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Isosorbide
Overview
What is Isosorbide?
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 5 mg, 10 mg, or 20 mg of ISDN.
Inactive ingredients are as follows:
5 mg and 10 mg:
20 mg:
What does Isosorbide look like?
What are the available doses of Isosorbide?
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What should I talk to my health care provider before I take Isosorbide?
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How should I use Isosorbide?
Isosorbide dinitrate oral tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral ISDN is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
As noted under , multiple 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 oral 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 oral 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 oral 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.
What interacts with Isosorbide?
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients.
What are the warnings of Isosorbide?
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
Amplification of the vasodilatory effects of ISDN 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
What are the precautions of Isosorbide?
General:
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to ISDN develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.
Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the daily dose-free interval in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and exercise tolerance. The importance of these observations to the routine, clinical use of sublingual and immediate-release oral ISDN is not known.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Information for Patients:
Treatment with ISDN may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.
Drug Interactions:
Carcinogenesis. Mutagenesis. Impairment of Fertility:
Pregnancy Category C:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
What are the side effects of Isosorbide?
Adverse reactions to ISDN are generally dose-related, and most all of these reactions are the result of ISDN'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 ).
Data are not available to allow estimation of the frequency of adverse reactions during treatment of isosorbide dinitrate oral tablets.
What should I look out for while using Isosorbide?
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients.
Amplification of the vasodilatory effects of ISDN 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
What might happen if I take too much Isosorbide?
How should I store and handle Isosorbide?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.Isosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyIsosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769".Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side.Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side.They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths:2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacokinetics:
Once absorbed, the distribution volume of ISDN is 2 to 4 L/kg, and this volume is cleared at the rate of 2 to 4 L/min, so ISDN's half-life in serum is about an hour. Since the clearance exceeds hepatic blood flow, considerable extrahepatic metabolism must also occur. Clearance is affected primarily by denitration to the 2-mononitrate (15 to 25%) and the 5-mononitrate (75 to 85%).
Both metabolites have biological activity, especially the 5-mononitrate. With an overall half-life of about 5 hours, the 5-mononitrate is cleared from the serum by denitration to isosorbide; glucuronidation to the 5-mononitrate glucuronide; and denitration/hydration to sorbitol. The 2-mononitrate has been less well studied, but it appears to participate in the same metabolic pathways, with a half-life of about 2 hours.
The daily dose-free interval sufficient to avoid tolerance to organic nitrates has not been well defined. Studies of nitroglycerin (an organic nitrate with a very short half-life) have shown that daily dose-free intervals of 10 to 12 hours are usually sufficient to minimize tolerance. Daily dose-free intervals that have succeeded in avoiding tolerance during trials of moderate doses ( 30 mg) of immediate-release ISDN have generally been somewhat longer (at least 14 hours), but this is consistent with the longer half-lives of ISDN and its active metabolites.
Few well-controlled clinical trials of organic nitrates have been designed to detect rebound or withdrawal effects. In one such trial, however, subjects receiving nitroglycerin had exercise tolerance at the end of the daily dose-fiee interval than the parallel group receiving placebo. The incidence, magnitude, and clinical significance of similar phenomena in patients receiving ISDN have not been studied.
Non-Clinical Toxicology
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients.Amplification of the vasodilatory effects of ISDN 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Drug Interactions:
General:
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to ISDN develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.
Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the daily dose-free interval in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and exercise tolerance. The importance of these observations to the routine, clinical use of sublingual and immediate-release oral ISDN is not known.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Adverse reactions to ISDN are generally dose-related, and most all of these reactions are the result of ISDN'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 ).
Data are not available to allow estimation of the frequency of adverse reactions during treatment of isosorbide dinitrate oral tablets.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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