ISOSORBIDE MONONITRATE ER 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:

Direct Rx

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 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 100 Bottles of 500 Bottles of 1000 Bottles of 4000 100 Unit dose tablets Isosorbide mononitrate extended-release tablets, USP 60 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and ‘60-60’ debossing across breakline and ‘1105’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1000 Bottles of 2000 100 Unit dose tablets Isosorbide mononitrate extended-release tablets, USP 120 mg are white to off-white, oval shaped, film coated tablets having debossed ‘120’ on one side and ‘1106’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1000 100 Unit dose tablets 28 Unit dose tablets Store at 20°-25°C (68°-77°F), excursions permitted to 6-5915°-30°C (59°-86°F) [see USP Controlled Room Temperature] [logo] 30mg, 60mg & 120mg 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 January 2018 30mg Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA. For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8057361 Revised January 2018

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ISOSORBIDE MONONITRATE ER- ISOSORBIDE MONONITRATE ER TABLET, EXTENDED
RELEASE
DIRECT RX
----------
ISOSORBIDE MONONITRATE ER
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 C6H9NO6 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:
[Image]
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.
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
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,
sy