Isosorbide Dinitrate (Isosorbide Dinitrate)

Trade Name : Isosorbide Dinitrate

Hikma Pharmaceuticals USA Inc.

TABLET

Strength 5 mg/1

ISOSORBIDE DINITRATE Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Isosorbide Dinitrate (Isosorbide Dinitrate) which is also known as Isosorbide Dinitrate and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 5 mg/1 per ml. Read more

Isosorbide Dinitrate (Isosorbide Dinitrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Rev. 01/19
Rx Only

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, odorless compound which is stable in air and in solution, has a melting point of 70u00b0C and has an optical rotation of + 134u00b0 (c=1.0, alcohol, 20u00b0C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water.
Each Isosorbide Dinitrate Tablet, USP contains 5 mg, 10 mg, or 20 mg of isosorbide dinitrate.
Inactive ingredients are as follows:
5 mg and 10 mg:
20 mg:

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 effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were no more effective than placebo after 24 hours (or less) of continuous therapy. Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their anti-anginal efficacy been restored.

Isosorbide Dinitrate Tablets, USP 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 other ingredients.
Do not use isosorbide dinitrate tablets 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 tablets in patients who are taking soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Amplification of the vasodilatory effects of isosorbide dinitrate tablets by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of immediate-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.

No data

Adverse reactions to isosorbide dinitrate are generally dose-related, and almost all of these reactions are the result of isosorbide dinitrateu2019s activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see ).
Data are not available to allow estimation of the frequency of adverse reactions during treatment with isosorbide dinitrate tablets.
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

As noted under n multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for isosorbide dinitrate tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.
As also noted under , the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.
Large controlled studies with other nitrates suggest that no dosing regimen with isosorbide dinitrate tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate tablets is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.

Isosorbide Dinitrate Tablets, USP 5 mg: White, Round, Scored Tablets Debossed u201cWest-ward 769u201d.
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bottles of 100 tablets u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-1769-01
Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed u201cWWu201d on one side and u201c771u201d on the other side.
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bottles of 100 tablets u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-1771-01
Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed u201cWWu201d on one side and u201c772u201d on the other side.
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bottles of 100 tablets u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0NDC 0143-1772-01
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Manufactured by:n n P.O. Box 182400Amman 11118 u2013 Jordan
Distributed by:n n Eatontown, NJ 07724 USA
Revised January 2019

NDC 0143-1769-01Isosorbide Dinitrate Tablets, USP 5 mg 100 Tablets Rx Only

NDC 0143-1771-01Isosorbide Dinitrate Tablets, USP10 mg 100 Tablets Rx Only

NDC 0143-1772-01Isosorbide Dinitrate Tablets, USP 20 mg 100 Tablets Rx Only

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Isosorbide Dinitrate (Isosorbide Dinitrate)

Trade Name : Isosorbide Dinitrate

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Isosorbide Dinitrate (Isosorbide Dinitrate)

Trade Name : Isosorbide Dinitrate

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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