QUINIDINE SULFATE- quinidine sulfate tablet tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINIDINE SULFATE (UNII: J13S2394HE) (QUINIDINE - UNII:ITX08688JL)

Available from:

EPIC PHARMA, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine sulfate should be discontinued. Chronic therapy with quinidine sulfate 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 judgement of the physician and the patient, the risks of prophylactic therapy with quinidine sulfate. The increased risk of death should specifically be considered. Quinidine sulfate 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. Quinidine sulfate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are lifethreatening. 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 quinidine sulfate) have not been shown to enhance survival in patients with ventricular arrhythmias. Quinidine sulfate is also indicated in the treatment of life-threatening Plasmodium falciparum malaria . Quinidine is contraindicated in patients who are known to be allergic to it, or who have developed thrombocytopenic purpura during prior therapy with quinidine or quinine. In the absence of a functioning artificial pacemaker, quinidine is also contraindicated in any patient whose cardiac rhythm is dependent upon a junctional or idioventricular pacemaker, including patients in complete atrioventricular block. Quinidine is also contraindicated in patients who, like those with myasthenia gravis, might be adversely affected by an anticholinergic agent.

Product summary:

Quinidine Sulfate Tablets are supplied as follows: 200 mg - White tablet scored imprinted E511 NDC 42806-513-30 bottles of 30 NDC 42806-513-01 bottles of 100 300 mg - White tablet scored imprinted E512 NDC 42806-512-30 bottles of 30 NDC 42806-512-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev.06-2023-00 MF512REV06/23 OS0005

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINIDINE SULFATE- QUINIDINE SULFATE TABLET TABLET
EPIC PHARMA, LLC
----------
QUINIDINE SULFATE TABLETS, USP
DESCRIPTION
Quinidine is an antimalarial schizonticide and an antiarrhythmic agent
with class 1A
activity; it is the d-isomer of quinine, and its molecular weight is
324.43. Quinidine sulfate
is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol,
6’- methoxy-, (9S)-,
sulfate (2:1) dihydrate; its structural formula is:
Its molecular formula is: C
H
N O ∙H SO ∙2H O; and its molecular weight is 782.96,
of which 82.9% is quinidine base.
Quinidine sulfate occurs as fine needle-like, white crystals,
frequently cohering in
masses, or fine, white powder. It is odorless, has a very bitter
taste, and darkens on
exposure to light. It is slightly soluble in water, soluble in alcohol
and in chloroform, and
insoluble in ether.
Each tablet, for oral administration, contains 200 mg of quinidine
sulfate (equivalent to
166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to
249 mg of quinidine
base). In addition, each tablet contains the following inactive
ingredients: confectioner’s
sugar, corn starch, microcrystalline cellulose, pregelatinized starch
and zinc stearate.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The absolute bioavailability of quinidine from quinidine sulfate
tablets is about 70%, but
this varies widely (45 to 100%) between patients. The
less-than-complete bioavailability is
the result of first-pass metabolism in the liver. Peak serum levels
generally appear about
2 hours after dosing; the rate of absorption is somewhat slowed when
the drug is taken
with food, but the extent of absorption is not changed.
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
40
48
4
4
2
4
2
increased to 3 to 5 L/kg in patients with cirrhosis of the liver. At
concentrations of 2 to 5
mg/L (6.5 to 16.2 μmol/L), the fraction of quinidine bound to plasma
prote