ISOSORBIDE MONONITRATE tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

INN (Nome Internazionale):

ISOSORBIDE MONONITRATE

Composizione:

ISOSORBIDE MONONITRATE 30 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral ISMN 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.

Dettagli prodotto:

Isosorbide mononitrate extended-release tablets, USP (30 mg): White, biconvex oval shaped tablets, scored and embossed "30" on one side. Bottle of 30 NDC 23155-519-03 Bottle of 100 NDC 23155-519-01 Bottle of 500 NDC 23155-519-05 Isosorbide mononitrate extended-release tablets, USP (60 mg): Light yellow, biconvex oval shaped tablets, scored on both sides and embossed ‘DX 31’ on one side. Bottle of 90 NDC 23155-178-09 Bottle of 100 NDC 23155-178-01 Bottle of 500 NDC 23155-178-05   STORAGE Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from excessive moisture. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901. DRUG (3784) Manufactured by: Dexcel Ltd. 1 Dexcel St. Or-Akiva 3060000, Israel Issued: 11/16

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
NUCARE 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 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,
6
9
6
decreases venous return to the heart, thereby reducing left
ventricular end-diastolic
pressure and pulmonary capillary wedge pressure (preload). Arteriolar
relaxation
reduces