Quinidine gluconate (extended-release tablet): Difference between revisions

Quinidine gluconate (extended-release tablet)
	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

VisualWikitext

Revision as of 18:59, 13 July 2014

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

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

See full prescribing information for complete Boxed Warning.

* 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 gluconate (extended-release tablet) 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 diarrhea, nausea, vomiting, heartburn, and esophagitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Dosing Information

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 gluconate every eight hours. If this regimen has not resulted in conversion after 3 or 4 doses, then the dose is cautiously increased. 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 gluconate is discontinued, and other means of conversion (e.g., direct-current cardioversion) are considered.

In another regimen sometimes used, the patient receives one tablet (324 mg; 202 mg of quinidine base) every eight hours for two days; then two tablets every twelve hours for two days; and finally two tablets every eight hours for up to four days. The four-day stretch may come at one of the lower doses if, in the judgment of the physician, the lower dose is the highest one that will be tolerated. The criteria for discontinuation of treatment with quinidine gluconate are the same as in the other regimen.

Reduction of Frequency of Relapse into Atrial Fibrillation/Flutter

Dosing Information

In a patient with a history of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy with quinidine gluconate should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy with quinidine gluconate, 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 gluconate 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.

Therapy with quinidine gluconate should be begun with one tablet (324 mg; 202 mg of quinidine base) every eight or 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 Information

Dosing regimens for the use of quinidine gluconate 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

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 gluconate (extended-release tablet) in adult patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quinidine gluconate (extended-release tablet) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Quinidine gluconate (extended-release tablet) in pediatric patients.

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 gluconate (extended-release tablet) 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 gluconate (extended-release tablet) in pediatric patients.

Contraindications

Condition1

Warnings

See full prescribing information for complete Boxed Warning.

* 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 gluconate (extended-release tablet) 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 gluconate (extended-release tablet) 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 gluconate (extended-release tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Quinidine gluconate (extended-release tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Quinidine gluconate (extended-release tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Quinidine gluconate (extended-release tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Quinidine gluconate (extended-release tablet) in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Quinidine gluconate (extended-release tablet) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Quinidine gluconate (extended-release tablet) in the drug label.

Pharmacology



Quinidine gluconate (extended-release tablet)
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 atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template: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

File:Quinidine gluconate (extended-release tablet)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Quinidine gluconate (extended-release tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Quinidine gluconate (extended-release tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Quinidine gluconate (extended-release tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Quinidine gluconate (extended-release tablet) in the drug label.

Condition1

Description

How Supplied

Quinidine gluconate extended-release tablets, 324 mg are white to off-white, round, unscored, debossed MP 66. They are available as follows:

NDC 51079-027-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F).
Protect from light.

Storage

There is limited information regarding Quinidine gluconate (extended-release tablet) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Quinidine gluconate (extended-release tablet) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Quinidine gluconate (extended-release tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Quinidine gluconate (extended-release tablet) in the drug label.

Precautions with Alcohol

Alcohol-Quinidine gluconate (extended-release tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Quinidine Gluconate®^[1]

Look-Alike Drug Names

N/A^[2]

Drug Shortage Status

Price

References

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

↑ "QUINIDINE GLUCONATE tablet, extended release".
↑ "http://www.ismp.org". External link in |title= (help)

{{#subobject:

 |Page Name=Quinidine gluconate (extended-release tablet)
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage=
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Quinidine gluconate (extended-release tablet)
 |Label Name=Quinidine gluconate (extended-release tablet)11.png

}}

{{#subobject:

 |Label Page=Quinidine gluconate (extended-release tablet)
 |Label Name=Quinidine gluconate (extended-release tablet)11.png

}}

[1] "QUINIDINE GLUCONATE tablet, extended release".

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 508: / Line 508: @@
 |howSupplied=
-*
+* Quinidine gluconate extended-release tablets, 324 mg are white to off-white, round, unscored, debossed MP 66. They are available as follows:
+: NDC 51079-027-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).
+* Store at 20° to 25°C (68° to 77°F).
+* Protect from light.
 <!--Patient Counseling Information-->