ISOSORBIDE dinitrate tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE - UNII:WXR179L51S)

Verfügbar ab:

Golden State Medical Supply, Inc.

INN (Internationale Bezeichnung):

ISOSORBIDE DINITRATE

Zusammensetzung:

ISOSORBIDE DINITRATE 5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ISOSORBIDE- ISOSORBIDE DINITRATE TABLET
ISOSORBIDE SUBLINGUAL- ISOSORBIDE DINITRATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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ISOSORBIDE DINITRATE TABLETS, USP (ORAL) ISOSORBIDE DINITRATE TABLETS,
SUBLINGUAL, USP (ORAL)
Rev 04/06
RX ONLY
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol
2,5-dinitrate, an organic nitrate whose
structural formula is:
and whose molecular weight is 236.14. The organic nitrates are
vasodilators, active on both arteries
and veins.
ISDN is a white, crystalline, odorless compound which is stable in air
and in solution, has a melting
point of 70°C and has an optical rotation of +134° (c=1.0, alcohol.
20°C). ISDN is freely soluble in
organic solvents such as acetone, alcohol, and ether, but is only
sparingly soluble in water.
Each isosorbide dinitrate tablet contains either 5 mg, 10 mg, 20 mg or
30 mg of ISDN. Each isosorbide
dinitrate sublingual tablet contains 2.5 mg or 5 mg of ISDN.
Inactive ingredients are as follows:
5 MG AND 10 MG: Ammonium phosphate dibasic, anhydrous lactose,
magnesium stearate,
microcrystalline cellulose, sodium starch glycolate.
20 MG: Ammonium phosphate dibasic, anhydrous lactose, D&C Yellow No.
10 Lake. FD&C Blue No. 1
Lake, FD&C Yellow No. 6 Lake, magnesium stearate, microcrystalline
cellulose, sodium starch
glycolate.
30 MG: Ammonium phosphate dibasic, colloidal silicon dioxide, FD&C
Blue No. 1 Lake, lactose
monohydrate, magnesium stearate and microcrystalline cellulose.
2.5 MG SUBLINGUAL: Ammonium phosphate dibasic, anhydrous lactose, corn
starch, D&C Yellow No. 10
Lake, FD&C Yellow No. 6 Lake, magnesium stearate, microcrystalline
cellulose, sodium starch
glycolate.
5 MG SUBLINGUAL: Ammonium phosphate dibasic, anhydrous lactose,
colloidal silicon dioxide, corn
starch, magnesium stearate, microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The principal pharmacological action of ISDN is relaxation of vascular
smooth muscle and consequent
dilatation of peripheral arteries and veins, especially the latter.
Dilatation of the vein