DISOPYRAMIDE PHOSPHATE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DISOPYRAMIDE PHOSPHATE (UNII: N6BOM1935W) (DISOPYRAMIDE - UNII:GFO928U8MQ)

Disponible des:

AvKARE

Designació comuna internacional (DCI):

DISOPYRAMIDE PHOSPHATE

Composición:

DISOPYRAMIDE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Disopyramide Phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Disopyramide Phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Disopyramide Phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Disopyramide Phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hypersensitivity to the drug.

Resumen del producto:

Disopyramide Phosphate is supplied as: 100 mg - hard gelatin capsule with a light-blue body imprinted "93-3127" and a scarlet cap imprinted "93-3127", containing 100 mg of disopyramide base present as the phosphate, in bottles of 100. 42291-234-01. 150 mg - hard gelatin capsule with a scarlet body imprinted "93-3129" and a buff cap imprinted "93-3129", containing 150 mg of disopyramide base present as the phosphate, in bottles of 100.  42291-235-01 Store at 20º to 25º (68º to77ºF) [ See USP Controlled Room Temperature]. Manufactured For: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. I 07/12 AV 01/14 (P)

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DISOPYRAMIDE PHOSPHATE- DISOPYRAMIDE PHOSPHATE CAPSULE
AVKARE
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DISOPYRAMIDE PHOSPHATE CAPSULES, USP
DESCRIPTION
Disopyramide Phosphate is an antiarrhythmic drug available for oral
administration in
capsules containing 100 mg or 150 mg of disopyramide base, present as
the
phosphate. The base content of the phosphate salt is 77.6%. The
structural formula of
Disopyramide Phosphate is:
C
H
N
O·H
PO
M.W. 437.47
α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide
phosphate
Disopyramide Phosphate is freely soluble in water, and the free base
(pKa 10.4) has an
aqueous solubility of 1 mg/mL. The chloroform:water partition
coefficient of the base is
3.1 at pH 7.2.
Disopyramide Phosphate is a racemic mixture of _d_- and _l_-isomers.
This drug is not
chemically related to other antiarrhythmic drugs.
INACTIVE INGREDIENTS: _Capsules:_ Lactose Monohydrate, Magnesium
Stearate and
Sodium Starch Glycolate.
_Capsule Print and Shell Constituents:_ Black Iron Oxide, D&C Red #28,
D&C Red #33,
D&C Yellow
#10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum
Lake,
FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, Gelatin,
Propylene Glycol,
Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate and Titanium
Dioxide.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Disopyramide Phosphate is a Type 1 antiarrhythmic drug (ie, similar to
procainamide and
quinidine). _In animal studies,_ Disopyramide Phosphate decreases the
rate of diastolic
depolarization (phase 4) in cells with augmented automaticity,
decreases the upstroke
velocity (phase 0) and increases the action potential duration of
normal cardiac cells,
decreases the disparity in refractoriness between infarcted and
adjacent normally
perfused myocardium, and has no effect on alpha- or beta-adrenergic
receptors.
21
29
3
3
4
ELECTROPHYSIOLOGY
In man, Disopyramide Phosphate at therapeutic plasma levels shortens
the sinus node
recovery time, lengthens the effective refractory period of the
atrium, and has a minimal
effect on the effective refractory pe