ismo- isosorbide mononitrate tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

isosorbide mononitrate (UNII: LX1OH63030) (isosorbide mononitrate - UNII:LX1OH63030)

Tillgänglig från:

Reddy Pharmaceuticals, LLC

INN (International namn):

isosorbide mononitrate

Läkemedelsform:

TABLET, FILM COATED

Sammansättning:

20 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Ismo 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. Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide mononitrate is contraindicated in patients who are allergic to it. The recommended regimen of Ismo tablets is 20 mg (one tablet) twice daily, with the two doses given 7 hours apart. For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. Dosage adjustments are not necessary for elderly patients or patients with altered renal or hepatic function. As noted above (CLINICAL PHARMACOLOGY ), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The dosing regimen for Ismo tablets provides a daily nitr

Produktsammanfattning:

Ismo® (isosorbide mononitrate) tablets, 20 mg, are available in bottles of 100 (NDC 67857-702-01). Each orange, round, film-coated tablet is engraved “ISMO 20” on one side and scored on the reverse side. Store at 20 - 25° C (68 -77° F) [See USP Controlled Room Temperature]. Dispense in tight container.

Produktens egenskaper

ISMO- ISOSORBIDE MONONITRATE TABLET, FILM COATED
REDDY PHARMACEUTICALS, LLC
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DESCRIPTION
Isosorbide mononitrate is 1,4:3,6-dianhydro-D-glucitol, 5-nitrate, an
organic nitrate whose structural
formula is:
and whose molecular weight is 191.14. The organic nitrates are
vasodilators, active on both arteries
and veins. Each Ismo
tablet contains 20 mg of isosorbide mononitrate. The inactive
ingredients in each
tablet are colloidal silicon dioxide, D&C Yellow 10 Aluminum Lake,
FD&C Yellow 6 Aluminum Lake,
hydroxypropyl methylcellulose, lactose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 20, povidone, sodium starch glycolate, titanium
dioxide and hydroxypropyl
cellulose.
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, due to
its nitric oxide metabolite, is
direct relaxation of vascular smooth muscle. The result is 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 continu-ously 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 tr