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:

A-S Medication Solutions

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:

Product: 50090-0786 NDC: 50090-0786-2 90 TABLET, EXTENDED RELEASE in a BOTTLE

授权状态:

Abbreviated New Drug Application

产品特点

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
A-S MEDICATION SOLUTIONS
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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 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, diethyl phthalate, hydrogenated castor oil,
hydroxypropyl cellulose,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, talc and titanium
dioxide.
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.
For 30 mg: Meets USP Dissolution Test 6.
For 60 mg and 120 mg: Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The isosorbide mononitrate extended-release tablet 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
6
9
6
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 pressur