QUINIDINE GLUCONATE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Quinidine Gluconate (UNII: R6875N380F) (Quinidine - UNII:ITX08688JL)

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

Quinidine Gluconate

Composition:

Quinidine Gluconate 324 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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, 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. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate 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 quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative meas

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINIDINE GLUCONATE- QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
QUINIDINE GLUCONATE
EXTENDED-RELEASE TABLETS USP
RX ONLY
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
H N O • C H O , and its molecular weight is 520.58, of which 62.3%
is quinidine base.
Each quinidine gluconate extended-release tablet contains 324 mg of
quinidine gluconate (202 mg of
quinidine base) in a matrix to provide extended-release; the inactive
ingredients include corn starch,
hydroxypropyl methylcellulose, magnesium stearate, microcrystalline
cellulose, povidone, silicon
dioxide, and sodium alginate.
This product complies with USP Drug Release Test 5.
CLINICAL PHARMACOLOGY
_PHARMACOKINETICS AND METABOLISM_
The absolute BIOAVAILABILITY of quinidine from quinidine gluconate is
70 to 80%. Relative to a solution
of quinidine sulfate, the bioavailability of quinidine from quinidine
gluconate is reported to be 1.03.
The less-than-complete bioavailability is thought to be due to
first-pass elimination by the liver. Peak
serum levels generally appear 3 to 5 hours after dosing; when the drug
is taken with food, absorption is
increased in both rate (27%) and extent (17%). The rate and extent of
absorption of quinidine from
quinidine gluconate are not significantly affected by the
coadministration of an aluminum-hydroxide
antacid. The rate of absorption of quinidine following the ingestion
of grapefruit juice may be
decreased.
The VOLUME OF DISTRIBUTION of quinidine is 2 to 3 L/kg in healthy
young adults, but this may be reduced
to as little as 0.5 L/kg in patients with congestive heart failure, or
increased to 3 to 5 L/kg in patients
with cirrhosis of the liver. At concentrations of 2 to 5