ISOSORBIDE MONONITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide mononitrate tablets are indicated for the prevention and treatment 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. Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide mononitrate is contraindicated in patients who are allergic to it.

Product summary:

Isosorbide mononitrate tablets, USP are available as follows: 10 mg — Each blue, round, tablet imprinted with and 631 on one side and scored on the other side, contains 10 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in blisterpacks of 30 (NDC 0615-5549-39). 20 mg — Each blue, round, tablet imprinted with and 620 on one side and scored on the other side, contains 20 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in blisterpacks of 30 (NDC 0615-5550-39). Dispense in tight containers as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep tightly closed. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-8813 Revised — August 2008

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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ISOSORBIDE MONONITRATE TABLETS, USP
40-8813
REVISED — AUGUST 2008
RX ONLY
DESCRIPTION
Isosorbide mononitrate (diluted), USP, an organic nitrate, is a
vasodilator with effects on both arteries
and veins. The molecular formula is C H NO and the molecular weight is
191.14. The chemical name
for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate
and the compound has the
following structural formula:
Isosorbide mononitrate tablets, USP, for oral administration, contain
10 mg or 20 mg of isosorbide
mononitrate (diluted), USP. In addition, each tablet contains the
following inactive ingredients: calcium
stearate, colloidal silicon dioxide, corn starch, FD&C Blue #1HT
Aluminum Lake, lactose
monohydrate, microcrystalline cellulose, and talc.
CLINICAL PHARMACOLOGY
Isosorbide mononitrate is the major active metabolite of isosorbide
dinitrate (ISDN), and most of the
clinical activity of the dinitrate is attributable to the mononitrate.
The principal pharmacological action of isosorbide mononitrate is
relaxation of vascular smooth
muscle and consequent 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 wedge
pressure (preload). Arteriolar
relaxation reduces systemic vascular resistance, systolic arterial
pressure, and mean arterial pressure
(afterload). Dilatation of the coronary arteries also occurs. The
relative importance of preload
reduction, afterload reduction and coronary dilatation remains
undefined.
PHARMACODYNAMICS: Dosing regimens for most chronically used drugs are
designed to provide plasma
concentrations that are continuously greater than a minimally
effective concentration. This strategy is
inappropriate for organic nitrates. Several well-controlled clinical
trials have used exercise testing