Quinidine Gluonate
Generic Name: quinidine gluonate
Brand Names:
Quinidine Gluconate
DESCRIPTION Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is: Its empirical formula is C 20 H 24 N 2 O 2 • C 6 H 12 O 7 , and its molecular weight is 520.58, of which 62.3% is quinidine base.
Overview
DESCRIPTION Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is: Its empirical formula is C 20 H 24 N 2 O 2 • C 6 H 12 O 7 , and its molecular weight is 520.58, of which 62.3% is quinidine base.
Uses
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.
Dosage
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.
Side Effects
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.
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. 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 ).
Storage
HOW SUPPLIED Quinidine gluconate extended-release tablets, 324 mg are round white tablets, debossed “E27” on one side. Bottles of 100 NDC 71930-016-12 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP.
Frequently Asked Questions
What is Quinidine Gluonate used for?▼
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.
What are the side effects of Quinidine Gluonate?▼
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.
What are the important warnings for Quinidine Gluonate?▼
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. 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 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.