Isosorbide Dinitrate — uses, dosing, side effects & the brands that sell it · pharmaranks
Isosorbide Dinitrate: uses, dosing, side effects & brands
Isosorbide Dinitrate is a nitrate vasodilator sold in the U.S. under 3 brand and generic names, for angina pectoris, coronary disease and cyanosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Nitrate Vasodilator
Treats
Angina Pectoris, Coronary Disease and Cyanosis
Available as
Capsule, extended release · Tablet
Sold as
3 products — Dilatrate-SR, Isordil and Sorbitrate
Prescription?
Prescription only
Generic available?
Not in our catalog
Typical price
about $6 for a 30-count supply
How isosorbide dinitrate is dosed
From the FDA label for Dilatrate-SR (application NDA019790). Other isosorbide dinitrate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
As noted under CLINICAL PHARMACOLOGY , 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 CLINICAL PHARMACOLOGY , 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 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 side effects
to isosorbide dinitrate are generally dose-related, and almost all of these reactions are the result of isosorbide dinitrate's 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 OVERDOSAGE ). Data are not available to allow estimation of the frequency of adverse reactions during treatment with isosorbide dinitrate tablets.
Every isosorbide dinitrate product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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 10 mg of isosorbide dinitrate. The inactive ingredients in each tablet are microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 10 mg dosage strength also contains anhydrous lactose and sodium starch glycolate Type A. Additionally, 10 mg contains FD & C Blue 1 Al lake and D & C Yellow 10 Al lake. FDA approved dissolution test specifications differ from USP. Isosorbide Dinitrate Chemical Structure
What kind of drug is isosorbide dinitrate?
The FDA classifies isosorbide dinitrate as a nitrate vasodilator. Nitrate vasodilators are converted in the body into nitric oxide, which relaxes the smooth muscle in blood vessel walls and widens them. This mainly opens up the veins, reducing how hard the heart must work and relieving chest pain. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take isosorbide dinitrate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run isosorbide dinitrate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is isosorbide dinitrate sold under?
We track 3 isosorbide dinitrate-containing products in the U.S.: Dilatrate-SR, Isordil and Sorbitrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take isosorbide dinitrate
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.
Isosorbide Dinitrate drug interactions
The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ).
Across the brands we track, isosorbide dinitrate is currently marketed as capsule, extended release and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic isosorbide dinitrate?
We do not currently list a generic-labelled isosorbide dinitrate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.