ISOSORBIDE MONONITRATE- isosorbide mononitrate tablet, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Heritage Pharmaceuticals, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are White, biconvex oval shaped tablets, scored and embossed "30" on one side. Bottles of 30 NDC 23155-519-03 Bottles of 100 NDC 23155-519-01 Bottles of 500 NDC 23155-519-05 Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are Light yellow, biconvex oval shaped tablets, scored on both sides and embossed ‘DX 31’ on one side. Bottles of 90 NDC 23155-178-09 Bottles of 100 NDC 23155-178-01 Bottles of 500 NDC 23155-178-05 Isosorbide mononitrate Extended-Release Tablets, USP 120 mg are white, biconvex, oval-shaped tablets, embossed with '120' on one side. Bottles of 100 NDC 23155-628-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from excessive moisture. Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816, 1.866.901.DRUG (3784) Manufactured by: Dexcel Ltd. 1 Dexcel St. Or-Akiva, 3060000, Israel. Issued: 10/2018

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
HERITAGE PHARMACEUTICALS, INC.
----------
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, ISMN 30 mg tablets,
USP contains 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, lactose
monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg
tablets, USP contains the following
inactive ingredients: colloidal silicon dioxide, hydroxypropyl
cellulose, hypermellose, lactose
monohydrate, magnesium stearate 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. Isosorbide
Mononitrate Extended-Release 120 mg Tablets, USP meets USP Dissolution
Test 7.
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 g