ISOSORBIDE MONONITRATE tablet extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 60 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
UNIT DOSE SERVICES
----------
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP 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 Isosorbide mononitrate extended-release tablet, USP, for oral
administration contains either 30 mg
or 60 mg of ISMN.
ISMN 30 mg tablets, USP containes the following inactive ingredients:
colloidal silicon dioxide,
compressible sugar, hydroxypropyl methylcellulose, lactose
monohydrate, magnesium stearate.
ISMN 60 mg tablets, USP contains the following inactive ingredients:
colloidal silicon dioxide,
compressible sugar, hydroxypropyl methylcellulose, yellow iron oxide,
lactose monohydrate,
magnesium stearate.
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). ISMN is freely soluble in
water, ethanol, methanol, chloroform, ethyl acetate and
dichloromethane.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
This 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.
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 vascul