openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings
WARNINGS Mortality In many trials of antiarrhythmic therapy for non-life-threatening arrhythmias, active antiarrhythmic therapy has resulted in increased mortality; the risk of active therapy is probably greatest in patients with structural heart disease. In the case of quinidine used to prevent or defer recurrence of atrial flutter/fibrillation, the best available data come from a meta-analysis described under CLINICAL PHARMACOLOGY/Clinical Effects above. In the patients studied in the trials there analyzed, the mortality associated with the use of quinidine was more than three times as great as the mortality associated with the use of placebo. Another meta-analysis, also described under CLINICAL PHARMACOLOGY/Clinical Effects , showed that in patients with various non-life-threatening ventricular arrhythmias, the mortality associated with the use of quinidine was consistently greater than that associated with the use of any of a variety of alternative antiarrhythmics. Proarrhythmic effects Like many other drugs (including all other class IA antiarrhythmics), quinidine prolongs the QT interval, and this can lead to a life-threatening ventricular arrhythmia (see ). The risk of is increased by bradycardia, hypokalemia, hypomagnesemia, hypocalcemia, or high serum levels of quinidine, but it may appear in the absence of any of these risk factors. The best predictor of this arrhythmia appears to be the length of the QT interval, and quinidine should be used with extreme care in patients who have preexisting long-QT syndromes, who have histories of of any cause, or who have previously responded to quinidine (or other drugs that prolong ventricular repolarization) with marked lengthening of the QT interval. Estimation of the incidence of in patients with therapeutic levels of quinidine is not possible from the available data. C torsades de pointes, OVERDOSAGE torsades C torsades de pointes C torsades Other ventricular arrhythmias that have been reported with quinidine include frequent extrasystoles, ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Paradoxical increase in ventricular rate in atrial flutter/fibrillation When quinidine is administered to patients with atrial flutter/fibrillation, the desired pharmacologic reversion to sinus rhythm may (rarely) be preceded by a slowing of the atrial rate with a consequent increase in the rate of beats conducted to the ventricles. The resulting ventricular rate may be very high (greater than 200 beats per minute) and poorly tolerated. This hazard may be decreased if partial atrioventricular block is achieved prior to initiation of quinidine therapy, using conduction-reducing drugs such as digitalis, verapamil, diltiazem, or a ß-receptor blocking agent. Exacerbated bradycardia in sick sinus syndrome In patients with the sick sinus syndrome, quinidine has been associated with marked sinus node depression and bradycardia. Pharmacokinetic considerations Renal or hepatic dysfunction causes the elimination of quinidine to be slowed, while congestive heart failure causes a reduction in quinidine’s apparent volume of distribution. Any of these conditions can lead to quinidine toxicity if dosage is not appropriately reduced. In addition, interactions with coadministered drugs can alter the serum concentration and activity of quinidine, leading either to toxicity or to lack of efficacy if the dose of quinidine is not appropriately modified. (See ) PRECAUTIONS/Drug Interactions . Vagolysis Because quinidine opposes the atrial and A-V nodal effects of vagal stimulation, physical or pharmacological vagal maneuvers undertaken to terminate paroxysmal supraventricular tachycardia may be ineffective in patients receiving quinidine.
warnings table
<table frame="vsides"> <col/> <col/> <thead> <tr> <td valign="top" colspan="2" styleCode=" Lrule Rrule "> </td> </tr> </thead> <tbody> <tr> <td valign="top" styleCode=" Lrule "> <content styleCode="bold">In many trials of antiarrhythmic therapy for non-life-threatening arrhythmias, active antiarrhythmic therapy has resulted in increased mortality; the risk of active therapy is probably greatest in patients with structural heart disease.</content> </td> <td valign="top" styleCode=" Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Lrule "> <content styleCode="bold">In the case of quinidine used to prevent or defer recurrence of atrial flutter/fibrillation, the best available data come from a meta-analysis described under</content> <content styleCode="bold"> <linkHtml href="#LINK_7db890aa-0a2b-46ec-8c0c-3d7e0dd2ab7f">CLINICAL PHARMACOLOGY/Clinical Effects</linkHtml> </content> <content styleCode="bold">above. In the patients studied in the trials there analyzed, the mortality associated with the use of quinidine was more than three times as great as the mortality associated with the use of placebo.</content> </td> <td valign="top" styleCode=" Rrule "> </td> </tr> <tr> <td valign="top" styleCode=" Lrule "> <content styleCode="bold">Another meta-analysis, also described under</content> <content styleCode="bold"> <linkHtml href="#LINK_7db890aa-0a2b-46ec-8c0c-3d7e0dd2ab7f">CLINICAL PHARMACOLOGY/Clinical Effects</linkHtml> </content> <content styleCode="bold">, showed that in patients with various non-life-threatening ventricular arrhythmias, the mortality associated with the use of quinidine was consistently greater than that associated with the use of any of a variety of alternative antiarrhythmics.</content> </td> <td valign="top" styleCode=" Rrule "> </td> </tr> </tbody> </table>
ADVERSE REACTIONS Quinidine preparations have been used for many years, but there are only sparse data from which to estimate the incidence of various adverse reactions. The adverse reactions most frequently reported have consistently been gastrointestinal, including diarrhea, nausea, vomiting, and heartburn/esophagitis. In one study of 245 adult outpatients who received quinidine to suppress premature ventricular contractions, the incidences of reported adverse experiences were as shown in the table below. The most serious quinidine-associated adverse reactions are described above under . WARNINGS Adverse Experiences in a 245-Patient PVC Trial Incidence (%) diarrhea 85 (35) “upper gastrointestinal distress” 55 (22) lightheadedness 37 (15) headache 18 (7) fatigue 17 (7) palpitations 16 (7) angina-like pain 14 (6) weakness 13 (5) rash 11 (5) visual problems 8 (3) change in sleep habits 7 (3) tremor 6 (2) nervousness 5 (2) discoordination 3 (1) Vomiting and diarrhea can occur as isolated reactions to therapeutic levels of quinidine, but they may also be the first signs of , a syndrome that may also include tinnitus, reversible high-frequency hearing loss, deafness, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium. Cinchonism is most often a sign of chronic quinidine toxicity, but it may appear in sensitive patients after a single moderate dose. cinchonism A few cases of , including granulomatous hepatitis, have been reported in patients receiving quinidine. All of these have appeared during the first few weeks of therapy, and most (not all) have remitted once quinidine was withdrawn. hepatotoxicity associated with quinidine therapy have included fever, urticaria, flushing, exfoliative rash, bronchospasm, psoriaform rash, pruritus and lymphadenopathy, hemolytic anemia, vasculitis, pneumonitis, thrombocytopenic purpura, uveitis, angioedema, agranulocytosis, the sicca syndrome, arthralgia, myalgia, elevation in serum levels of skeletal-muscle enzymes, and a disorder resembling systemic lupus erythematosus. Autoimmune and inflammatory syndromes Convulsions, apprehension, and ataxia have been reported, but it is not clear that these were not simply the results of hypotension and consequent cerebral hypoperfusion. There are many reports of syncope. Acute psychotic reactions have been reported to follow the first dose of quinidine, but these reactions appear to be extremely rare. Other adverse reactions occasionally reported include depression, mydriasis, disturbed color perception, night blindness, scotomata, optic neuritis, visual field loss, photosensitivity, and abnormalities of pigmentation.