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 metoprolol on quality of life in the prevention of syncope trial. [2009.10]
INTRODUCTION: Vasovagal syncope is common, often recurrent, and reduces quality of life. No therapies have proven useful to improve quality of life in adequately designed randomized clinical trials. Beta-blockers have mixed evidence for effectiveness in preventing syncope... CONCLUSION: Metoprolol does not improve quality of life in patients with recurrent vasovagal syncope and a positive tilt test.
Beta-receptor selectivity of carvedilol and metoprolol succinate in patients with heart failure (SELECT trial): a randomized dose-ranging trial. [2009.08]
STUDY OBJECTIVE: To determine whether metoprolol succinate (a beta(1)-selective beta-blocker) remains beta(1)-selective compared with carvedilol (a nonselective beta-blocker) during upward titration of doses in patients with American College of Cardiology (ACC) stage C heart failure... CONCLUSION: In this ACC stage C heart failure population, carvedilol was nonselective at all clinically relevant doses, whereas metoprolol succinate was beta(1)-selective at low doses and became progressively nonselective at higher doses.
Antihypertensive efficacy of metoprolol XL/low dose chlorthalidone (6.25 mg) combination: a randomized, comparative study in indian patients with mild-to-moderate essential hypertension. [2009.07.22]
OBJECTIVE: High blood pressure is one of the most important risk factors, directly responsible for increasing the cardiovascular morbidity and mortality. The primary objective was to evaluate the efficacy of metoprolol XL/chlorthalidone against metoprolol XL/hydrochlorothiazide with respect to mean fall in systolic and diastolic blood pressure. The secondary objective was to compare the response rates and to evaluate the tolerability of study medications in patients with mild-to-moderate essential hypertension... CONCLUSION: Chlorthalidone in combination with metoprolol XL is as effective and well tolerated as widely used combination of metoprolol XL/HCTZ, thus providing an alternative therapeutic option.
Prevention of perioperative atrial fibrillation with betablockers in coronary surgery: betaxolol versus metoprolol. [2009.07]
In this study, we tried to compare the efficacy and safety of betaxolol vs. metoprolol immediately postoperatively in coronary artery bypass grafting (CABG) patients and to determine whether prophylaxy for atrial fibrillation (AF) with betaxolol could reduce hospitalization and economic costs after cardiac surgery...
The influence of renal function on clinical outcome and response to beta-blockade in systolic heart failure: insights from Metoprolol CR/XL Randomized Intervention Trial in Chronic HF (MERIT-HF). [2009.05]
CONCLUSIONS: Renal function as estimated by eGFR was a powerful predictor of death and hospitalizations from worsening HF. Metoprolol CR/XL was at least as effective in reducing death and hospitalizations for worsening HF in patients with eGFR < 45 as in those with eGFR > 60.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Metoprolol has an overall score of 7.50. The effectiveness score is 7 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Metoprolol 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 |
| Dosage & duration: | | 25 mg taken twice a day for the period of currently taking |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The benefits of taking this medication have been that my blood pressure is kept in a safe range. I did not experience any negative side effects from taking this medication. The medication came in the form of a small white pill that is easy to swallow. I would recommend this medication for regulating blood pressure. |
| Side effects: | | I did not experience any. |
| Comments: | | I was prescribed to take the medication twice a day in the morning and at night. |
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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: 2009-10-20
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