Plain-language summary, compiled from the cited regulatory records
Metoprolol is a medication belonging to the drug class of selective beta-blocking agents [1]. It is approved for the treatment of hypertension, where it helps to lower blood pressure, thereby reducing the risk of cardiovascular events such as strokes and heart attacks [1]. Metoprolol is also indicated for managing angina pectoris and reducing cardiovascular mortality in patients following a myocardial infarction, particularly when used alongside intravenous metoprolol therapy [1].
This medication is available under various brand names, including Lopressor [1]. In the past 12 months, there have been 15,736 adverse event reports associated with metoprolol [2]. The most frequently reported adverse events include fatigue, diarrhea, nausea, dyspnea, and off-label use [2].
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised May 19, 2026[1]
1 INDICATIONS AND USAGE Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
1) Angina Pectoris. 1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
GBUnited Kingdom· MHRA
12 products
Uses
GBOfficial regulatory label· revised May 22, 2026[2]
Metoprolol is a beta-adrenoreceptor blocking drug indicated for: hypertension, angina pectoris, cardiac arrhythmias especially supraventricular tachyarrhythmias, migraine prophylaxis, adjunct to treatment of hyperthyroidism, long-term prophylaxis after recovery from acute myocardial infarction.
Early intervention with metoprolol in myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
How to take
CACanada· Health Canada
6 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
5 ADVERSE REACTIONS ........................................................................................... 10 DRUG INTERACTIONS ........................................................................................... 12 DOSAGE AND ADMINISTRATION .........................................................................
18 OVERDOSAGE ......................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 21 STORAGE AND STABILITY ...................................................................................
24 SPECIAL HANDLING INSTRUCTIONS .................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 25 PART II: SCIENTIFIC INFORMATION .........................................................................
Drug interactions
Known interactions involving Metoprolol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 1098f26d-8319-4d… · revised May 19, 2026 [PDF]
[2]MHRA (UK) · PL045690144 · revised May 22, 2026
[3]Health Canada (DPD) · 02350394 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.
Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents. 2 Angina Pectoris Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
3 Heart Failure Metoprolol succinate extended-release tablets are is indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure.
How to take
USOfficial regulatory label· revised May 19, 2026[1]
2 DOSAGE AND ADMINISTRATION Administer once daily. Titrate at weekly or longer intervals as needed and tolerated. (2) Hypertension: Starting dose is 25 to 100 mg. 1) Angina Pectoris: Starting dose is 100 mg. 5 or 25 mg. 3) Switching from immediate-release metoprolol to metoprolol succinate extended-release tablets: use the same total daily dose of metoprolol succinate extended-release tablets.
1 Hypertension Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy.
Dosages above 400 mg per day have not been studied. 4) ] . If selected for treatment, the recommended starting dose of metoprolol succinate extended-release tablets is 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily.
Adjust dosage according to blood pressure response. 3) ]. 4)]. 2 Angina Pectoris Individualize the dosage of metoprolol succinate extended-release tablets. The usual initial dosage is 100 mg daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate.
Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks [see Warnings and Precautions (5)] . 3 Heart Failure Dosage must be individualized and closely monitored during up-titration.
Prior to initiation of metoprolol succinate extended-release tablets, stabilize the dose of other heart failure drug therapy. 5 mg once daily in patients with more severe heart failure. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of metoprolol succinate extended-release tablets.
Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate. If patients experience symptomatic bradycardia, reduce the dose of metoprolol succinate extended-release tablets. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of metoprolol succinate extended-release tablets or temporarily discontinuing it.
The dose of metoprolol succinate should not be increased until symptoms of worsening heart failure have been stabilized. 4 Administration Metoprolol succinate extended-release tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 15,736 reports total. [4]
Fatigue 1,239
Diarrhoea 1,024
Nausea 1,003
Off Label Use 980
Dyspnoea 850
Drug Ineffective 777
Dizziness 718
Death 678
Headache 676
Product Dose Omission Issue 647
Cough 553
Asthenia 517
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 19, 2026[1]
6 ADVERSE REACTIONS Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. 1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
gov/medwatch.
The following adverse reactions are described elsewhere in labeling:
Worsening angina or myocardial infarction [see Warnings and Precautions (5)]. Worsening heart failure [see Warnings and Precautions (5)]. Worsening AV block [see Contraindications (4)]. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Hypertension and Angina:
Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea, shortness of breath, bradycardia, and rash. 3% of metoprolol succinate patients discontinued for adverse reactions vs.
2% of placebo patients. 5%, regardless of the assessment of causality. 4 Post-operative Adverse Events: In a randomized, double blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, metoprolol succinate extended-release tablets 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day.
43), hypotension (15% vs. 74) compared to placebo. 2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of metoprolol succinate extended-release tablets or immediate-release metoprolol.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular:
Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain, and hypotension.
In addition, there are adverse reactions not listed above that have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol succinate extended-release tablets.
Central Nervous System:
Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, clouded sensorium, and decreased performance on neuropsychometrics.
USOfficial regulatory label· Warnings and precautions· revised May 19, 2026[1]
5 WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. 1 ) Heart Failure: Worsening cardiac failure may occur. 2 ) Bronchospastic Disease: Avoid beta-blockers. 3 ) Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia.
4 ) Pheochromocytoma: Initiate therapy with an alpha-blocker. 5 ) Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic beta-blocker therapy prior to surgery.
1 ) Hypoglycemia: May increase risk for hypoglycemia and mask early warning signs. 7 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. 8 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency.
9 ) Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. 1 Abrupt Cessation of Therapy 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 succinate extended-release tablets, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate metoprolol succinate extended-release tablets, and take measures appropriate for the management of unstable angina.
Warn patients not to interrupt therapy without their physician's advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing metoprolol succinate extended-release tablets in patients treated only for hypertension.
2 Heart Failure Worsening cardiac failure may occur during up-titration of metoprolol succinate extended-release tablets. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol succinate extended-release tablets [see Dosage and Administration (2)] .
It may be necessary to lower the dose of metoprolol succinate extended-release tablets or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of metoprolol succinate extended-release tablets. 3 Bronchospastic Disease Patients with bronchospastic diseases should, in general, not receive beta-blockers.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 19, 2026[1]
4 CONTRAINDICATIONS Known hypersensitivity to product components. (4) Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4) Cardiogenic shock or decompensated heart failure. (4) Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third-degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[2]
Posology The dose must always be adjusted to the individual requirements of the patient but should not exceed 400 mg/day.
The following are guidelines:
Adults: Hypertension: Initially, 100 mg daily, increased by 100 mg daily at weekly intervals to 200 mg daily if needed, in single or divided (twice daily) doses. Over the dosage range most patients may be expected to respond rapidly and satisfactorily.
A further reduction in blood pressure may be achieved if Metoprolol tablets are used in conjunction with an antihypertensive diuretic or other hypotensive agent. Metoprolol tablets may be administered with benefit both to previously untreated patients with hypertension and to those in whom the response to previous therapy is inadequate.
In the latter type of patient the previous therapy may be continued and Metoprolol tablets added into the regime with adjustment of the previous therapy if necessary. Angina Pectoris: 50-100 mg two or three times daily. In general a significant improvement in exercise tolerance and reduction of anginal attacks may be expected with a dose of 50-100 mg twice daily.
Cardiac Arrhythmias: 50 mg two or three times daily is usually sufficient. If necessary the dose can be increased up to 300 mg daily in divided doses. Migraine Prophylaxis: 100-200 mg daily in divided doses (morning and evening). Hyperthyroidism: 50 mg four times daily.
The dose should be progressively reduced as the euthyroid state is slowly achieved.
Myocardial Infarction:
Early intervention: 50 mg every six hours for 48 hours, commencing 15 minutes after the last intravenous dose of metoprolol preferably within 12 hours of the onset of chest pain. Maintenance: 100 mg twice daily as a maintenance dose.
Patients who do not tolerate the full intravenous dose of metoprolol should be given half the suggested oral dose.
Paediatric population:
Not recommended.
Older people:
The optimum dose should be individually determined according to clinical response. There is no evidence to suggest that dosage requirements are different in otherwise healthy older patients. However, caution is indicated in older patients as an excessively pronounced decrease in blood pressure or pulse rate may cause the blood supply to vital organs to fall to inadequate levels.
Hepatic Disease:
In patients with significant hepatic dysfunction dosage reduction may be advised. Method of administration Metoprolol tablets should be administered orally and swallowed unchewed.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[2]
Frequency estimates: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). g. g. hypoacusis or deafness) Cardiac disorders Common bradycardia Rare heart failure, cardiac arrhythmias, palpitation Very rare disturbances of cardiac conduction, precordial pain Vascular disorders Common orthostatic hypotension (occasionally with syncope) Rare oedema, Raynaud’s phenomenon Very rare gangrene in patients with pre-existing severe peripheral circulatory disorders Not known Hypotension Very rare gangrene in patients with pre-existing severe peripheral circulatory disorders Respiratory disorders, thoracic and mediastinal Common exertional dyspnoea Rare bronchospasm (which may occur in patients without a history of obstructive lung disease) Very rare rhinitis Gastrointestinal disorders Common nausea and vomiting, abdominal pain Rare diarrhoea or constipation Very rare dryness of the mouth Not known retroperitoneal fibrosis (relationship to metoprolol has not definitely been established) Hepatobiliary disorders Not known hepatitis Skin and subcutaneous tissue disorders Rare skin rash (in the form of urticaria, psoriasiform and dystrophic skin lesions) Very rare photosensitivity, increased sweating, loss of hair, worsening of psoriasis Musculoskeletal and connective tissue disorders Rare muscle cramps Very rare arthritis Reproductive system and breast disorders Very rare disturbances of libido and potency Not known Peyronie’s disease (relationship to metoprolol has not been definitely established) General disorders and administration site conditions Common fatigue Investigations Very rare weight gain, liver function test abnormalities Not known positive anti-nuclear antibodies Post Marketing Experience The following adverse reactions have been reported during post-approval use of metoprolol: confusional state, an increase in blood triglycerides and a decrease in high density lipoprotein (HDL).
Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[2]
Sudden withdrawal of beta-adrenoceptor blocking drugs should be avoided, especially in patients with ischaemic heart disease as it may result in anginal attacks of increased frequency or severity. Therefore, withdrawal of metoprolol should be gradual over 10 days, reducing the dose to 25 mg daily for the last 6 days.
During its withdrawal, the patient should be kept under close surveillance and replacement therapy should be initiated where required. Beta-blockers may increase the number and duration of angina attacks in patients with Prinzmetal’s angina (variant angina pectoris).
However, relatively selective beta1-receptor blockers, such as metoprolol, can be used in such patients, but only with the utmost care. Particular care is required with patients whose cardiac reserve is poor. Beta-adrenoceptor blocking drugs should be avoided in overt heart failure, although they may be used when cardiac failure has been controlled.
Digitalisation and/or diuretic therapy should be considered in patients with a history of heart failure. Cardiac failure due to thyrotoxicosis may respond to metoprolol alone, but if other adverse factors are also present it is important to control signs of failure with cardiac glycosides and diuretics.
3). In patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. A reduction in heart rate is a pharmacological effect of metoprolol. In rare cases where symptoms may be attributable to the slow heart rate (less than 50 to 55 beats/min), the dose should be reduced or gradually withdrawn.
Metoprolol modifies the tachycardia of hypoglycaemia by inhibition of sympathetic nerve functions and it may prolong the hypoglycaemic response to insulin. Patients should be warned accordingly. Care should be exercised during concomitant use of metoprolol and hypoglycaemic therapy in patients with diabetes mellitus.
In labile and insulin-dependent diabetes it may be necessary to adjust the hypoglycaemic therapy. Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. 5). Beta-blockers should be used with great caution in patients with peripheral circulatory disorders (Raynaud’s disease/syndrome, intermittent claudication), and bradycardia, as they may aggravate such disorders.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[2]
g. in some diabetics). Metoprolol is also contraindicated when myocardial infarction is complicated by significant bradycardia, first degree heart block, systolic hypotension (less than 100 mmHg) and/or severe heart failure.
This is not medical advice. Consult a qualified healthcare professional.
33 PART I I I: CONSUMER INFORMATION ...................................................................... 37 Page 3 of 40 PrMETOPROLOL Metoprolol tartrate tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients Oral Film-coated tablets, 50 and 100 mg silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, titanium dioxide and macrogol 100 mg tablets also contain: FD&C blue #2, 50 mg tablets also contain: D&C red #30 and FD&C yellow #6.
INDICATIONS AND CLINICAL USE Hyperte nsion METOPROLOL (metoprolol tartrate) is indicated for mild or moderate hypertension. Usually combined with other antihypertensive agents (thiazide diuretics), it may be tried alone when the physician judges that a beta-blocker, rather than a diuretic, should be the initial treatment.
Combining METOPROLOL with a diuretic or peripheral vasodilator has been found to be compatible and generally more effective than metoprolol tartrate alone. Limited experience with other antihypertensive agents has not shown evidence of incompatibility with METOPROLOL.
METOPROLOL is not recommended for the emergency treatment of hypertensive crises. Angina Pectoris METOPROLOL is indicated for the long-term treatment of angina pectoris due to ischemic heart disease. Myocardial Infarction METOPROLOL is 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 and Precautions). Page 4 of 40 Alternatively, in patients with proven myocardial infarction, oral treatment can begin within 3 to 10 days of the acute event (see Dosage and Administration).
Data are not available as to whether benefit would ensue if the treatment is initiated later. Clinical trials have shown that patients with unconfirmed myocardial infarction received no benefit from early metoprolol tartrate therapy.
Geriatr ics:
Caution is indicated when using METOPROLOL in elderly patients. An excessively pronounced decrease in blood pressure or pulse rate may cause the blood supply to vital organs to fall to inadequate levels.
Pediatrics:
No pediatric studies have been performed. The safety and efficacy of metoprolol tartrate in pediatric patients have not been established. 24 s); systolic blood pressure < 100 mmHg; or moderate to severe cardiac failure (see Warnings and Precautions).
Page 5 of 40 WARNINGS AND PRECAUTIONS Gener al Cardiovascular system:
Special caution should be exercised when administering METOPROLOL (metoprolol tartrate) to patients with a history of heart failure. Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with β- blockade always carries the potential hazard of further depressing myocardial contractility and precipitating cardiac failure.
The positive inotropic action of digitalis may be reduced by the negative inotropic effect of metoprolol tartrate when the two drugs are used concomitantly. The effects of β-blockers and digitalis are additive in depressing A-V […]
How to take
CAOfficial regulatory label· revised March 22, 2025[3]
Recommended Dose and Dosage Adjustment Hypertension METOPROLOL (metoprolol tartrate) is usually used in conjunction with other antihypertensive agents, particularly a thiazide diuretic, but may be used alone (see Indications). The dose must always be adjusted to the individual requirements of the patient, in accordance with the following guidelines.
d. d. , which should not be exceeded. The usual maintenance dose is within the range of 100-200 mg daily. d. After one or two weeks the daily dosage may be increased if required, in increments of 100 mg, at intervals of not less than two weeks, until adequate blood pressure control is obtained.
Given the interactions of METOPROLOL with food, it is recommended that the drug should be administered with or immediately following meals (see Action and Clinical Pharmacology- Pharmacokinetics, Drug Interactions-Drug-Food interactions).
Angina Pectoris The recommended dosage range for METOPROLOL in angina pectoris is 100-400 mg per day in divided doses. d. for the first week. If response is not adequate, the daily dosage should be increased by 100 mg for the next week.
The usual maintenance dose is 200 mg/day. The need for further increases should be closely monitored at weekly intervals and the dosage increased in 100 mg increments to a maximum of 400 mg/day in two or three divided doses. A METOPROLOL dose of 400 mg/day should not be exceeded.
24 seconds < 10 cm *Extreme caution should be exercised when giving intravenous metoprolol to patients with heart rate between 45 and 60 and/or pulmonary rales less than 10 cm. Therapy should be discontinued in patients if the heart rate drops below 45 or the systolic blood pressure drops below 100 mmHg.
Early Treatment During the early phase of definite or suspected acute myocardial infarction, treatment with METOPROLOL can be initiated as soon as possible after the patient's arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized.
Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each. The injections should be given at approximately 2- minute intervals. During the intravenous administration of metoprolol tartrate, blood pressure, heart rate, and electrocardiogram should be carefully monitored.
If any of the injections are associated with adverse cardiovascular effects, intravenous administration should be stopped immediately, and the patient should be observed carefully and appropriate therapy instituted. In patients who tolerate the full intravenous dose (15 mg), METOPROLOL tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours.
Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started on either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows.
In patients with severe intolerance, treatment with METOPROLOL should be discontinued (see Warnings and Precautions). Late Treatment (For proven myocardial infarction patients only) Patients with contraindications to treatment during the early phase of myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on METOPROLOL tablets, 100 mg twice daily, as soon as their clinical condition allows.
Treatment can begin within 3-10 days of the acute event. Therapy should be continued for at least 3 months. Although the efficacy of Page 20 of 40 treatment with METOPROLOL beyond 6 months has not been conclusively established data from studies with other β-blockers suggest that the treatment should be continued for 1-3 years.
Special populations Pediatric patients No pediatric studies have been performed. The safety and efficacy of metoprolol tartrate in pediatric patients have not been established. Renal impairment No dose adjustment of METOPROLOL is required in patients mild to moderate renal impairment.
Caution and regular monitoring of renal function are required in patients with severe renal impairment (see Action and Clinical Pharmacology-Pharmacokinetics-Special populations). Hepatic impairment METOPROLOL blood levels are likely to increase substantially in patients with mild to moderate hepatic impairment.
Therefore, METOPROLOL should be initiated at low doses with cautious gradual dose titration according to clinical response and safety monitoring. e. lower initial and maintenance doses as well as regular monitoring of hepatic function, as they are more sensitive to therapeutic effects/adverse effects of drugs (see Action and Clinical Pharmacology-Pharmacokinetics- Special populations).
Geriatric patients (>65 years) METOPROLOL should be […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
Adverse Drug Reaction Overview The most common adverse events reported are exertional tiredness, gastrointestinal disorders, and disturbances of sleep patterns. The most serious adverse events reported are congestive heart failure, bronchospasm and hypotension.
g. g. 6% Abnormal Hematologic and Clinical Chemistry Findings Clinical Laboratory The following laboratory parameters have been elevated on rare occasions: transaminases, BUN, alkaline phosphatase and bilirubin. Page 12 of 40 Hematology Isolated cases of thrombocytopenia and leucopenia.
Post-Market Adverse Drug Reactions The following adverse reactions have been derived from post-marketing experience with metoprolol tartrate via spontaneous case reports and literature cases. Because these reactions are reported voluntary from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency which is therefore categorized as not known.
Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. Nervous system disorders Confusional state Investigations Blood triglycerides increased, High Density Lipoprotein (HDL) decreased DRUG INTERACTIONS Overview Established or Potential Drug-Drug Interactions (Legend: CT = Clinical Trial; C=Postmarket (Case Study); T = Theoretical) Metoprolol Ref Effect Clinical comment Alcohol C Increased concentration of metoprolol in blood Metoprolol modifies the pharmacokinetics (decreases the elimination rate) of alcohol.
Which may increase certain side effects of metoprolol Anti-adrener gic agents C Potentiate antihypertensive effect of alpha- adrenergic blockers Antihypertensive effect of alpha- adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by β- blockers.
β-adrenergic blockers may also potentiate the postural hypotensive effect of the first dose of prazosin, probably by preventing reflex tachycardia. On the contrary, β- adrenergic blockers may also potentiate the hypertensive response to withdrawal of clonidine as patients receiving concomitant clonidine and β- adrenergic blocker.
Withdrawing the β- blocker several days before the clonidine may reduce the danger of rebound effects. Page 13 of 40 Metoprolol Ref Effect Clinical comment Antiarrhythmic Agents C Potentiate the negative inotropic effect of anti- arrhythmic agents and their effect on atrial-conduction time β-blockers may potentiate the negative inotropic effect of anti-arrhythmic agents and their effect on atrial-conduction time.
Particularly, in patients with pre- existing sinus node dysfunction, concomitant administration of amiodarone may result in additive electro-physiologic effects including bradycardia, sinus arrest, and atrioventricular block antiarrhythmic agents such as quinidine, tocainide, procainamide, ajmaline amiodarone, flecainide and disopyramide may potentiate the effects of metoprolol tartrate on heart rate and atrioventricular conduction.
Other Antihypertensive drugs CT Hypertension METOPROLOL dosage should be adjusted to the individual requirements of the patient especially when used concomitantly with other antihypertensive agents (see Dosage and Administration). Patients receiving concurrent treatment with catecholamine depleting drugs, other beta-blockers (including those in form of eye drops, such as timolol), or monoamine oxidase (MAO) inhibitors, should be carefully monitored.
In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
Gener al Cardiovascular system:
Special caution should be exercised when administering METOPROLOL (metoprolol tartrate) to patients with a history of heart failure. Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with β- blockade always carries the potential hazard of further depressing myocardial contractility and precipitating cardiac failure.
The positive inotropic action of digitalis may be reduced by the negative inotropic effect of metoprolol tartrate when the two drugs are used concomitantly. The effects of β-blockers and digitalis are additive in depressing A-V conduction.
This also applies to combinations with calcium-antagonists of the verapamil type or some antiarrhythmics (see Drug Interactions). In patients without a history of cardiac failure, continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure and/or hypotension (systolic blood pressure ≤ 90 mmHg).
Therefore, at the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or given a diuretic and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic therapy, METOPROLOL therapy should be reduced or withdrawn.
Cardio vasc ular Severe Sinus Bradycardia:
Severe sinus bradycardia may occur after β1-adrenergic receptor blockade with METOPROLOL because of unopposed vagal activity. Very rarely a pre-existing A- V conduction disorder of moderate degree may become aggravated, possibly leading to A-V block.
In such cases, dosage should be reduced or gradually withdrawn. Atropine, isoproterenol or dobutamine should be considered in patients with acute myocardial infarction.
Prinzmetal's angina:
Beta-blockers may increase the number and duration of angina attacks in patients with Prinzmetal's angina (variant angina pectoris).
Peripheral Circulatory Disorders:
Metoprolol may aggravate the symptoms of peripheral arterial circulatory disorders, mainly due to its blood pressure lowering effect.
This is not medical advice. Consult a qualified healthcare professional.
Because of its relative beta 1 - cardio-selectivity, however, metoprolol succinate extended-release tablets may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment.
Because beta 1 -selectivity is not absolute, use the lowest possible dose of metoprolol succinate extended-release tablets. Bronchodilators, including beta 2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2)] .
4 Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of metoprolol succinate extended-release tablets. 3) ], may be at increased risk. Monitor heart rate in patients receiving metoprolol succinate extended-release tablets.
If severe bradycardia develops, reduce or stop metoprolol succinate extended-release tablets. 5 Pheochromocytoma If metoprolol succinate extended-release tablets are used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha-blocker has been initiated.
Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle. 6 Major Surgery Avoid initiation of a high-dose regimen of extended-release metoprolol in patients undergoing non-cardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke, and death.
Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery: however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
, surgery, not eating regularly, or are vomiting). If severe hypoglycaemia occurs, patients should be instructed to seek emergency treatment. 8 Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia.
Abrupt withdrawal of beta-blockade may precipitate a thyroid storm. 9 Peripheral Vascular Disease While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.
10 Anaphylactic Reaction Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions which may be resistant to normal doses of adrenaline. Whenever possible, beta-blockers, including metoprolol, should be avoided for patients who are at increased risk of anaphylaxis.
While cardioselective beta-blockers such as metoprolol may have less effect on pulmonary function than non-selective ones, they should be avoided in patients with reversible obstructive airways disease, a history of asthma and/or bronchospasm unless absolutely necessary.
When administration of metoprolol is required, the use of a beta2-bronchodilator such as terbutaline may be advisable or current therapy may require adjustment in some cases. When beta-blockers are used in patients with a history of bronchial asthma, the possibility of bronchospasm must be considered.
The label will state “Do not take this medicine if you have a history of wheezing or asthma”. Care is required when transferring patients from clonidine to a beta-adrenoceptor blocking drug. If the two drugs are given concurrently, clonidine should not be discontinued until several days after the withdrawal of the beta-adrenoceptor blocking drug.
Beta-adrenoceptor blocking drugs should be used with caution in combination with verapamil where ventricular function is impaired. The combination should not be given to patients with conduction abnormalities, nor should either drug be administered intravenously within 48 hours of discontinuing the other.
5). Care is required when administering anaesthetic agents to patients receiving metoprolol. The anaesthetist should always be informed of the use of a beta-adrenoceptor blocking drug. The risks and benefits of continued beta-blocking therapy in the peri-operative period should be carefully evaluated.
If a beta-blocker is withdrawn prior to surgery it should be discontinued for at least 24 hours. Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. However, the risk of hypertension may be increased.
If treatment is continued, caution should be observed with the use of certain anaesthetic drugs. In a patient under beta-blockade, the anaesthetic selected should be one exhibiting as little negative inotropic activity as possible (halothane/nitrous oxide).
The patient may be protected against vagal reactions by intravenous administration of atropine. Patients with anamnestically known psoriasis should take beta-blockers only after careful consideration. In patients with significant hepatic dysfunction it may be necessary to adjust the dosage because metoprolol undergoes biotransformation in the liver.
Beta-blockers mask some of the clinical signs of thyrotoxicosis. Therefore, metoprolol should be administered with caution to patients having, or suspected of developing, thyrotoxicosis, and both thyroid and cardiac function should be monitored closely.
The full oculomucocutaneous syndrome, as described elsewhere […]
During acute intervention in myocardial infarction, intravenous metoprolol should only be used by experienced staff under circumstances where resuscitation and monitoring equipment is available.
Cardiac Failure:
Depression of the myocardium with METOPROLOL may lead to cardiac failure (see general Warnings above). Special caution should be exercised when administering METOPROLOL to patients with a history of cardiac failure or those with minimal cardiac reserve.
Should failure occur, treatment should be as described in WARNINGS.
Severe Sinus Bradycardia:
Severe sinus bradycardia may occur with METOPROLOL use (see general Warnings above). Acute myocardial infarction (particularly inferior infarcts) may significantly decrease sinus rate. 5 mg) intravenously. If atropine treatment is unsuccessful, discontinue METOPROLOL and consider cautious administration of isoproterenol or installation of a cardiac pacemaker.
24 sec), second-, or third-degree heart block. Acute myocardial infarction may also produce heart block. 5 mg) intravenously. If atropine treatment is unsuccessful, consider cautious administration of isoproterenol or installation of a cardiac pacemaker.
Because of their negative effect on atrioventricular conduction, beta-blockers, including METOPROLOL, should only be given with caution to patients with first degree atrioventricular block.
Hypotension:
If hypotension (systolic blood pressure ≤ 90 mmHg) occurs, METOPROLOL should be discontinued, and the hemodynamic status of the patient and the extent of myocardial ischemia carefully assessed. Invasive monitoring of central venous, pulmonary capillary wedge, and arterial pressures may be required.
Appropriate therapy with fluids, positive inotropic agents, balloon counterpulsation, or other treatment modalities should be instituted. If hypotension is associated with sinus bradycardia or A-V block, treatment should be directed at reversing these (see above).
Abrupt withdrawal Patients with angina or hypertension should be warned against abrupt discontinuation of METOPROLOL. There have been reports of severe exacerbation of angina, and of myocardial infarction or ventricular arrhythmias occurring in patients with angina pectoris, following abrupt discontinuation of β-blocker therapy.
The last two complications may occur with or without preceding exacerbation of angina pectoris. Therefore, when discontinuation of METOPROLOL is planned in patients with angina pectoris or previous myocardial infarction, the dosage should be gradually reduced over a period of about two weeks.
The patient should be carefully observed. The same frequency of administration should be maintained. In situations of greater urgency, metoprolol tartrate therapy should be discontinued stepwise and with closer observation. If angina markedly worsens or acute coronary insufficiency develops, it is recommended that treatment with METOPROLOL be reinstituted promptly, at least temporarily.
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 is prudent not to discontinue METOPROLOL therapy abruptly even in patients treated only for hypertension.
Endocrine and Metabolism Thyrotoxicosis:
Although metoprolol has been used successfully for the symptomatic (adjuvant) therapy of thyrotoxicosis, possible deleterious effects from long-term use of metoprolol tartrate have not been adequately appraised. β-blockade may mask the clinical signs of […]