MONOKET- 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:

Lannett Company, Inc.

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

monoket® is 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. Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use monoket® in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil.  Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use monoket® in patients who are taking the soluble guanylate cyclase stimulator riociguat.  Concomitant use can cause hypotension.

Product summary:

monoket® (isosorbide mononitrate tablets, USP), 10 mg are white, round, scored and engraved "10" on one side and engraved "SCHWARZ 610" on the other. They are supplied as follows: monoket® (isosorbide mononitrate tablets, USP), 20 mg are white, round, scored and engraved "20" on one side and engraved "SCHWARZ 620" on the other. They are supplied as follows: Store at controlled room temperature 20°-30°C (68°-86°F) [See USP]. Keep tightly closed.

Authorization status:

New Drug Application

Summary of Product characteristics

MONOKET- ISOSORBIDE MONONITRATE TABLET
LANNETT COMPANY, INC.
----------
MONOKET
(ISOSORBIDE MONONITRATE TABLETS, USP)
RX ONLY
DESCRIPTION
monoket
, an organic nitrate, is a vasodilator with effects on both arteries
and veins. The empirical
formula is C H NO and the molecular weight is 191.14. The chemical
name for monoket
is 1,4:3,6-
Dianhydro-D-glucitol 5-nitrate and the compound has the following
structural formula:
monoket
is available in 10 mg and 20 mg tablets. Each tablet also contains as
inactive ingredients:
lactose, talc, colloidal silicon dioxide, starch, microcrystalline
cellulose and aluminum stearate.
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. Dilation 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 to assess the
antianginal efficacy of continuously-delivered nitrates. In the large
majority of these trials, active agents
were indistinguishable from placebo after 24 hours (or less) of
continuous therapy. Attempts to
overcome tolerance by dose e