Tolol-XR is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. A lower blood pressure can reduce the risk of strokes and heart attacks.
Tolol-XR is also used to treat severe chest pain (angina) and lowers the risk of repeated heart attacks. It is given to people who have already had a heart attack. In addition, Tolol-XR is used to treat patients with heart failure.
Tolol-XR is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.
Tolol-XR is available only with your doctor's prescription.
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.
Tolol-XR 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 Tolol-XR.
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 (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Tolol-XR may be administered with other antihypertensive agents.
Tolol-XR is indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
Tolol-XR 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, Tolol-XR decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
How should I use Tolol-XR?
Use Tolol-XR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Tolol-XR is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Tolol-XR at home, a health care provider will teach you how to use it. Be sure you understand how to use Tolol-XR. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Tolol-XR if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Tolol-XR, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Tolol-XR.
Uses of Tolol-XR 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 Tolol-XR 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 Tolol-XR, 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, Tolol-XR) 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, Tolol-XR) 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 Tolol-XR 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, Tolol-XR 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 Tolol-XR, 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 Tolol-XR is recommended for acute treatment in hemodynamically stable patients and oral Tolol-XR 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 Tolol-XR 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 Tolol-XR, 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.
Tolol-XR is a cardioselective β1-adrenergic blocking agent used for acute myocardial infarction (MI), heart failure, angina pectoris and mild to moderate hypertension. It may also be used for supraventricular and tachyarrhythmias and prophylaxis for migraine headaches. Tolol-XR is structurally similar to bisoprolol, acebutolol and atenolol in that it has two substituents in the para position of the benzene ring. The β1-selectivity of these agents is thought to be due in part to the large substituents in the para position. At low doses, Tolol-XR selectively blocks cardiac β1-adrenergic receptors with little activity against β2-adrenergic receptors of the lungs and vascular smooth muscle. Receptor selectivity decreases with higher doses. Unlike propranolol and pindolol, Tolol-XR does not exhibit membrane-stabilizing or intrinsic sympathomimetic activity. Membrane-stabilizing effects are only observed at doses much higher than those needed for β-adrenergic blocking activity. Tolol-XR possesses a single chiral centre and is administered as a racemic mixture.
Generic name: Tolol-XR SUCCINATE 25mg
Dosage form: tablet, extended release
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Tolol-XR is an extended-release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release Tolol-XR to Tolol-XR, use the same total daily dose of Tolol-XR. Individualize the dosage of Tolol-XR. Titration may be needed in some patients.
Tolol-XR tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.
Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. The dosage may be increased 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.
Pediatric Hypertensive Patients ≥ 6 Years of age: A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP); however, some other endpoints demonstrated effectiveness. If selected for treatment, the recommended starting dose of Tolol-XR is 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Dosage should be adjusted 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.
Tolol-XR is not recommended in pediatric patients < 6 years of age.
Individualize the dosage of Tolol-XR. 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 - 2 weeks.
Dosage must be individualized and closely monitored during up-titration. Prior to initiation of Tolol-XR, stabilize the dose of other heart failure drug therapy. The recommended starting dose of Tolol-XR is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 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 Tolol-XR. Initial difficulty with titration should not preclude later attempts to introduce Tolol-XR. If patients experience symptomatic bradycardia, reduce the dose of Tolol-XR. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of Tolol-XR or temporarily discontinuing it. The dose of Tolol-XR should not be increased until symptoms of worsening heart failure have been stabilized.
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Tolol-XR extended-release tablets
Tolol-XR (Advanced Reading)
Other brands: Tolol-XR, Tolol-XR Succinate ER, Lopressor
Tolol-XR is a CYP2D6 substrate. Drugs that inhibit CYP2D6 can have an effect on the plasma concentration of Tolol-XR. Examples of drugs that inhibit CYP2D6 are quinidine, terbinafine, paroxetine, fluoxetine, sertraline, celecoxib, propafenon and diphenhydramine. When treatment with these drugs are initiated, the dose of Tolol-XR might have to be reduced for patients treated with Tolol-XR.
The Following Combinations with Tolol-XR Should be Avoided:Barbituric Acid Derivatives: Barbiturates (investigated for pentobarbital) induce the metabolism of Tolol-XR by enzyme induction.
Propafenone: Upon administration of propafenone to 4 patients on Tolol-XR therapy, the plasma concentrations of Tolol-XR increased by 2-5 fold and 2 patients experienced side effects typical of Tolol-XR. The interaction was confirmed in 8 healthy volunteers. The interaction is probably explained by the fact that propafenone, similarly to quinidine, inhibits the metabolism of Tolol-XR via cytochrome P450 2D6. The combination is probably difficult to handle since propafenone also has beta-receptor blocking properties.
Verapamil: In combination with beta-receptor blocking drugs (described for atenolol, propranolol and pindolol), verapamil may cause bradycardia and fall in blood pressure.
Verapamil and beta-blockers have additive inhibitory effects on AV-conduction and sinusnode function.
The Following Combinations with Tolol-XR may require Modified Drug
Amiodarone: A case report suggests that patients treated with amiodarone may developed pronounced sinus bradycardia when treated simultaneously with Tolol-XR. Amiodarone has extremely long half-life (around 50 days), which implies that interactions can occur for a long time after withdrawal of the drug.
Antiarrhythmics, Class I: Class I antiarrhythmics and beta-receptor blocking drugs have additive negative inotropic effects which may result in serious haemodynamic side effects in patients with impaired left ventricular function. The combination should also be avoided in "sick sinus syndrome" and pathological AV-conduction. The interaction is best documented for disopyramide.
Nonsteroidal Anti-Inflammatory/Antirheumatic Drugs (NSAIDs): NSAID-antiphlogistics have been shown to counteract the antihypertensive effect of beta-receptor blocking drugs. Primarily, indomethacin has been studied. This interaction probably does not occur with sulindac. A negative interaction study on diclofenac has been performed.
Diphenhydramine: Diphenhydramine decreases (2.5 times) clearance of Tolol-XR to alpha-hydroximetoprolol via CYP2D6 in fast hydroxylating persons. The effects of Tolol-XR are enhanced. Diphenhydramine may probably inhibit the metabolism of other CYP2D6 substrates.
Digitalis Glycosides: Digitalis glycosides in association with beta-blockers, may increase AV conduction time and may induce bradycardia.
Diltiazem: Diltiazem and beta-receptor blockers have additive inhibitory effects on the AV-conduction and sinusnode function. Pronounced bradycardia has been observed (case reports) during combination treatment with diltiazem.
Epinephrine: There are about 10 reports on patients treated with nonselective beta-receptor blockers (including pindolol and propranolol) that developed pronounced hypertension and bradycardia after administration of epinephrine (adrenaline). These clinical observations have been confirmed in studies in healthy volunteers. It has also been suggested that epinephrine in local anaesthetics may provoke these reactions upon intravasal administration. The risk is probably less with cardioselective beta-receptor blockers.
Phenylpropanolamine: Phenylpropanolamine (norephedrine) in single doses of 50 mg may increase the diastolic blood pressure to pathological values in healthy volunteers. Propranolol generally counteracts the rise in blood pressure induced by phenylpropanolamine. However, beta-receptor blockers may provoke paradoxical hypertensive reactions in patients who take high doses of phenylpropranolamine. Hypertensive crisis during treatment with only phenylpropanolamine have been described in a couple of cases.
Quinidine: Quinidine inhibits the metabolism of Tolol-XR in so-called rapid hydroxylators (>90% in Sweden) with markedly elevated plasma levels and enhanced beta-blockade as a result. A corresponding interaction might occur with other beta-blockers metabolised by the same enzyme (cytochrome P450 2D6).
Clonidine: The hypertensive reaction when clonidine is suddenly withdrawn may be potentiated by beta-blockers. If concomitant treatment with clonidine is to be discontinued, the beta-blocker medication should be withdrawn several days before clonidine.
Rifampicin: Rifampicin may induce the metabolism of Tolol-XR resulting in decreased plasma levels.
Patients receiving concomitant treatment with other beta-blockers (ie, eye drops) or MAO Inhibitors should be kept under close surveillance. In patients receiving beta-receptor blocker therapy, inhalation anaesthetics enhance the cardio-depressant effect. The dosages of oral antidiabetics may have to be readjusted in patients receiving beta-blockers. The plasma concentration of Tolol-XR can increase when cimetidine or hydralazine are administered simultaneously.
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 Tolol-XR succinate in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of Tolol-XR succinate patients discontinued for adverse events 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 Tolol-XR succinate 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 Tolol-XR Succinate Group and Greater Than Placebo by More Than 0.5%
n = 1990 % of patients
n = 2001 % of patients
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, Tolol-XR succinate 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Tolol-XR succinate 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% 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 extended-release Tolol-XR or immediate-release Tolol-XR. 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 Tolol-XR 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.
You should not use this medication if you are allergic to Tolol-XR, or if you have a serious heart problem such as heart block, sick sinus syndrome, or slow heart rate.
Before taking Tolol-XR, tell your doctor if you have congestive heart failure, low blood pressure, circulation problems, pheochromocytoma, asthma or other breathing problems, diabetes, depression, liver or kidney disease, a thyroid disorder, or severe allergies.
Tolol-XR may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase certain side effects of Tolol-XR.
Do not stop taking Tolol-XR without first talking to your doctor. Stopping suddenly may make your condition worse.
If you need surgery, tell the surgeon ahead of time that you are using Tolol-XR.
Tolol-XR is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
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).
The results of a survey conducted on ndrugs.com for Tolol-XR are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tolol-XR. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
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1 consumer reported time for results
To what extent do I have to use Tolol-XR before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes > 3 month and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Tolol-XR. To get the time effectiveness of using Tolol-XR drug by other patients, please click here.
> 3 month
1 consumer reported age
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