NORPACE- disopyramide phosphate capsule, gelatin coated NORPACE CR- disopyramide phosphate capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Pfizer Laboratories Div Pfizer Inc

INN (Међународно име):

DISOPYRAMIDE PHOSPHATE

Састав:

DISOPYRAMIDE 100 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Norpace and Norpace CR are 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 Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR 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. Norpace and Norpace CR are 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.

Резиме производа:

Norpace (disopyramide phosphate) is supplied in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate. Norpace 100-mg capsules are white and orange, with markings SEARLE, 2752, NORPACE, and 100 MG. 0025-2752-31 bottle of 100 Norpace 150-mg capsules are brown and orange, with markings SEARLE, 2762, NORPACE, and 150 MG. 0025-2762-31 bottle of 100 Norpace CR (disopyramide phosphate) Controlled-Release is supplied as specially prepared controlled-release beads in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate. Norpace CR 100-mg capsules are white and light green, with markings SEARLE, 2732, NORPACE CR, and 100 mg. 0025-2732-31 bottle of 100 Norpace CR 150-mg capsules are brown and light green, with markings SEARLE, 2742, NORPACE CR, and 150 mg. 0025-2742-31 bottle of 100 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

Статус ауторизације:

New Drug Application

Карактеристике производа

NORPACE- DISOPYRAMIDE PHOSPHATE CAPSULE, GELATIN COATED
NORPACE CR- DISOPYRAMIDE PHOSPHATE CAPSULE, EXTENDED RELEASE
PFIZER LABORATORIES DIV PFIZER INC
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NORPACE
DISOPYRAMIDE PHOSPHATE CAPSULES
NORPACE CR
DISOPYRAMIDE PHOSPHATE EXTENDED-RELEASE CAPSULES
DESCRIPTION
Norpace (disopyramide phosphate) is an antiarrhythmic drug available
for oral
administration in immediate-release and controlled-release 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 Norpace is:
α-[2-(diisopropylamino) ethyl]-α-phenyl- 2-pyridineacetamide
phosphate
Norpace 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.
Norpace is a racemic mixture of _d-_ and _l-_ isomers. This drug is
not chemically related to
other antiarrhythmic drugs.
Norpace CR (controlled-release) capsules are designed to afford a
gradual and
consistent release of disopyramide. Thus, for maintenance therapy,
Norpace CR
provides the benefit of less-frequent dosing (every 12 hours) as
compared with the
every-6-hour dosage schedule of immediate-release Norpace capsules.
®
®
Inactive ingredients of Norpace include corn starch, edible ink, FD&C
Red No. 3, FD&C
Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg
capsule also
contains FD&C Blue No. 1.
Inactive ingredients of Norpace CR include corn starch, D&C Yellow No.
10, edible ink,
ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and
titanium dioxide; the
150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Norpace (disopyramide phosphate) is a Type 1 antiarrhythmic drug
(i.e., similar to
procainamide and quinidine). _In animal studies_ Norpace decreases the
rate of diastolic
depolarization (phase 4) in cells with augmented automaticity,
decreases the upstroke
velocity (phase 0) and increases the