Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include difficult or slowed breathing; fainting; severe dizziness; very slow heart rate; weakness.
Proper storage of Topol XL tartrate:
Store Topol XL tartrate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Topol XL tartrate out of the reach of children and away from pets.
Overdose of Topol XL in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Signs and Symptoms - Overdosage of Topol XL Succinate extended-release tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block, heart failure, bronchospasm, hypoxia, impairment of consciousness/coma, nausea and vomiting.
Treatment - Consider treating the patient with intensive care. Patients with myocardial infarction or heart failure may be prone to significant hemodynamic instability. Seek consultation with a regional poison control center and a medical toxicologist as needed. Beta-blocker overdose may result in significant resistance to resuscitation with adrenergic agents, including beta-agonists. On the basis of the pharmacologic actions of Topol XL, employ the following measures.
There is very limited experience with the use of hemodialysis to remove Topol XL, however Topol XL is not highly protein bound.
Bradycardia: Evaluate the need for atropine, adrenergic-stimulating drugs or pacemaker to treat bradycardia and conduction disorders.
Hypotension: Treat underlying bradycardia. Consider intravenous vasopressor infusion, such as dopamine or norepinephrine.
Heart failure and shock: May be treated when appropriate with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenergic drugs such as dobutamine, with α1 receptor agonistic drugs added in presence of vasodilation.
Bronchospasm: Can usually be reversed by bronchodilators.
What should I avoid while taking Topol XL?
Avoid driving or hazardous activity until you know how Topol XL will affect you. Your reactions could be impaired.
Drinking alcohol can increase certain side effects of Topol XL.
Topol XL warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Beta blockers, like Topol XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Topol XL or to discontinue it.
Ischemic Heart Disease
Do not abruptly discontinue Topol XL therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Topol XL, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Topol XL administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. 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 may be prudent not to discontinue Topol XL therapy abruptly even in patients treated only for hypertension.
Use During Major Surgery
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.
Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Topol XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Topol XL. If severe bradycardia develops, reduce or stop Topol XL.
Exacerbation of Bronchospastic Disease
Patients with bronchospastic disease, should, in general, not receive beta blockers, including Topol XL. Because of its relative beta1 selectivity, however, Topol XL may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of Topol XL and consider administering Topol XL in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval. Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly.
Diabetes and Hypoglycemia
Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
If Topol XL 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. 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.
Topol XL may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.
What should I discuss with my healthcare provider before taking Topol XL?
Some medical conditions may interact with Topol XL tartrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have an adrenal gland tumor (pheochromocytoma), an overactive thyroid, or are scheduled to have surgery
if you have low blood pressure or a history of heart attack, slow or irregular heartbeat, heart failure, or other heart problems; chest pain or angina; blood circulation problems; or liver problems
if you have diabetes mellitus, chronic obstructive pulmonary disease (COPD), bronchitis, breathing problems, or a history of asthma
Some MEDICINES MAY INTERACT with Topol XL tartrate. Tell your health care provider if you are taking any other medicines, especially any of the following:
Amiodarone, bupropion, cimetidine, digoxin, diltiazem, diphenhydramine, disopyramide, flecainide, certain HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), hydralazine, hydroxychloroquine, ketanserin, mefloquine, mibefradil, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), propafenone, propylthiouracil, quinazolines (eg, alfuzosin), quinidine, reserpine, certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), terbinafine, or verapamil because serious side effects, such as very slow heart rate, very low blood pressure, fainting, severe dizziness, or lightheadedness when standing, may occur
Clonidine because stopping it or Topol XL tartrate suddenly can lead to a rapid increase in blood pressure
Barbiturates (eg, phenobarbital), indomethacin, or phenylpropanolamine because they may decrease Topol XL tartrate's effectiveness
Bupivacaine, disopyramide, flecainide, hydralazine, ketanserin, or lidocaine because the risk of their side effects may be increased by Topol XL tartrate
This may not be a complete list of all interactions that may occur. Ask your health care provider if Topol XL tartrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Topol XL precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
IV administration of calcium antagonists of the verapamil-type should not be given to patients treated with β-blockers.
Generally, when treating patients with asthma, concomitant therapy with a β2-agonist (tablet and/or aerosol) should be administered. The dosage of β2-agonists may require adjustment (increase) when treatment with S-Topol XL is started. The risk of S-Topol XL interfering with β2-receptors is however, less than with conventional tablet formulations of β1-selective blockers.
During treatment with S-Topol XL, the risk of interfering with carbohydrate metabolism or masking hypoglycemia is likely to be less than during treatment with conventional tablet formulations of β1-selective blockers and much less than with nonselective β-blockers.
Patients suffering from heart failure should have their decompensation treated both before and during treatment.
Very rarely, a preexisting AV conduction disorder of moderate degree may become aggravated (possibly leading to AV block).
If the patients develop increasing bradycardia, S-Topol XL should be given in lower doses or gradually withdrawn.
S-Topol XL may aggravate the symptoms of peripheral arterial circulatory disorders, mainly due to its blood pressure lowering effect.
Where S-Topol XL is prescribed for a patient known to be suffering from a phaeochromocytoma, an α-blocker should be given concomitantly.
Prior to surgery, the anesthetist should be informed that the patient is receiving S-Topol XL. It is not recommended to stop β-blocker treatment in patients undergoing surgery.
Abrupt interruption of Topol XL is to be avoided. Sudden withdrawal of β-blockade is hazardous, especially in high-risk patients, and may aggravate angina pectoris as well as increase the risk of myocardial infarction and sudden death. Any withdrawal of S-Topol XL should therefore, if possible, be made gradually over at least 2 weeks when the dose is reduced by ½ in each step, down to the final dose when a 25-mg tablet is reduced to ½ tablet. The final dose should be given for at least 4 days before discontinuation. If symptoms occur, a slower withdrawal rate is recommended.
Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies of Topol XL or S-Topol XL in pregnant women. Because animal reproduction studies are not always predictive of human response, use S-Topol XL during pregnancy only if clearly needed.
Use in lactation: Racemic Topol XL was reported to be excreted in breast milk in very small quantities. An infant consuming 1 L of breast milk daily would receive a dose of <1 mg of Topol XL. Possible infant exposure must be considered when Topol XL/S-Topol XL is administered to a nursing woman.
Use in children: Safety and effectiveness of S-Topol XL has not been established in children; hence S-Topol XL is not recommended for use in this population.
What happens if I miss a dose of Topol XL?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
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).