ISOSORBIDE MONONITRATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

NCS HealthCare of KY, LLC dba Vangard Labs

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 ISMN is not sufficiently rapid for this product to be useful in aborting an acute angina 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 30 mg tablets are oval, reddish pink, film-coated tablets, debossed "N" bisect "30" on one side and bisect on the other side, packaged as follows: NDC  0615-8043-39 blistercard of 30 tablets NDC 0615-8043-05 blistercard of 15 tablets NDC 0615-8043-30 unit dose box of 30 tablets Isosorbide mononitrate extended-release 60 mg tablets are oval, yellow, film-coated tablets, debossed "N" bisect "60" on one side and bisect on the other side, packaged as follows: NDC  0615-8044-39 blistercard of 30 tablets NDC  0615-8044-05 blistercard of 15 tablets Isosorbide mononitrate extended-release 120 mg tablets are oval, white, film-coated tablets, debossed "N120" on one side Store at 20° to 25°C (68° - 77°F).  [See USP Controlled Room Temperature.]  Protect from excessive moisture. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10237 02/15

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS
30 MG, 60 MG, AND 120 MG
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 Isosorbide mononitrate extended-release tablet, for oral
administration contains 30
mg, 60 mg or 120 mg of ISMN. In addition, each tablet contains the
following inactive
ingredients: carnauba wax, colloidal silicon dioxide, ethylcellulose,
hypromellose, lactose,
magnesium stearate, polyethylene glycol, polysorbate 80, titanium
dioxide. The 30 mg
tablet also contains D&D Red No. 27 aluminum lake, D&C Red No. 30
aluminum lake,
FD&C Blue No. 2 aluminum lake, and FD&C Yellow No. 6 aluminum lake.
The 60 mg
tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No.
2 aluminum
lake.
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).
ISMN is freely soluble in water, ethanol, methanol, chloroform, ethyl
acetate, and
dichloromethane.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
ISMN extended-release tablets are 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
6
9
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veins, especially the latter. Dilatation of the veins promotes
peripheral pooling of blood,
decreases venous return to the heart, thereby reducing le