ISOSORBIDE MONONITRATE- isosorbide mononitrate tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Par Pharmaceutical

INN（国际名称）:

ISOSORBIDE MONONITRATE

组成:

ISOSORBIDE MONONITRATE 30 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

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 10, 100, 500 and 1000 tablets. Isosorbide Mononitrate Extended-Release Tablets 60 mg are off white, capsule-shaped, scored tablets, debossed "3798" on one side and debossed "V" on the reverse side, packaged as follows: Bottles of 10, 100, 500 and 1000 tablets. Isosorbide Mononitrate Extended-Release Tablets 120 mg are off white, oval tablets, debossed "3799" on one side and debossed "V" on the reverse side, packaged as follows: Bottles of 10, 100, 300 and 1000 tablets. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as described in USP.

授权状态:

Abbreviated New Drug Application

产品特点

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
PAR PHARMACEUTICAL
----------
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.
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
6
9
6
(preload). Arteriolar relaxation reduces systemic vascular resistance,
systolic arterial pre