ISOSORBIDE MONONITRATE tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

AvPAK

INN (Mezinárodní Name):

ISOSORBIDE MONONITRATE

Složení:

ISOSORBIDE MONONITRATE 30 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are white, capsule-shaped tablets scored on one side and engraved "KU 128" on the unscored side. They are supplied as follows: NDC 50268-451-15 10 Tablets per card, 5 cards per carton. Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are white, capsule-shaped tablets scored on one side and engraved "KU 119" on the unscored side. They are supplied as follows: NDC 50268-452-15 10 Tablets per card, 5 cards per carton. Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, capsule-shaped tablets engraved "KU 129" on one side. They are supplied as follows: NDC 50268-453-15 10 Tablets per card, 5 cards per carton. Dispensed in Unit Dose package. For Institutional Use Only. Store at 20°-30°C (68°-86°F) [See USP]. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 02/19 AV Rev. 04/19 (P) AvPAK

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
AVPAK
----------
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS
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, hydrogenated castor
oil, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose
and talc.
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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The Isosorbide Mononitrate Extended-Release Tablet, USP 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.
6
9
6
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
relaxation
reduces systemic vascular resistance, systolic arterial pressure and
mean arterial
pressure (afterload). Dilatation of the coronary arterie