DILATRATE SR- isosorbide dinitrate capsule, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)

Pieejams no:

Endo Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

ISOSORBIDE DINITRATE

Kompozīcija:

ISOSORBIDE DINITRATE 40 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

dilatrate® -SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide dinitrate is contraindicated in patients who are allergic to it. Do not use dilatrate® -SR in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, vardenafil, or avanafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use dilatrate® -SR in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Produktu pārskats:

dilatrate® -SR (isosorbide dinitrate) 40 mg sustained-release capsules are opaque pink and colorless capsules with white beadlets and are imprinted "AP" and "0920". They are supplied as follows: Bottles of 100        NDC 52244-920-10 Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature].

Autorizācija statuss:

New Drug Application

Produkta apraksts

DILATRATE SR- ISOSORBIDE DINITRATE CAPSULE, EXTENDED RELEASE
ENDO PHARMACEUTICALS INC.
----------
DILATRATE®-SR
(ISOSORBIDE DINITRATE)
SUSTAINED RELEASE CAPSULES
40 MG
RX ONLY
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5
dinitrate, an organic nitrate whose
structural formula is:
and whose molecular weight is 236.14. The organic nitrates are
vasodilators, active on both arteries
and veins. Each dilatrate
-SR sustained release capsule contains 40 mg of isosorbide dinitrate,
in a
microdialysis delivery system that causes the active drug to be
released over an extended period. Each
capsule also contains ethylcellulose, lactose, pharmaceutical glaze,
starch, sucrose and talc. The
capsule shells contain D&C Red 33, D&C Yellow 10, gelatin and titanium
dioxide.
CLINICAL PHARMACOLOGY
The principal pharmacological action of isosorbide dinitrate is
relaxation of vascular smooth muscle
and consequent dilatation of peripheral arteries and veins, especially
the latter. Dilatation of the veins
promotes peripheral pooling of blood and decreases venous return to
the heart, thereby reducing left
ventricular end-diastolic pressure and pulmonary capillary wedge
pressure (preload). Arteriolar
relaxation reduces systemic vascular resistance, systolic arterial
pressure, and mean arterial pressure
(afterload). Dilatation of the coronary arteries also occurs. The
relative importance of preload
reduction, afterload reduction, and coronary dilatation remains
undefined.
Dosing regimens for most chronically used drugs are designed to
provide plasma concentrations that
are continuously greater than a minimally effective concentration.
This strategy is inappropriate for
organic nitrates. Several well-controlled clinical trials have used
exercise testing to assess the
antianginal efficacy of continuously-delivered nitrates. In the large
majority of these trials, active agents
were no more effective than placebo after 24 hours (or less) of
continuous therapy. Attempts to
overcome nitrate tolerance by dose escalati