disopyramide phosphate er- Disopyramide Phosphate capsule, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Disopyramide Phosphate (UNII: N6BOM1935W) (Disopyramide - UNII:GFO928U8MQ)

Boleh didapati daripada:

ETHEX

INN (Nama Antarabangsa):

Disopyramide Phosphate

Borang farmaseutikal:

CAPSULE, EXTENDED RELEASE

Komposisi:

150 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Disopyramide Phosphate Extended-release Capsules, USP are indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The extended-release capsules should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Disopyramide phosphate is contraindicated in the presence of cardiogenic shock, pre-existing second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hyperse

Ringkasan produk:

Disopyramide Phosphate Extended-release Capsules, USP 150 mg are purple and orange hard gelatin capsules imprinted “ETHEX” and “002” in black ink containing 150 mg of disopyramide (as the phosphate) in extended-release beads. NDC Number   Size 58177-002-04   Bottle of 100 Recommended Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F). [see USP Controlled Room Temperature.] Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO  63043-2413

Ciri produk

DISOPYRAMIDE PHOSPHATE ER- DISOPYRAMIDE PHOSPHATE CAPSULE, EXTENDED
RELEASE
ETHEX
----------
Rx Only
DESCRIPTION
Disopyramide phosphate is an antiarrhythmic drug available for oral
administration in extended-release
capsules equivalent to 150 mg of disopyramide present as the
phosphate. The base content of the
phosphate salt is 77.66%. The structural formula of disopyramide
phosphate is:
C H N O.H PO M.W.4 37.4 8
(±)-α-[2-(Diisopropylamino)ethyl]-α-phenyl-2-pyridineacetamide
phosphate (1:1)
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.
Disopyramide Phosphate Extended-release Capsules, USP are designed to
afford a gradual and
consistent release of disopyramide. Thus, for maintenance therapy,
Disopyramide Phosphate Extended-
release Capsules, USP provide the benefit of less frequent dosing
(every 12 hours) as compared with
the every-6-hour dosage schedule of immediate-release capsules.
Inactive ingredients: aluminum hydrate, black iron oxide, calcium
stearate, D&C Red No. 28, D&C
Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C
Red No. 40, gelatin,
lecithin, pharmaceutical glaze, povidone, simethicone, starch,
sucrose, talc and titanium dioxide.
This product meets USP Drug Release Test 2.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTIONS
Disopyramide phosphate is a Type 1 antiarrhythmic drug (i.e., similar
to procainamide and quinidine). _In_
_animal studies_, disopyramide 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