ISOSORBIDE DINITRATE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NCS HealthCare of KY, LLC dba Vangard Labs

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 is 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.

उत्पाद समीक्षा:

Isosorbide dinitrate Tablets are available as follows: 5 mg, Light pink to pink round tablets, debossed with, “Λ” on one side and score line on the other side.                                                                                          21 10 mg, Light green to green mottled round tablets, debossed with, "Λ" on one side and score line on the other side.                                                                                                            22 Blistercards of 30       NDC 0615-8463-39 20 mg, Light green to green mottled round tablets, debossed with, "Λ" on one side and score line on the other side.                                                                                                            23 Blistercards of 30        NDC 0615-8464-39 30 mg, Light green to green mottled round tablets, debossed with, "Λ" on one side and score line on the other side.                                                                                                            24 Blistercards of 30         NDC 0615-8465-39 40 mg, Light green to green mottled round tablets, debossed with, "Λ" on one side and score line on the other side.                                                                                                            45 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed. Dispense in a light-resistant, tight container. All trademarks are the property of their respective owners. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Distributed by: Advagen Pharma Ltd 666 Plainsboro Road Suite 605Plainsboro, NJ 08536, US Revision: 06/22

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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ISOSORBIDE DINITRATE TABLETS
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 powder compound which is
stable in air and in
solution, has a melting point of 69°C to 72°C and optically active.
Isosorbide dinitrate is
very soluble in acetone, sparingy soluble in alcohol and very slightly
soluble in water.
Each Isosorbide dinitrate tablet contains 5 mg, 10 mg, 20 mg, 30 mg or
40 mg of
isosorbide dinitrate. The inactive ingredients in each tablet are
microcrystalline cellulose,
colloidal silicon dioxide, and magnesium stearate. The 5mg, 10 mg, 20
mg and 30 mg
dosage strengths also contain anhydrous lactose and sodium starch
glycolate Type A.
Additionally 5 mg contains FD & C red 40 Al lake. 10 mg, 20mg, 30 mg
and 40 mg
contains FD & C Blue 1 Al lake and D & C Yellow 10 Al lake.
FDA approved dissolution test specifications differ from USP.
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.
Dosing regimens for most chronically used drugs are designed to
provide plasma
concentrations that are continuously greater than a minimally
e