ISOSORBIDE MONONITRATE- isosorbide mononitrate tablet, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)

Dostupno od:

NuCare Pharmaceuticals, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Proizvod sažetak:

Isosorbide Mononitrate Extended-Release Tablets 30 mg are off white, oval, scored tablets, debossed "3797" on one side and debossed "V" on the reverse side, packaged as follows: Bottles of 30 NDC 68071-1953-3 Bottles of 60 NDC 68071-1953-6 Bottles of 90 NDC 68071-1953-9 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as described in USP.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
ISOSORBIDE MONONITRATE
EXTENDED-RELEASE TABLETS USP
30 MG, 60 MG, AND 120 MG
RX ONLY
DESCRIPTION
Isosorbide mononitrate (ISMN), an organic nitrate and the major
biologically active metabolite of
isosorbide dinitrate (ISDN), is a vasodilator with effects on both
arteries and veins.
Isosorbide Mononitrate Extended-Release Tablets, for oral
administration, contain either 30 mg, 60 mg
or 120 mg of isosorbide mononitrate in an extended-release
formulation. In addition, each tablet contains
the following inactive ingredients: colloidal silicon dioxide,
hydrogenated castor oil, hypromellose,
lactose monohydrate, magnesium stearate and microcrystalline
cellulose.
The molecular formula of ISMN is C
H
NO
and the molecular weight is 191.14. The chemical name
for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has
the following structural formula:
ISMN is a white, crystalline, odorless compound which is stable in air
and in solution, has a melting
point of about 90°C, and an optical rotation of +144° (2% in water,
20°C).
Isosorbide mononitrate is freely soluble in water, ethanol, methanol,
chloroform, ethyl acetate, and
dichloromethane.
USP dissolution test pending.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The isosorbide mononitrate product is an oral extended-release
formulation of ISMN, the major active
metabolite of isosorbide dinitrate; most of the clinical activity of
the dinitrate is attributable to the
mononitrate.
The principal pharmacological action of ISMN and all organic nitrates
in general is relaxation of
vascular smooth muscle, producing dilatation of peripheral arteries
and veins, especially the latter.
6
9
6
Dilatation of the veins promotes peripheral pooling of blood,
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 ar