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| __NOTOC__
| | #REDIRECT [[Procainamide#Adverse Reactions]] |
| {{Propafenone}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| ===6.1 Clinical Trials Experience===
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| Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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| Adverse reactions associated with RYTHMOL occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of subjects treated with RYTHMOL have discontinued treatment because of adverse reactions.
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| Adverse reactions reported for > 1.5% of 474 subjects with SVT who received RYTHMOL in US clinical trials are presented in Table 1 by incidence and percent discontinuation, reported to the nearest percent.
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| {|
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| |[[File:rythmol01.jpg|thumb|600px]]
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| In controlled trials in subjects with ventricular arrhythmia, the most common reactions reported for RYTHMOL and more frequent than on placebo were unusual taste, [[dizziness]] first degree AV block, intraventricular conduction delay, [[nausea]] nd/or [[vomiting]] and [[constipation]] Headache was relatively common also, but was not increased compared with placebo. Other reactions reported more frequently than on placebo or comparator and not already reported elsewhere included [[anxiety]], [[angina]], second-degree AV block, bundle branch block, loss of balance, congestive [[heart failure]], and [[dyspepsia]].
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| Adverse reactions reported for ≥1% of 2,127 subjects with ventricular [[arrhythmia ]]who received propafenone in US clinical trials were evaluated by daily dose. The most common adverse reactions appeared dose-related (but note that most subjects spent more time at the larger doses), especially [[dizziness]] [[nausea]] and/or [[vomiting]], unusual taste, [[constipation]], and [[blurred vision]]. Some less common reactions may also have been dose-related such as first-degree AV block, congestive heart failure, dyspepsia, and weakness. Other adverse reactions included [[rash]] [[syncope]] chest pain, abdominal pain, [[ataxia]], and [[hypotension]]. | |
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| In addition, the following adverse reactions were reported less frequently than 1% either in clinical trials or in marketing experience. Causality and relationship to propafenone therapy cannot necessarily be judged from these events.
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| <u>Cardiovascular System</u>: Atrial flutter, AV dissociation, [[cardiac arrest]], [[flushing]], hot flashes sick sinus syndrome, sinus pause or arrest, [[supraventricular tachycardia]].
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| <u>Nervous System</u>: Abnormal dreams, abnormal speech, abnormal vision, [[confusion]], [[depression]] memory loss, [[numbness]] paresthesias, [[psychosis]]/[[mania]], [[seizures]] (0.3%), [[tinnitus]], unusual smell sensation, [[vertigo]].
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| <u>Gastrointestinal</u>: [[Cholestasis]] , elevated liver enzymes (alkaline phosphatase, serum transaminases), [[gastroenteritis]], [[hepatitis]] .
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| <u>Hematologic</u>: [[Agranulocytosis]], [[anemia]], [[bruising]], [[granulocytopenia]], [[leukopenia]], [[purpura]], [[thrombocytopenia]].
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| <u>Other</u>: [[Alopecia]], eye irritation, [[impotence]], increased glucose, positive ANA (0.7%), muscle cramps, muscle weakness, nephrotic syndrome, [[pain]], [[pruritus]].
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| ===6.2 Postmarketing Experience===
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| The following adverse reactions have been identified during post-approval use of RYTHMOL. 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.
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| <u>Gastrointestinal</u>: A number of patients with liver abnormalities associated with propafenone therapy have been reported in postmarketing experience. Some appeared due to hepatocellular injury, some were cholestatic, and some showed a mixed picture. Some of these reports were simply discovered through clinical chemistries, others because of clinical symptoms including fulminant [[hepatitis]] and death. One case was rechallenged with a positive outcome.
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| <u>Blood and Lymphatic System</u>: Increased bleeding time.
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| <u>Immune System</u>: [[Lupus erythematosis]].
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| <u>Nervous System</u>: [[Apnea]], [[coma]].
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| <u>Renal and Urinary</u>: [[Hyponatremia]]/inappropriate ADH secretion, [[kidney failure]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=17e47845-daad-434c-a784-6d3875b0d704 | publisher = | date = | accessdate = 11 March 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| [[Category:Benzamides]]
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| [[Category:Anilines]]
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| [[Category:Sodium channel blockers]]
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| [[Category:Antiarrhythmic agents]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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