ISOSORBIDE DINITRATE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Northstar Rx LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use isosorbide dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

產品總結:

Isosorbide dinitrate tablets, USP are available as follows: Isosorbide dinitrate tablets USP, 5 mg, light pink to pink colored, spotted, round shaped, biconvex, uncoated tablets debossed with "1148" on one side and score on other side. NDC 16714-007-01 in bottles of 100 tablets with child-resistant closure Isosorbide dinitrate tablets USP, 10 mg, white to off white colored, round shaped, biconvex, uncoated tablets debossed with "1149" on one side and score on other side. NDC 16714-008-01 in bottles of 100 tablets with child-resistant closure Isosorbide dinitrate tablets USP, 20 mg, light green to green colored, spotted, round shaped, biconvex, uncoated tablets debossed with "1150" on one side and score on other side. NDC 16714-009-01 in bottles of 100 tablets with child-resistant closure Isosorbide dinitrate tablets USP, 30 mg, light blue to blue colored, spotted, round shaped, biconvex, uncoated tablets debossed with "1151" on one side and score on other side. NDC 16714-010-01 in bottles of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light. Dispense in a light-resistant, tight container. Keep bottles tightly closed. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Zydus Lifesciences Ltd., Baddi, India Rev. 09/22

授权状态:

Abbreviated New Drug Application

产品特点

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
NORTHSTAR RX LLC
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ISOSORBIDE DINITRATE TABLETS, USP
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.
Isosorbide dinitrate is a white, crystalline compound, has a melting
point of 70°C and
has an optical rotation of +140° (c=1, alcohol, 20°C). Isosorbide
dinitrate is very slightly
soluble in water; very soluble in acetone and sparingly soluble in
alcohol.
Each isosorbide dinitrate tablet, USP contains 5 mg, 10 mg, 20 mg or
30 mg of
isosorbide dinitrate. The inactive ingredients in each tablet are
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, povidone and sodium
starch glycolate.
The 5 mg dosage strength also contains FD&C red no. 40 aluminium lake.
The 20 mg
dosage strength also contains FD&C blue no. 1 aluminium lake and D&C
yellow no. 10
aluminium lake. The 30 mg dosage strength also contains FD&C blue no.
1 aluminium
lake.
CLINICAL PHARMACOLOGY
The principal pharmacological action of isosorbide dinitrate is
relaxation of vascular
smooth muscle and consequent dilatation of peripheral arteries and
veins, especially the
latter. Dilatation 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.
reduction, afterload reduction, and coronary dilatation remains
undefined.
Dosing regimens for most chronically used drugs are designed to
provide plasma
concentrations that are continuously greater than a minimally
e