Quinidine Gluconate: Package Insert and Label Information (Page 3 of 3)

DOSAGE AND 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 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 in the 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 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 life-threatening ventricular arrhythmias

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.

HOW SUPPLIED

Quinidine gluconate extended-release tablets, 324 mg are white to off-white, round, unscored, debossed MP 66.

Bottles of 30

NDC 53489-141-07

Bottles of 60

NDC 53489-141-06

Bottles of 90

NDC 53489-141-90

Bottles of 100

NDC 53489-141-01

Bottles of 250

NDC 53489-141-03

Bottles of 500

NDC 53489-141-05

Bottles of 1000

NDC 53489-141-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

References:

1.
Aster RH, Curtis BR, McFarland JG, Bougie DW. Drug-induced immune thrombocytopenia: pathogenesis, diagnosis, and management. J Thromb Haemost 2009; 7: 911–8.
2.
Kaufman DW, Kelly JP, Johannes CB, Sandler A, Harmon D, Stolley PD, Shapiro S. Acute thrombocytopenic purpura in relation to the use of drugs. Blood 1993; 82: 2714–18.

Distributed by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 02, November 2014

PRINCIPAL DISPLAY PANEL — 324 mg Tablet Bottle Label

Quinidine 324mg Label
(click image for full-size original)
QUINIDINE GLUCONATE
quinidine gluconate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Quinidine Gluconate (Quinidine) Quinidine Gluconate 324 mg
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code MP;66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-141-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:53489-141-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:53489-141-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
4 NDC:53489-141-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
5 NDC:53489-141-03 250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
6 NDC:53489-141-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
7 NDC:53489-141-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089338 02/10/1987
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Frontida BioPharm Inc. 080243260 ANALYSIS (53489-141), MANUFACTURE (53489-141), PACK (53489-141)

Revised: 02/2018 Sun Pharmaceutical Industries, Inc.

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