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:

NuCarePharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Isosorbide mononitrate extended-release tablets, USP 30 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and debossed ‘3-0’ across breakline and ‘1104’ on other side. They are supplied as follows: Bottles of 30 NDC 68071-3015-3 Bottles of 60 NDC 68071-3015-6 Bottles of 90 NDC 68071-3015-9 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] strong>Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8053558 Revised February 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
NUCAREPHARMACEUTICALS, INC.
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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 pres