ISOSORBIDE MONONITRATE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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,
decreases venous return to the heart,
thereby reducing left ventricular end-diastolic pressure and pulmonary
capillary wedge pressure
(preload). Arteriolar rel