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| | #REDIRECT [[Pindolol#Adverse Reactions]] |
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| ==Adverse Reactions==
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| 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.
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| ====Potential Adverse Effects====
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| 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).
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| <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.
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| <u>'''Cardiovascular'''</u>: Intensification of AV block. (See CONTRAINDICATIONS)
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| <u>'''Allergic'''</u>: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.
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| <u>'''Hematologic'''</u>: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.
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| <u>'''Gastrointestinal'''</u>: Mesenteric arterial thrombosis; ischemic colitis.
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| <u>'''Miscellaneous'''</u>: Reversible alopecia; Peyronie’s disease.
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| 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.
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| ====Clinical Laboratory====
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| Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during Visken® (pindolol) administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest hepatic impairment, such as decreased serum albumin and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. Alkaline phosphatase, lactic acid dehydrogenase (LDH), and uric acid are also elevated on rare occasions. The significance of these findings is unknown.<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>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Beta blockers]]
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| [[Category:Drugs]]
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