ISOSORBIDE MONONITRATE tablet extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nama Internasional):

ISOSORBIDE MONONITRATE

Komposisi:

ISOSORBIDE MONONITRATE 60 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
ISOSORBIDE MONONITRATE
EXTENDED-RELEASE TABLETS
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.
Each tablet, for oral administration, contains 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, microcrystalline cellulose and talc.
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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The Isosorbide Mononitrate Extended-Release Tablet, USP 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.
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 arterial pressure and
mean arterial pressure (afterload)