to some therapies in adult hypertension
appears to be different in black and non-black populations, the recruitment will have a
mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a
subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the
13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough
plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18)
with the exception of those subjects who completed Protocol 307B (16 week open-label
treatment).
Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan metoprolol
tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets
following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.
Reports of Suspected Metoprolol Side Effects
Completed Suicide (26),
Cardiogenic Shock (22),
Hypotension (16),
Cardiac Arrest (14),
Overdose (13),
Intentional Overdose (11),
Hypokalaemia (10),
Bradycardia (10),
Dyspnoea (9),
Hypoglycaemia (8), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Metoprolol has an overall score of 8.40. The effectiveness score is 8.40 and the side effect score is 8.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Metoprolol review by 53 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | tachycardia |
| Dosage & duration: | | 50mg taken once per day for the period of on-going since 2006 |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I have very few racing heart episodes since I have been on this medication. |
| Side effects: | | The side effect has been a slight decrease in my metabolism. I gained 5 pounds within 3 weeks of starting the medication. But, the benefit greatly outweighs this minor side effect. A purposeful increase in daily exercise has helped to prevent further weight gain. |
| Comments: | | I take one 50 mg pill once per day with food or milk. |
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| | Metoprolol review by 56 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | hypertension |
| Dosage & duration: | | 100 mg taken 1 x daily for the period of 3 years |
| Other conditions: | | none |
| Other drugs taken: | | Lotrel | | |
Reported Results |
| Benefits: | | My blood pressure readings have improved. |
| Side effects: | | There were no side effects. I have tolerated the drug very well. |
| Comments: | | I have taken this drug daily for three years for hypertension in combination with Lotrel. My blood pressure readings have dropped from 160/120 to 120/80. The drug has been effective and well-tolerated. |
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| | Metoprolol review by 36 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure |
| Dosage & duration: | | 50 MG taken once daily for the period of 1 year and counting |
| Other conditions: | | diabetes sarcoidosis |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no headaches (had salt sensitive migraines) |
| Side effects: | | dizzy, vomiting. my bp is sometimes too low especially after exercise but I am not having headaches as long or often |
| Comments: | | once daily, bp check every 3 months, bp checks at home, watch diet (no added salt), lose weight. I have to go to dr. every so often for liver/kidney/glucose check too. |
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Page last updated: 2011-12-09
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