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.
Translol XL 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.
Translol XL 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.
Translol XL 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 Translol XL.
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.
Translol XL extended-release tablet may be administered with other antihypertensive agents.
Translol XL extended-release tablet is indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
Translol XL 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, Translol XL 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 Translol XL?
Use Translol XL extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Translol XL extended-release tablets by mouth either always with food or immediately following a meal, at the same time each day.
Translol XL 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 Translol XL 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 Translol XL extended-release tablets.
Uses of Translol XL 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 Translol XL 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 Translol XL, 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, Translol XL) 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, Translol XL) 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 Translol XL 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, Translol XL 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 Translol XL, 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 Translol XL is recommended for acute treatment in hemodynamically stable patients and oral Translol XL 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 Translol XL 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 Translol XL, 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.
Translol XL description
Each tablet contains metoprolol succinate 11.875, 23.75, 47.5 or 95 mg, equivalent to Translol XL tartrate 12.5, 25, 50 and 100 mg, respectively.
Translol XL 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 Translol XL 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.
Translol XL Sprinkle has not been studied in pediatric patients less than 6 years of age.
Individualize the dosage of Translol XL 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 Translol XL Sprinkle, stabilize the dose of other heart failure drug therapy and ensure that the patient is not fluid overloaded. The recommended starting dose of Translol XL Sprinkle is 25 mg once daily for two weeks. Translol XL 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 Translol XL Sprinkle. If a patient experiences symptomatic bradycardia, reduce the dose of Translol XL Sprinkle. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of Translol XL Sprinkle or temporarily discontinuing it. The dose of Translol XL 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 Translol XL Sprinkle.
For patients who are taking Translol XL extended-release tablets at a dose of 25 mg to 200 mg once daily, substitute Translol XL Sprinkle for Translol XL extended-release tablets, using the same total daily dose of Translol XL.
Translol XL 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, Translol XL 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 Translol XL 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 Translol XL 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.
Translol XL 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, Translol XL should not be given in combination with verapamil, diltiazem or digitalis glycosides. Caution is advised when Translol XL 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 Translol XL concentration. In healthy subjects with CYP2D6, extensive metabolizer phenotype, co-administration of quinidine 100 mg and immediate-release Translol XL 200 mg tripled the concentration of S-Translol XL and doubled the Translol XL elimination t½. In 4 patients with cardiovascular disease, co-administration of propafenone 150 mg thrice daily with immediate-release Translol XL 50 mg thrice daily resulted in 2- to 5-fold increases in the steady-state concentration of Translol XL. These increases in plasma concentration would decrease the cardioselectivity of Translol XL.
If concomitant treatment with clonidine is to be discontinued, Translol XL 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.
Translol XL 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 Translol XL, whereas enzyme inhibitors (eg, cimetidine, alcohol and hydralazine) may increase plasma concentrations. Translol XL 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 Translol XL 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 Translol XL 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 Translol XL 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 Translol XL Extended-Release Tablet Group and Greater Than Placebo by More Than 0.5 %
Translol XL 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, Translol XL extended-release 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Translol XL 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 Translol XL or immediate-release Translol XL. 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 Translol XL.
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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