Quinidine Gluconate 324 mg/1
Quinidine Gluconate · TABLET, EXTENDED RELEASE · Sun Pharmaceutical Industries, Inc.
Quinidine Gluconate is a tablet, extended release containing quinidine gluconate at 324 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Quinidine Gluconate
- Generic Name
- Quinidine Gluconate
- NDC Code (Product)
53489-141- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 324 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA089338
- Marketing Start
- 02/10/1987
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION ), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate. In patients with histories of frequent symptomatic episode…
Dosage & Administration
DOSAGE & ADMINISTRATION The dose of quinidine delivered by quinidine gluconate extended-release tablets may be titrated by breaking a tablet in half. If tablets are crushed or chewed, their extended-release properties will be lost. The dosage of quinidine varies considerably depending upon the general condition and the cardiovascular state of the patient. Conversion of atrial fibrillation/flutter to sinus rhythm Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine gluconate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Patients with symptomatic atrial fibrillation/flutter should be treated with quinidine gluconate only after ventricular rate control (e.g., with digitalis or β-blockers) has failed to provide satisfactory control of symptoms. Adequate trials have not identified an optimal regimen of quinidine gluconate for conversion of atrial fibrillation/flutter to sinus rhythm. In one reported regimen, the patient first receives two tablets (648 mg; 403 mg of quinidine base) of quinidine glucona…
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 c interval, and this can lead to torsades de pointes , a life-threatening ventricular arrhythmi…
Contraindications
CONTRAINDICATIONS Quinidine is contraindicated in patients who are known to be allergic to it, or who have a history of immune thrombocytopenia or have developed thrombocytopenic purpura during prior therapy with quinidine or quinine (see WARNINGS ). In the absence of a functioning artificial pacemaker, quinidine is also contraindicated in any patient whose cardiac rhythm is dependent upon a junctional or idioventricular pacemaker, including patients in complete atrioventricular block. Quinidine is also contraindicated in patients who, like those with myasthenia gravis, might be adversely affected by an anticholinergic agent.
Adverse Reactions
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 the reported study that was closest in character to the predominant approved use of quinidine gluconate, 86 adult outpatients with atrial fibrillation were followed for six months while they received slow-release quinidine bisulfate tablets, 600 mg (approximately 400 mg of quinidine base) twice daily. The incidences of adverse experiences reported more than once were as shown in the table below. The most serious quinidine-associated adverse reactions are described above under WARNINGS . ADVERSE EXPERIENCES REPORTED MORE THAN ONCE IN 86 PATIENTS WITH ATRIAL FIBRILLATION Incidence (%) diarrhea 21 (24%) fever 5 (6%) rash 5 (6%) arrythmia 3 (3%) abnormal electrocardiogram 3 (3%) nausea/vomiting 3 (3%) dizziness 3 (3%) headache 3 (3%) asthenia 2 (2%) cerebral ischemia 2 (2%) Vomiting and diarrhea can occur as isolated reactions to therapeutic levels of quinidine, but…
Frequently Asked Questions
What is Quinidine Gluconate used for?
Quinidine Gluconate contains Quinidine Gluconate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Quinidine Gluconate a controlled substance?
Quinidine Gluconate is not classified as a controlled substance by the DEA.
What is the generic name for Quinidine Gluconate?
The generic name for Quinidine Gluconate is Quinidine Gluconate. There are no other listed brand versions of Quinidine Gluconate.
What is the NDC code for Quinidine Gluconate 324 mg/1?
The NDC (National Drug Code) for Quinidine Gluconate 324 mg/1 is 53489-141, listed by Sun Pharmaceutical Industries, Inc..
Other Quinidine Gluconate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)