Quinidine sulfate

Quinidine sulfate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Black Box Warning

WARNINGS See full prescribing information for complete Boxed Warning. 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. 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 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.

Overview

Quinidine sulfate is an antiarrhythmic that is FDA approved for the {{{indicationType}}} of symptomatic atrial fibrillation/flutter and life-threatening ventricular arrhythmias. There is a Black Box Warning for this drug as shown here. Common adverse reactions include chest pain, palpitations, rash, diarrhea, esophagitis, heartburn, nausea, vomiting, lightheadedness, visual disturbance, and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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 sulfate 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 sulfate 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 sulfate for conversion of atrial fibrillation/flutter to sinus rhythm.

• Dosing Information

• Therapy with quinidine sulfate should begin with one tablet (300 mg; 249 mg of quinidine base) every 8 to 12 hours.
• If this regimen is well tolerated, if the serum quinidine level is still well within the laboratory’s therapeutic range, and if this regimen has not resulted in conversion, then the dose may be cautiously raised. If, at any point during administration, the QRS complex widens to 130% of its pre-treatment duration; the QTc interval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension, then quinidine sulfate is discontinued, and other means of conversion (e.g., direct-current cardioversion) are considered.

Reduction of Frequency of Relapse into Atrial Fibrillation/Flutter

• In a patient with a history of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy with quinidine sulfate should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy with quinidine sulfate, and a single recurrence should not be interpreted as therapeutic failure.

• Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine sulfate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Monitoring should be continued for two or three days after initiation of the regimen on which the patient will be discharged.

• Dosing Information

• Therapy with quinidine sulfate should begin with one tablet (300 mg; 249 mg of quinidine base) every eight to twelve hours.
• If this regimen is well tolerated, if the serum quinidine level is still well within the laboratory’s therapeutic range, and if the average time between arrhythmic episodes has not been satisfactorily increased, then the dose may be cautiously raised. The total daily dosage should be reduced if the QRS complex widens to 130% of its pre-treatment duration; the QTc interval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension.

Suppression of Ventricular Arrhythmias

• Dosing regimens for the use of quinidine sulfate in suppressing life-threatening ventricular arrhythmias have not been adequately studied. Described regimens have generally been similar to the regimen described just above for the prophylaxis of symptomatic atrial fibrillation/flutter. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Quinidine sulfate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quinidine sulfate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness of the antiarrhythmic use of quinidine in pediatric patients have not been established in well-controlled clinical trials.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Quinidine sulfate in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quinidine sulfate in pediatric patients.

Contraindications

• Condition1

Warnings

WARNINGS See full prescribing information for complete Boxed Warning. 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. 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 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.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Quinidine sulfate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Quinidine sulfate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Quinidine sulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Quinidine sulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Quinidine sulfate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Quinidine sulfate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Quinidine sulfate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Quinidine sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Quinidine sulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Quinidine sulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Quinidine sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Quinidine sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Quinidine sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Quinidine sulfate in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Quinidine sulfate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Quinidine sulfate in the drug label.

Pharmacology

Quinidine sulfate
Systematic (IUPAC) name
(S)-(6-Methoxyquinolin-4-yl)((2R,4S,8R)-8-vinylquinuclidin-2-yl)methanol
Identifiers
CAS number	56-54-2
ATC code	C01BA01
PubChem	441074
DrugBank	DB00908
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	324.417 g/mol
SMILES	eMolecules & PubChem
Synonyms	(2-ethenyl- 4-azabicyclo [2.2.2] oct- 5-yl)- (6-methoxyquinolin- 4-yl)- methanol,
Pharmacokinetic data
Bioavailability	70-80%
Metabolism	50-90% Hepatic
Half life	6-8h
Excretion	Renal via urine
Therapeutic considerations
Pregnancy cat.	C(AU) C(US)
Legal status	Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)
Routes	Oral, IM

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Quinidine sulfate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Quinidine sulfate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Quinidine sulfate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Quinidine sulfate in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Quinidine sulfate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Quinidine sulfate in the drug label.

Precautions with Alcohol

• Alcohol-Quinidine sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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