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| __NOTOC__
| | #REDIRECT [[Penbutolol#Adverse Reactions]] |
| {{Penbutolol}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| levatol® is usually well tolerated in properly selected patients. Most adverse effects observed during clinical trials have been mild and reversible.
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| Table 1 lists the adverse reactions reported from 4 controlled studies conducted in the United States involving once-a-day administration of levatol® (at doses ranging from 10 to 120 mg) as monotherapy or in combination with hydrochlorothiazide. levatol® doses above 40 mg/day are not, however, recommended. The table includes only those events where the prevalence rate in the levatol® group was at least 1.5%, or where the reaction is of particular interest.
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| Over a dose range from 10 to 40 mg, once a day, fatigue, nausea, and sexual impotence occurred at a greater frequency as the dose was increased.
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| In a double-blind clinical trial comparing levatol® (40 mg and greater once a day) and propranolol (40 mg or more twice a day), heart rates of less than 60 beats/min. were recorded at least once in 25% of the patients in the group receiving levatol® and in 37% of the patients in the propranolol group. Corresponding figures for heart rates of less than 50 beats/min. were 1.2% and 6% respectively. No symptoms associated with bradycardia were reported.
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| Discontinuations of levatol® because of adverse reactions have ranged between 2.4% and 6.9% of patients in double-blind, parallel, controlled clinical trials, as compared to 1.8% to 4.1% in the corresponding control groups that were given placebo. The frequency and severity of adverse reactions have not increased during long-term administration of levatol®. The prevalence of adverse reactions reported from 4 controlled clinical trials (referred to in Table 1) as reasons for discontinuation of therapy by>0.5% of the levatol® group is listed in Table 2.
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| '''Potential Adverse Effects''': In addition, certain adverse effects not listed above have been reported with other ß-blocking agents and should also be considered as potential adverse effects of levatol®.
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| '''Central Nervous System''': Reversible mental depression progressing to[[ catatonia]] (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).
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| '''Cardiovascular''': Intensification of AV block (see CONTRAINDICATIONS).
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| '''Allergic''': [[Erythematous rash]], fever combined with aching and [[sore throat]], [[laryngospasm]], and respiratory distress.
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| '''Hematologic''': [[Agranulocytosis]], nonthrombocytopenic and thrombocytopenic [[purpura]].
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| '''Gastrointestinal''': [[Mesenteric arterial thrombosis]] and [[ischemic colitis]].
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| '''Miscellaneous''': Reversible alopecia and Peyronie’s disease. The oculomucocutaneous syndrome associated with the ß-blocker practolol has not been reported with levatol® during investigational use and extensive foreign clinical experience.
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| <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LEVATOL (PENBUTOLOL SULFATE) TABLET [ACTIENT PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d241fc80-2c55-4dbb-bdb2-44f731afa137 | publisher = | date = | accessdate = 4 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Beta blockers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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