Pindolol adverse reactions: Difference between revisions
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== | ==Adverse Reactions== | ||
Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions. | |||
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The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes. | |||
====Potential Adverse Effects==== | |||
In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Visken® (pindolol). | |||
<u>'''Central Nervous System'''</u>: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. | |||
<u>'''Cardiovascular'''</u>: Intensification of AV block. (See CONTRAINDICATIONS) | |||
<u>'''Allergic'''</u>: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress. | |||
<u>'''Hematologic'''</u>: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura. | |||
<u>'''Gastrointestinal'''</u>: Mesenteric arterial thrombosis; ischemic colitis. | |||
<u>'''Miscellaneous'''</u>: Reversible alopecia; Peyronie’s disease. | |||
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Visken® (pindolol) during investigational use and extensive foreign experience amounting to over 4 million patient-years.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = VISKEN (PINDOLOL) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07fe9cc3-1ef2-420c-b45d-7f1e894b6ef9 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 04:37, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Adverse Reactions
Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions.
 |
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.
Potential Adverse Effects
In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Visken® (pindolol).
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, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS)
Allergic: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.
Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.
Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.
Miscellaneous: Reversible alopecia; Peyronie’s disease.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Visken® (pindolol) during investigational use and extensive foreign experience amounting to over 4 million patient-years.[1]
References
Adapted from the FDA Package Insert.