ISOSORBIDE MONONITRATE tablet, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Ingenus Pharmaceuticals, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Isosorbide Mononitrate Extended-Release Tablets USP, 30 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 175' one side and scored on the other side. They are supplied as follows: Bottles of 100             NDC 50742-175-01 Bottles of 500             NDC 50742-175-05 Isosorbide Mononitrate Extended-Release Tablets USP, 60 mg are white to off-white, uncoated, capsule shaped tablets debossed with 'ING 176' one side and scored on the other side. They are supplied as follows: Bottles of 100             NDC 50742-176-01 Bottles of 500             NDC 50742-176-05 Isosorbide Mononitrate Extended-Release Tablets USP, 120 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 177' one side and plain on the other side. They are supplied as follows: Bottles of 100             NDC 50742-177-01 Store at 20o -30o C (68o -86o F) [See USP Controlled Room Temperature]. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in India DRUGS/TS/23/2007 Rev.: 09/2023

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
INGENUS PHARMACEUTICALS, LLC
----------
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP
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 tablets 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: microcrystalline cellulose,
hydroxypropyl cellulose,
hypromellose, colloidal silicon dioxide, lactose monohydrate and
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 +140° to
146° (2% in water,
20°C).
Isosorbide mononitrate is freely soluble in water, acetic acid,
alcohol, acetone and ethyl
acetate; soluble in ether and chloroform, slightly soluble in toluene;
practically insoluble in
aliphatic hydrocarbons.
_Isosorbide mononitrate extended-release tablets, USP meets USP
Dissolution Test 8._
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Isosorbide mononitrate extended-release tablet are 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
6
9
6
relaxation of vascular smooth muscle, producing dilatation of
peripheral arteries and
veins, especially the latter. Dilatation of the veins promotes
peripheral pooling of blood
and decreases venous return to the heart, thereby reducing left
ventricular end-diastolic
pressure and pulmonary capillary