Treating high blood pressure, alone or with other medicines; long-term treatment of chest pain; and treating certain types of heart failure. It may also be used for other conditions as determined by your doctor.
Metoprolol Succinate extended-release tablets is a beta-adrenergic blocking agent (beta-blocker). It works by reducing the amount of work the heart has to do (reduces chest pain) and the amount of blood the heart pumps out (lowers high blood pressure). It is also used to stabilize the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm.
Metoprolol Succinate indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Metoprolol Succinate is 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 Succinate.
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. 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.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Metoprolol Succinate extended-release tablet may be administered with other antihypertensive agents.
Metoprolol Succinate extended-release tablet is indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
Metoprolol Succinate extended-release tablet is indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, Metoprolol Succinate extended-release tablet decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
How should I use Metoprolol Succinate?
Use Metoprolol Succinate extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Metoprolol Succinate extended-release tablets by mouth either always with food or immediately following a meal, at the same time each day.
Metoprolol Succinate extended-release tablets may be broken in half. Swallow the tablets or half tablets whole. Do not crush or chew before swallowing.
If you miss a dose of Metoprolol Succinate extended-release tablets, take it if you remember the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, check with your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Metoprolol Succinate extended-release tablets.
Uses of Metoprolol Succinate in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Angina: Long-term treatment of angina pectoris.
Heart failure with reduced ejection fraction (ER oral formulation): Treatment of stable, symptomatic (NYHA class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin to reduce the rate of mortality plus hospitalization in patients already receiving angiotensin-converting enzyme inhibitors, diuretics, and/or digoxin.
Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2017]).
Myocardial infarction: Treatment of hemodynamically stable acute myocardial infarction to reduce cardiovascular mortality (injection to be used in combination with Metoprolol Succinate oral maintenance therapy).
Off Label Uses
Based on the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for the management of patients with atrial fibrillation (AF), the use of beta-blockers, including Metoprolol Succinate, for ventricular rate control in patients with paroxysmal, persistent, or permanent AF is effective and recommended.
Atrial fibrillation prevention after cardiac surgery
Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for coronary artery bypass graft surgery, beta-blockers are recommended to help prevent postoperative atrial fibrillation.
Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for the diagnosis and treatment of hypertrophic cardiomyopathy, a beta blocker (eg, Metoprolol Succinate) is an effective and recommended agent for the treatment of symptoms (eg, angina, dyspnea) in patients with obstructive or nonobstructive hypertrophic cardiomyopathy.
Marfan syndrome with aortic aneurysm
Based on the American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery (ACCF/AHA/AATS) guideline for the diagnosis and management of patients with thoracic aortic disease, a beta blocker (eg, Metoprolol Succinate) is an effective and recommended agent to reduce the rate of aortic dilatation in patients with Marfan syndrome and aortic aneurysm, unless a contraindication exists.
Data from small, randomized, active-controlled trials support the use of Metoprolol Succinate for prevention of migraines.
Based on evidence-based guidelines for pharmacologic treatment for episodic migraine prevention in adults from the American Academy of Neurology and the American Headache Society, Metoprolol Succinate is effective for migraine prevention in adults.
Based on the American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guidelines for the management of adult patients with supraventricular tachycardia, the use of an oral or intravenous beta-blocker, including Metoprolol Succinate, is effective and recommended for a variety of symptomatic supraventricular tachycardias (atrioventricular nodal reentrant tachycardia [AVNRT], atrioventricular reentrant tachycardia [AVRT], focal atrial tachycardia [AT], and multifocal atrial tachycardia [MAT]). In patients without pre-excitation, intravenous Metoprolol Succinate is recommended for acute treatment in hemodynamically stable patients and oral Metoprolol Succinate is recommended for ongoing management of symptomatic supraventricular tachycardias in patients who are not candidates for, or prefer not to undergo, catheter ablation.
Intravenous or oral Metoprolol Succinate may be useful for rate control in the acute treatment or ongoing management of hemodynamically stable patients with atrial flutter.
Based on the American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, beta-blockers, including Metoprolol Succinate, are effective and recommended in the treatment of symptomatic thyrotoxicosis. Beta-blockers should also be considered in asymptomatic patients who are at increased risk of complications due to worsening hyperthyroidism.
Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for management of patients with ventricular arrhythmias and prevention of sudden cardiac death, beta-blockers are effective for control of ventricular arrhythmias and ventricular premature beats.
Metoprolol Succinate description
Each tablet contains Metoprolol Succinate 11.875, 23.75, 47.5 or 95 mg, equivalent to Metoprolol Succinate tartrate 12.5, 25, 50 and 100 mg, respectively.
Metoprolol Succinate dosage
Adults: The usual initial dosage is 25 mg to 100 mg once daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied.
Pediatric Hypertensive Patients 6 Years of age or older: The recommended starting dose of Metoprolol Succinate Sprinkle is 1 mg/kg once daily, the maximum initial dose should not exceed 50 mg once daily. Adjust dosage according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients.
Metoprolol Succinate Sprinkle has not been studied in pediatric patients less than 6 years of age.
Individualize the dosage of Metoprolol Succinate Sprinkle. The usual initial dosage is 100 mg once 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.
Prior to initiation of Metoprolol Succinate Sprinkle, stabilize the dose of other heart failure drug therapy and ensure that the patient is not fluid overloaded. The recommended starting dose of Metoprolol Succinate Sprinkle is 25 mg once daily for two weeks. Metoprolol Succinate Sprinkle is not suitable for initial therapy in patients who are expected to require a starting dose less than 25 mg daily. Dosage must be individualized and closely monitored during up-titration. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of Metoprolol Succinate Sprinkle. If a patient experiences symptomatic bradycardia, reduce the dose of Metoprolol Succinate Sprinkle. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of Metoprolol Succinate Sprinkle or temporarily discontinuing it. The dose of Metoprolol Succinate Sprinkle should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce Metoprolol Succinate Sprinkle.
For patients who are taking Metoprolol Succinate extended-release tablets at a dose of 25 mg to 200 mg once daily, substitute Metoprolol Succinate Sprinkle for Metoprolol Succinate extended-release tablets, using the same total daily dose of Metoprolol Succinate.
Metoprolol Succinate Sprinkle should be swallowed whole. For patients unable to swallow an intact capsule, alternative administration options are available.
Directions for use with soft food (applesauce, pudding, or yogurt)
For patients with swallowing difficulty, Metoprolol Succinate Sprinkle can be opened and contents can be sprinkled over soft food. The contents of the capsules should be swallowed along with a small amount (teaspoonful) of soft food (such as applesauce, pudding, or yogurt). The drug/food mixture should be swallowed within 60 minutes and not stored for future use.
Nasogastric tube administration
Open and add contents of capsule to an all plastic oral tip syringe and add 15 mL of water. Gently shake the syringe for approximately 10 seconds. Promptly deliver through a 12 French or larger nasogastric tube. Ensure no granules are left in the syringe. Rinse with additional water if needed.
Catecholamine depleting drugs (eg, reserpine, MAOIs) may have an additive effect when given with β-blocking agents. Patients treated with Metoprolol Succinate plus a catecholamine depletor should therefore be closely observed for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope or postural hypotension.
The effects of Metoprolol Succinate and other drugs with an antihypertensive effect on blood pressure are usually additive and care should be taken to avoid hypotension eg, could be the result of concomitant administration with dihydropyridine derivatives, tricyclic antidepressant, barbiturates and phenothiazines. However, combinations of antihypertensive drugs may often be used with benefit to improve control of hypertension.
Metoprolol Succinate can reduce myocardial contractility and impair intracardiac conduction. Care should be exercised when drugs with similar activity eg, antiarrhythmic agents, general anesthetics, are given concurrently. Like all other β-blockers, Metoprolol Succinate should not be given in combination with verapamil, diltiazem or digitalis glycosides. Caution is advised when Metoprolol Succinate is given in combination with calcium antagonists, since this may cause bradycardia, hypotension and asystole. Care should also be exercised when β-blockers are given in combination with sympathetic ganglion blocking agents, other β-blockers (ie, eye drops).
Drugs that inhibit CYP2D6 eg, quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol Succinate concentration. In healthy subjects with CYP2D6, extensive metabolizer phenotype, co-administration of quinidine 100 mg and immediate-release Metoprolol Succinate 200 mg tripled the concentration of S-Metoprolol Succinate and doubled the Metoprolol Succinate elimination t½. In 4 patients with cardiovascular disease, co-administration of propafenone 150 mg thrice daily with immediate-release Metoprolol Succinate 50 mg thrice daily resulted in 2- to 5-fold increases in the steady-state concentration of Metoprolol Succinate. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol Succinate.
If concomitant treatment with clonidine is to be discontinued, Metoprolol Succinate should be withdrawn several days before clonidine.
As β-blockers may affect the peripheral circulation, care should be exercised when drugs with similar activity eg, ergotamine are given concurrently.
Metoprolol Succinate will antagonise the β1 effects of sympathomimetic agents but should have little influence on the bronchodilator effects of β2-agonists at normal therapeutic doses. Enzyme inducing agents (eg, rifampicin) may reduce plasma concentrations of Metoprolol Succinate, whereas enzyme inhibitors (eg, cimetidine, alcohol and hydralazine) may increase plasma concentrations. Metoprolol Succinate may impair the elimination of lidocaine (lignocaine).
The dosages of oral antidiabetic agents and also of insulin may have to be readjusted in patients receiving β-blockers. Concomitant treatment with indomethacin and other prostaglandin synthetase inhibiting drugs may reduce the antihypertensive effect of β-blockers.
The following adverse reactions are described elsewhere in labeling:
Worsening angina or myocardial infarction.
Worsening heart failure.
Worsening AV block.
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.
Heart Failure: In the MERIT-HF study comparing Metoprolol Succinate extended-release tablets in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of Metoprolol Succinate extended-release tablet patients discontinued for adverse reactions vs. 12.2% of placebo patients.
The table below lists adverse reactions in the MERIT-HF study that occurred at an incidence of ≥ 1% in the Metoprolol Succinate extended-release tablet group and greater than placebo by more than 0.5%, regardless of the assessment of causality.
Adverse Reactions Occurring in the MERIT-HF Study at an Incidence ≥ 1 % in the Metoprolol Succinate Extended-Release Tablet Group and Greater Than Placebo by More Than 0.5 %
Metoprolol Succinate Extended-release Tablets
n=1990 % of patients
n=2001 % of patients
Accident and/or injury
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 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol Succinate extended-release use was associated with a higher incidence of bradycardia (6.6% vs. 2.4%; HR 2.74; 95% CI 2.19, 3.43), hypotension (15% vs. 9.7%; HR 1.55; 95% CI 1.37, 1.74), stroke (1.0% vs. 0.5%; HR 2.17; 95% CI 1.26, 3.74) and death (3.1% vs. 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.
The following adverse reactions have been identified during post-approval use of Metoprolol Succinate or immediate-release Metoprolol Succinate. 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.
Potential Adverse Reactions: 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.
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.
DailyMed. "METOPROLOL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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