A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Quinaglute Indications, Dosage, Storage, Stability - Quinidine Gluconate
Quinaglute Indications, Dosage, Storage, Stability - Quinidine Gluconate
INDICATIONS
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, QUINAGLUTE® is indicated as a means of restoring normal
sinus rhythm. If this
use of QUINAGLUTE® does not restore sinus
rhythm within a reasonable
time (see DOSAGE AND ADMINISTRATION
), then
QUINAGLUTE® should be discontinued.
Reduction of frequency
of relapse into atrial
fibrillation/flutter: Chronic therapy
with QUINAGLUTE® 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 QUINAGLUTE®
. The increased risk of
death should specifically
be considered. QUINAGLUTE® 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
episodes of atrial fibrillation/flutter,
the goal of therapy
should be an increase in the average
time between episodes.
In most patients, the tachyarrhythmia
will recur during therapy, and a single recurrence
should not be interpreted as therapeutic
failure.
Suppression of ventricular
arrhythmias: QUINAGLUTE® is also indicated for the suppression
of recurrent documented ventricular arrhythmias, such
as sustained ventricular
tachycardia, that
in the judgment of the physician
are life-threatening. Because of the proarrhythmic effects of quinidine,
its use with ventricular
arrhythmias of lesser severity is generally not recommended, and
treatment of patients
with asymptomatic ventricular premature
contractions should be avoided. Where possible, therapy should be
guided by the results of programmed electrical stimulation
and/or Holter monitoring with exercise.
Antiarrhythmic drugs (including QUINAGLUTE® ) have not been
shown to enhance survival
in patients with ventricular
arrhythmias.
DOSAGE AND ADMINISTRATION
The dose of quinidine
delivered by QUINAGLUTE DURA-TABS® 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 QUINAGLUTE® 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 QUINAGLUTE® only after ventricular
rate control
(e.g., with digitalis or B-blockers) has failed to provide satisfactory
control of symptoms.
Adequate trials have not identified an optimal regimen
of QUINAGLUTE® 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 QUINAGLUTE® 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 QUINAGLUTE® 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 QUINAGLUTE® 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 QUINAGLUTE®
should be an increase in the average
time between episodes.
In most patients, the tachyarrhythmia
will recur during therapy
with QUINAGLUTE®, 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 QUINAGLUTE® 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 QUINAGLUTE® 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
QUINAGLUTE DURA-TABS® tablets are 324 mg
white to off-white, round
tablets embossed with C in a flask
design on one side and
with a clock-like design on the other.
The tablets are available in bottles and unit-dose packages as follows:
| bottle of 100 |
NDC 50419-101-10
|
| bottle of 250 |
NDC 50419-101-25
|
| bottle of 500 |
NDC 50419-101-50
|
| unit-dose box of 100 |
NDC 50419-101-11
|
Store tablets at controlled room
temperature (15-30°
C; 59-86° F).
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