|
|
| (4 intermediate revisions by 2 users not shown) |
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Metoprolol succinate#Adverse Reactions]] |
| {{Metoprolol}}
| |
| {{CMG}}
| |
| | |
| The following adverse reactions are described elsewhere in labeling:
| |
| | |
| * Worsening [[angina]] or [[myocardial infarction]]. ''[see [[Toprol XL warnings and precautions|Warnings and Precautions]]]''
| |
| | |
| * Worsening [[heart failure]]. ''[see [[Toprol XL warnings and precautions|Warnings and Precautions]]]''
| |
| | |
| * Worsening [[AV block]]. ''[see [[Toprol XL contraindications|Contraindications]]]''
| |
| | |
| ====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 trial]]s of another drug and may not reflect the rates observed in practice. The adverse reaction information from [[clinical trial]]s does, however, provide a basis for identifying the [[adverse event]]s 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 TOPROL-XL in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to [[placebo]] (n=2001), 10.3% of TOPROL-XL 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 TOPROL-XL group and greater than [[placebo]] by more than 0.5%, regardless of the assessment of causality.
| |
| | |
| {|
| |
| | [[File:Toprol02.png|800px|thumb]]
| |
| |}
| |
| | |
| '''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, TOPROL-XL 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. TOPROL-XL 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]].
| |
| | |
| ====Post-Marketing Experience====
| |
| | |
| The following adverse reactions have been identified during post-approval use of TOPROL-XL or immediate-release metoprolol. 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 phenomenon|Raynaud]] type), [[palpitation]]s, [[peripheral edema]], [[syncope]], [[chest pain]] and [[hypotension]].
| |
| | |
| '''Respiratory''': [[Wheezing]] ([[bronchospasm]]), [[dyspnea]].
| |
| | |
| '''Central Nervous System''': [[Confusion]], short-term [[memory loss]], [[headache]], [[somnolence]], [[nightmare]]s, [[insomnia]], [[anxiety]]/[[nervousness]], [[hallucination]]s, [[paresthesia]].
| |
| | |
| '''Gastrointestinal''': [[Nausea]], [[dry mouth]], [[constipation]], [[flatulence]], [[heartburn]], [[hepatitis]], [[vomiting]].
| |
| | |
| '''Hypersensitive Reactions''': Pruritus.
| |
| | |
| '''Miscellaneous''': Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, sweating, photosensitivity, taste disturbance.
| |
| | |
| '''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 TOPROL-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.
| |
| | |
| '''Hematologic''': Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
| |
| | |
| '''Hypersensitive Reactions''': Laryngospasm, respiratory distress.
| |
| | |
| ====Laboratory Test Findings====
| |
| | |
| Clinical laboratory findings may include elevated levels of serum transaminase, alkaline phosphatase, and lactate dehydrogenase.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=01038198-b4f0-41f3-9a9c-5c84e5a0d3b9 | publisher = | date = | accessdate = }}</ref>
| |
| | |
| ==References==
| |
| | |
| {{Reflist}}
| |
| | |
| {{FDA}}
| |
| | |
| [[Category:Beta blockers]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| [[Category:Drugs]]
| |