Adverse events associated with the use of Toprol-XL may include, but are not limited to, the following:. Toprol-XL is supplied as 25mg, 50mg, mg and mg tablets designed for oral administration. The recommended initial dose of the drug is as follows:. Hypertension 25 to mg daily in a single dose, whether used alone or added to a diuretic.
The dosage may be increased at weekly or longer intervals until optimum blood pressure reduction is achieved. Dosages above mg per day have not been studied. Angina Pectoris The doseage should be individualized. The usual initial dosage is mg daily, given in a single dose. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate.
If treatment is to be discontinued, the dosage should be reduced gradually over a period of one to two weeks. Heart Failure Dosage must be individualized and closely monitored during up-titration. The dose should then be doubled every two weeks to the highest dosage level tolerated, up to mg. Hypertension A double-blind study enrolled 1, subjects with mild-to-moderate hypertension who were randomized to once daily Toprol-XL 25, , or mg , Plendil felodipine extended release tablets , a combination of the two, or placebo.
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Search Menu. Search Search Search Close. Regulatory News Service 04 October This announcement contains inside information. About Aralez Pharmaceuticals Inc. You are now leaving AstraZeneca. The bioavailability of metoprolol shows a dose-related, although not directly proportional, increase with dose and is not significantly affected by food following TOPROL-XL administration.
The pharmacokinetics of metoprolol were similar to those described previously in adults. Age, gender, race, and ideal body weight had no significant effects on metoprolol pharmacokinetics.
Long-term studies in animals have been conducted to evaluate the carcinogenic potential of metoprolol tartrate. The only histologic changes that appeared to be drug related were an increased incidence of generally mild focal accumulation of foamy macrophages in pulmonary alveoli and a slight increase in biliary hyperplasia.
There was no increase in malignant or total benign plus malignant lung tumors, nor in the overall incidence of tumors or malignant tumors. This month study was repeated in CD-1 mice, and no statistically or biologically significant differences were observed between treated and control mice of either sex for any type of tumor. In five controlled studies in normal healthy subjects, the same daily doses of TOPROL-XL and immediate-release metoprolol were compared in terms of the extent and duration of beta 1 - blockade produced.
Both formulations were given in a dose range equivalent to mg of immediate-release metoprolol per day. A sixth controlled study compared the beta 1 -blocking effects of a 50 mg daily dose of the two formulations. In each study, beta 1 -blockade was expressed as the percent change from baseline in exercise heart rate following standardized submaximal exercise tolerance tests at steady state.
TOPROL-XL administered once a day, and immediate-release metoprolol administered once to four times a day, provided comparable total beta 1 -blockade over 24 hours area under the beta 1 -blockade versus time curve in the dose range mg. For TOPROL-XL, the percent reduction in exercise heart rate was relatively stable throughout the entire dosage interval and the level of beta 1 -blockade increased with increasing doses from 50 to mg daily.
In contrast to TOPROL-XL, immediate-release metoprolol given at a dose of mg once a day produced a significantly larger peak effect on exercise tachycardia, but the effect was not evident at 24 hours. A controlled cross-over study in heart failure patients compared the plasma concentrations and beta 1 -blocking effects of 50 mg immediate-release metoprolol administered t.
A 50 mg dose of immediate-release metoprolol t. In controlled clinical studies, an immediate-release dosage form of metoprolol was an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics at dosages of mg daily.
In controlled, comparative, clinical studies, immediate-release metoprolol appeared comparable as an antihypertensive agent to propranolol, methyldopa, and thiazide-type diuretics, and affected both supine and standing blood pressure. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to drug plasma concentration, selection of proper dosage requires individual titration.
By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction, and in blood pressure, metoprolol reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris. In controlled clinical trials, an immediate-release formulation of metoprolol has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance.
The dosage used in these studies ranged from to mg daily. TOPROL-XL, in dosages of to mg once daily, has been shown to possess beta-blockade similar to conventional metoprolol tablets administered two to four times daily. The protocol excluded patients with contraindications to beta-blocker use, those expected to undergo heart surgery, and those within 28 days of myocardial infarction or unstable angina.
The primary endpoints of the trial were 1 all-cause mortality plus all-cause hospitalization time to first event and 2 all-cause mortality. Patients were stabilized on optimal concomitant therapy for heart failure, including diuretics, ACE inhibitors, cardiac glycosides, and nitrates. The mean duration of follow-up was one year. The trial also showed improvements in heart failure-related mortality and heart failure-related hospitalizations, and NYHA functional class. The table below shows the principal results for the overall study population.
The figure below illustrates principal results for a wide variety of subgroup comparisons, including US vs. The combined endpoints of all-cause mortality plus all-cause hospitalization and of mortality plus heart failure hospitalization showed consistent effects in the overall study population and the subgroups, including women and the US population.
Nonetheless, subgroup analyses can be difficult to interpret and it is not known whether these represent true differences or chance effects. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery POISE trial : a randomised controlled trial. Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored. If a dose is missed, the patient should take only the next scheduled dose without doubling it.
Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.
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Approval: Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is an unacceptable bradycardia. Do not routinely withdraw chronic beta blocker therapy prior to surgery.
Use this drug during pregnancy only if clearly needed. Respiratory: Wheezing bronchospasm , dyspnea. Hypersensitive Reactions: Pruritus. Hypersensitive Reactions: Laryngospasm, respiratory distress. Bronchospasm: Can usually be reversed by bronchodilators. Version Files Feb 11, 6 current download Nov 12, 3 download Dec 12, 2 download Jan 2, 1 download. NDC 1 2 3 4 5 6 7 8 9 10 11 12 Bottle of 30 NDC Bottle of NDC Product Information.
Inactive Ingredients. Product Characteristics. Marketing Information. Registrant - AstraZeneca AB Toprol XL metoprolol succinate 25 MG as metoprolol succinate
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