Metoprolol is an active pharmaceutical ingredient in the Beta Blocking Agents, Selective group (C07AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
USOfficial regulatory label· revised June 10, 2025[1]
1 INDICATIONS AND USAGE Metoprolol tartrate 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. 2 ) Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients.
1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, 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 March 27, 2026[2]
In the management of: • Hypertension • Angina pectoris • Cardiac arrhythmias (in particular supraventricular tachycardias) • As an adjunctive treatment of thyrotoxicosis. • Early intervention of metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation.
Pain relief may also decrease the need for opiate analgesics. • long-term prophylaxis after recovery from acute myocardial infarction. • Prophylaxis of migraine. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction Metoprolol is indicated in adults.
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 · 00de1f16-f979-4d… · revised June 10, 2025 [PDF]
[2]MHRA (UK) · PL282780039 · revised March 27, 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 tartrate tablets may be administered with other antihypertensive agents. 2 Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
3 Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol.
How to take
USOfficial regulatory label· revised June 10, 2025[1]
2 DOSAGE AND ADMINISTRATION Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. 1 ) Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses.
2 ) Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. 1 Hypertension Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage is 100 mg daily in single or divided doses. 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.
The effective dosage range of metoprolol tartrate tablets is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period.
Larger or more frequent daily doses may be required. Measure blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. 2 Angina Pectoris The dosage of metoprolol tartrate tablets should be individualized.
Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate.
The effective dosage range of metoprolol tartrate tablets is 100 to 400 mg per day. Dosages above 400 mg per day have not been studied. 1) ]. 3 Myocardial Infarction See prescribing information of intravenous metoprolol for dosage instructions for intravenous therapy.
In patients who tolerate the full intravenous dose, initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose of metoprolol and continue for 48 hours. In the case of intolerance, reduce dose to 25 mg and administer for 48 hours.
Titrate, based on tolerability, to a maintenance dosage of 100 mg twice daily. Continue therapy for at least 3 months. Although the efficacy of metoprolol tartrate tablets beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.
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 June 10, 2025[1]
6 ADVERSE REACTIONS 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) ].
Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. gov/medwatch. 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.
Hypertension and Angina Most adverse effects have been mild and transient.
Central Nervous System:
Tiredness and dizziness have occurred in about 10% of patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported.
Cardiovascular:
Shortness of breath and bradycardia have occurred in approximately 3% of patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; heart failure exacerbations; peripheral edema; and hypotension have been reported in about 1% of patients.
Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported. 2) ]. 3) ] . Rhinitis has also been reported.
Gastrointestinal:
Diarrhea has occurred in about 5% of patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1% of patients. Vomiting was a common occurrence.
Hypersensitive Reactions:
Pruritus or rash have occurred in about 5% of patients. Photosensitivity and worsening of psoriasis has been reported.
Miscellaneous:
Peyronie’s disease, musculoskeletal pain, blurred vision, and tinnitus has been reported. Myocardial Infarction In general, the adverse reactions observed in trials with metoprolol in MI are consistent with the hypertension and angina experience.
2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of 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.
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, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular:
Intensification of AV block [see Contraindications (4) ].
Hematologic:
Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura.
Hypersensitive Reactions:
Fever combined with aching and sore throat, laryngospasm and respiratory distress.
Laboratory Findings :
Increase in blood triglycerides, elevated transaminase and decrease in High Density Lipoprotein (HDL)
USOfficial regulatory label· Warnings and precautions· revised June 10, 2025[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 ) Pheochromocytoma: Initiate therapy with an alpha blocker.
4 ) 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. 6 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.
7 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. 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, 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, 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 in patients treated only for hypertension. 2 Heart Failure Worsening cardiac failure may occur during up-titration of metoprolol.
If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol [see Dosage and Administration (2) ]. It may be necessary to lower the dose of metoprolol or temporarily discontinue it.
Such episodes do not preclude subsequent successful titration of metoprolol. 3 Bronchospastic Disease Patients with bronchospastic disease, should in general, not receive beta-blockers, including metoprolol. Because of its relative beta 1 cardio-selectivity, however, metoprolol 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. Bronchodilators, including beta 2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2) ]. 4 Pheochromocytoma If metoprolol is 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised June 10, 2025[1]
4 CONTRAINDICATIONS Metoprolol tartrate tablets are contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, systolic blood pressure <100, 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.
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 )
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised March 27, 2026[2]
Posology The following dosage regimes are intended only as a guideline and should always be adjusted to the individual requirements of the patient but should not exceed 400 mg/day.
Adults:
Hypertension: Initially 100 mg daily. This may be increased, if necessary to 200 mg daily in single or divided doses. Combination therapy with a diuretic or vasodilator may also be considered to further reduce blood pressure. Metoprolol 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 added into the regime with adjustment of the previous therapy if necessary.
Angina pectoris:
Usually 50-100 mg two or three times daily. In general a significant improvement in exercise tolerance and reduction of angina 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. Following the treatment of an acute arrhythmia with metoprolol tartrate injection, continuation therapy with metoprolol tablets should be initiated 4-6 hours later.
The initial oral dose should not exceed 50mg twice daily.
Myocardial Infarction:
Early intervention: Orally, therapy should commence 15 minutes after the last intravenous injection with 50 mg every 6 hours for 48 hours and preferably within 12 hours of the onset of chest pain. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose.
Maintenance:
The usual maintenance dose is 200mg daily given in divided doses. The treatment should be continued for at least 3 months. Thyrotoxicosis 50mg four times daily. Dose should be reduced progressively as euthyroid state is achieved. Prophylaxis of migraine: 100-200mg daily in divided doses (morning and evening).
Elderly 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 elderly patients. However, caution is indicated in elderly patients as an excessive decrease in blood pressure or pulse rate may cause the blood supply to vital organs to fall to inadequate levels.
Dosage should be reduced in the elderly where there is impairment of hepatic function. Paediatric population The safety and efficacy of Metoprolol in children has not been established. Metoprolol tartrate is not recommended in children Hepatic impairment In patients with significant hepatic dysfunction dosage reduction may be advised.
Renal impairment Dose adjustment is not warranted in renal impairment. Method of Administration For oral administration.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 27, 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 available data) System Organ Class Very common (≥ 1/10) Commo n (≥ 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) Blood and lymphatic system disorders Thrombocytope nia, agranulocytosis Psychiatric disorders .
Depression, nightmares, Nervousness , anxiety, impotence Hallucinations, personality disorder, Amnesia/ memory impairment Nervous system disorders Dizzines s, headache Alertness decrease, somnolence System Organ Class Very common (≥ 1/10) Commo n (≥ 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) .
or insomnia paraesthesia. g. g. hypoacusis or deafness) Cardiac disorders Bradycar dia Heart failure, cardiac arrhythmia, palpitations. Cardiac conduction disorder, precordial pain. Increase in existing intermitte nt claudicati on Vascular disorders Orthostat ic hypotens ion, occasion ally with syncope.
Oedema, Raynaud's syndrome. Gangrene in patients with pre-existing severe peripheral circulatorydisor ders Respiratory, thoracic and mediastinal disorders Exertion al dyspnoea . Bronchospas ms (which may occur in patients without a history of obstructive lung disease) Rhinitis Gastrointestinal disorders Nausea and vomiting.
abdomin al pain Diarrhoea or constipation Dry mouth Retroperit oneal fibrosis * Hepatobiliary disorders Hepatitis Skin and subcutaneous tissue disorders Skin rash (in the form of urticaria, psoriasiform and dystrophic Photosensitivity, hyperhidrosis,al opecia, worsening of psoriasis Occurrenc e of antinuclea rantibodie s (not associated System Organ Class Very common (≥ 1/10) Commo n (≥ 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) skin lesions), with SLE) Musculoskeletal and connective tissue disorders Muscle cramps Arthritis Reproductive system and breast disorders Disturbances of libido and potency Peyronie's disease * General disorders and administration site conditions Fatigue Dysgeusia (Taste disturbances) Investigations Weight increase, liver function test abnormal * (relationship to Metoprolol has not been definitely established).
Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 27, 2026[2]
Abrupt cessation of therapy with a beta-blocker should be avoided especially in patients with ischaemic heart disease. When possible, metoprolol should be withdrawn gradually over a period of 10 days, the doses diminishing to 25mg for the last 6 days.
If necessary, at the same time, initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop. When it has been decided to interrupt a beta-blockade in preparation for surgery, therapy should be discontinued for at least 24 hours.
Continuation of betablockade reduces the risk of arrhythmias during induction and intubation, however the risk of hypertension may be increased as well. If treatment is continued, caution should be observed with the use of certain anaesthetic drugs.
The patient may be protected against vagal reactions by intravenous administration of atropine. During its withdrawal the patient should be kept under close surveillance. Although cardioselective beta-blockers may have less effect on lung function than non-selective beta-blockers these should be avoided in patients with reversible obstructive airway disease unless there are compelling clinical reasons for their use.
Although metoprolol has proved safe in a large number of asthmatic patients, it is advisable to exercise care in the treatment of patients with chronic obstructive pulmonary disease. Therapy with a beta2-stimulant may become necessary or current therapy require adjustment.
Therefore, non selective beta blockers should not be used for these patients, and beta1-selective blockers only with the utmost care. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.
Cessation of therapy with a beta blocker should be gradual. Metoprolol Tartrate tablets may not be administered to patients with untreated congestive heart failure. The congestive heart failure needs to be brought under control first of all.
If concomitant digoxin treatment is taking place, it must be borne in mind that both medicinal products slow AV conduction and that there is therefore a risk of AV dissociation. In addition, mild cardiovascular complications may occur, manifesting as dizziness, bradycardia, and a tendency to collapse.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 27, 2026[2]
1. • Second-or-third degree atrioventricular block • Uncontrolled heart failure • Clinically relevant sinus bradycardia (< 45-50 bpm) • Sick sinus syndrome. (unless a pacemaker is in situ). • Prinzmetal's angina • Myocardial infarction complicated by significant bradycardia, first degree heart block, systolic hypotension (less than 100mmHg) and/or severe heart failure and cardiogenic shock.
• Severe peripheral arterial disease. • Asthma and history of bronchospasm • Untreated phaeochromocytoma • Metabolic acidosis. • Concomitant intravenous administration of calcium blockers of the type verapamil or diltiazem or other antiarrhythmics (such as disopyramide) is contraindicated (exception: intensive care unit).
• Hypotension • Diabetes if associated with frequent episodes of hypoglycaemia • Chronic obstructive pulmonary disease
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.
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. 5 Major Surgery Avoid initiation of a high-dose regimen of beta-blocker therapy 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 hypoglycemia occurs, patients should be instructed to seek emergency treatment. Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
7 Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm. 8 Risk of Anaphylactic Reaction While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic.
Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. 9 Peripheral Vascular Disease Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
When a beta blocker is being taken, a serious, sometimes even life-threatening deterioration in cardiac function can occur, in particular in patients in whom the action of the heart is dependent on the presence of sympathetic system support.
This is due less to an excessive beta-blocking effect and more to the fact that patients with marginal heart function tolerate poorly a reduction in sympathetic nervous system activity, even where this reduction is slight. This causes contractility to become weaker and the heart rate to reduce and slows down AV conduction.
The consequence of this can be pulmonary oedema, AV block, and shock. Occasionally, an existing AV conduction disturbance can deteriorate, which can lead to AV block. In patients with a phaeochromocytoma, an alpha blocker should be given concomitantly.
Before a patient undergoes an operation, the anaesthetist must be informed that metoprolol is being taken. Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.
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 Simultaneous administration of adrenaline (epinephrine), noradrenaline (norepinephrine) and β blockers may lead to increase in blood pressure and bradycardia.
Metoprolol may induce or aggravate bradycardia, symptoms of peripheral arterial circulatory disorders and anaphylactic shock. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.
Metoprolol may be administered when heart failure has been controlled. Digitalisation and/or diuretic therapy should also be considered for patients with a history of heart failure or patients known to have a poor cardiac reserve. Metoprolol may reduce the effect of diabetes treatment and mask the symptoms of hypoglycaemia.
The risk of a carbohydrate metabolism disorder or masking of the symptoms of hypoglycaemia is lower when using metoprolol prolonged release tablets than when using regular tablet forms for beta1 selective beta blockers and significantly lower than when using nonselective beta blockers.
In labile and insulin dependent diabetes, it may be necessary to adjust the hypoglycaemic therapy. In case of unstable or insulin-dependent diabetes mellitus, it may be necessary to adjust the hypoglycaemic treatment (because of the likelihood of severe hypoglycaemic conditions).
Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. 5). In patients with significant hepatic dysfunction it may be necessary to adjust the dosage because metoprolol undergoes biotransformation in the liver.
3). The elderly should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly. It may be necessary to use a lower strength formulation in elderly patients and patients with hepatic or renal impairment and an alternative product should be prescribed.
Patients with anamnestically known psoriasis should take beta-blockers only after careful consideration as the medicine may cause […]
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 […]