Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Isosorbide Dinitrate
Generic Name
Isosorbide Dinitrate
Active Ingredient
Isosorbide DinitrateCategory
Nitrate Vasodilator [EPC]
Variants
54
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 40 mg/1 | TABLET | ORAL | 70710-1152 |
| 5 mg/1 | TABLET | ORAL | 72888-081 |
| 5 mg/1 | TABLET | ORAL | 0143-1769 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Isosorbide Dinitrate, you must consult a qualified healthcare professional.
| 20 mg/1 | TABLET | ORAL | 49884-022 |
| 10 mg/1 | TABLET | ORAL | 50268-448 |
| 10 mg/1 | TABLET | ORAL | 68084-082 |
| 30 mg/1 | TABLET | ORAL | 70771-1504 |
| 20 mg/1 | TABLET | ORAL | 16714-009 |
| 5 mg/1 | TABLET | ORAL | 50268-447 |
| 10 mg/1 | TABLET | ORAL | 51407-148 |
| 5 mg/1 | TABLET | ORAL | 68682-193 |
| 10 mg/1 | TABLET | ORAL | 0615-8463 |
+ 38 more variants
Detailed information about Isosorbide Dinitrate
Isosorbide Dinitrate is a potent nitrate vasodilator used primarily for the prevention and treatment of angina pectoris. It works by relaxing vascular smooth muscle to improve blood flow and reduce the heart's workload.
The dosage of Isosorbide Dinitrate must be highly individualized based on the patient's clinical response, the severity of their condition, and their development of nitrate tolerance.
The safety and effectiveness of Isosorbide Dinitrate in pediatric patients (children under 18 years of age) have not been established. It is not currently FDA-approved for use in children. Healthcare providers rarely prescribe this for pediatric use unless in highly specialized cardiac cases under strict supervision.
Because the metabolites of Isosorbide Dinitrate are excreted by the kidneys, patients with severe renal (kidney) impairment may require more frequent monitoring. However, specific dosage adjustment guidelines for renal failure are not strictly defined in the manufacturer's labeling; clinicians usually start with the lowest possible dose.
Since the liver is the primary site of metabolism for Isosorbide Dinitrate, patients with hepatic (liver) insufficiency (such as cirrhosis) may process the drug more slowly. This can lead to higher blood levels and an increased risk of side effects like hypotension (low blood pressure). Dose titration should be performed slowly and with caution.
In geriatric patients (65 years and older), there is a higher risk of orthostatic hypotension (a sudden drop in blood pressure when standing up). Healthcare providers typically start elderly patients on the lowest effective dose and monitor for dizziness and fall risks.
Proper administration is vital for the effectiveness of Isosorbide Dinitrate:
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at once to make up for a missed one, as this significantly increases the risk of severe hypotension.
An overdose of Isosorbide Dinitrate can be life-threatening. Symptoms include:
If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or change your dosing schedule without medical guidance.
The most frequently reported side effect of Isosorbide Dinitrate is the 'nitrate headache.' Because the drug dilates blood vessels throughout the body, it also dilates the vessels in the brain and scalp. This typically presents as a throbbing, persistent headache.
Other common effects include:
Isosorbide Dinitrate is a potent cardiovascular medication that requires careful management. Patients must be aware that while this drug prevents chest pain, it does not cure the underlying coronary artery disease. It must be used as part of a comprehensive treatment plan that includes diet, exercise, and other prescribed medications.
There are currently no FDA black box warnings for Isosorbide Dinitrate. However, the risk of severe, potentially fatal hypotension when combined with certain other drugs is the most significant safety concern associated with this medication.
There is one interaction that is considered absolute and life-threatening:
Isosorbide Dinitrate must NEVER be used in the following circumstances:
Isosorbide Dinitrate is classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, or there are no adequate and well-controlled studies in humans.
It is not known whether Isosorbide Dinitrate or its metabolites are excreted in human milk. Because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants (such as low blood pressure), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Isosorbide Dinitrate is a prodrug that acts as an exogenous source of nitric oxide (NO). The molecular mechanism involves the following steps:
Common questions about Isosorbide Dinitrate
Isosorbide Dinitrate is primarily used to prevent and treat angina pectoris, which is chest pain caused by a lack of oxygen to the heart muscle. It is available in fast-acting sublingual forms for immediate relief of an attack and long-acting oral forms for daily prevention. Additionally, it is sometimes used in combination with other medications like hydralazine to treat chronic heart failure. It works by relaxing the blood vessels, which reduces the workload on the heart and improves blood flow. This medication is a cornerstone for patients with stable coronary artery disease who continue to have symptoms despite other treatments. Your healthcare provider will determine the best formulation based on whether you need immediate relief or long-term prevention.
The most common side effect of Isosorbide Dinitrate is a throbbing headache, often referred to as a 'nitrate headache.' This occurs because the medication dilates blood vessels in the head as well as the heart. Other frequent side effects include dizziness, lightheadedness, and flushing of the face and neck. Some patients may also experience a rapid heartbeat or a temporary drop in blood pressure when standing up too quickly. Most of these side effects, especially the headache, tend to improve or disappear after a week or two as your body adjusts to the medicine. If side effects are severe or do not go away, you should consult your healthcare provider for management strategies.
It is strongly recommended that you avoid or strictly limit alcohol consumption while taking Isosorbide Dinitrate. Both alcohol and Isosorbide Dinitrate act as vasodilators, meaning they both widen your blood vessels and lower your blood pressure. When taken together, their effects are additive, which can lead to a dangerously large drop in blood pressure. This can result in severe dizziness, fainting, or even a cardiovascular collapse in sensitive individuals. Furthermore, alcohol can increase the severity of the headaches associated with nitrate therapy. Always discuss your alcohol intake with your doctor to understand the specific risks for your situation.
Isosorbide Dinitrate is classified as FDA Pregnancy Category C, meaning there is limited data on its safety in pregnant women. Animal studies have shown some potential for harm, primarily due to the mother's blood pressure dropping and reducing blood flow to the fetus. There are no well-controlled studies in humans to confirm its safety or risks during pregnancy. Therefore, it is typically only prescribed during pregnancy if the potential benefits to the mother clearly outweigh the potential risks to the baby. If you are pregnant or planning to become pregnant, you must discuss alternative treatments with your cardiologist. Breastfeeding is also generally not recommended while taking this medication as it is unknown if it passes into breast milk.
The onset of action for Isosorbide Dinitrate depends entirely on the formulation you are using. Sublingual tablets, which are placed under the tongue, work very quickly, usually providing relief within 2 to 5 minutes. This makes them ideal for treating an acute attack of chest pain. Immediate-release oral tablets typically take 20 to 40 minutes to begin working and are used for ongoing prevention rather than immediate relief. Extended-release versions take even longer to reach peak levels but provide a sustained effect over several hours. Always use the specific form your doctor prescribed for the intended purpose—never use an oral tablet to treat an emergency chest pain event.
No, you should never stop taking Isosorbide Dinitrate suddenly without consulting your healthcare provider. Abruptly discontinuing this medication can cause a 'rebound effect,' where your chest pain (angina) returns more frequently or more severely than before. In some cases, stopping the drug suddenly can even trigger a heart attack in patients with severe coronary artery disease. If the medication needs to be stopped due to side effects or a change in treatment, your doctor will provide a schedule to gradually taper the dose. This allows your blood vessels to slowly adjust to the absence of the medication. Always ensure you have an adequate supply of your medication so you do not run out unexpectedly.
If you miss a dose of Isosorbide Dinitrate, you should take it as soon as you remember. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and continue with your regular dosing schedule. It is vital that you do not take two doses at the same time to 'catch up,' as this can cause a dangerous drop in blood pressure and severe side effects. Maintaining your regular schedule is important for the drug's effectiveness and to ensure you maintain your required nitrate-free interval. If you frequently miss doses, consider using a pill organizer or setting an alarm to help you stay on track. Consult your pharmacist if you have questions about your specific dosing schedule.
Isosorbide Dinitrate is not known to cause weight gain as a direct side effect. It does not affect your metabolism, appetite, or fat storage in a way that would lead to increased body weight. If you notice rapid weight gain or swelling in your ankles and feet while taking this medication, it could be a sign of worsening heart failure rather than a side effect of the drug itself. In such cases, you should contact your healthcare provider immediately, as this may require a change in your overall heart treatment plan. Always monitor your weight regularly if you have a heart condition. Maintaining a healthy weight is an important part of managing the conditions for which this drug is prescribed.
Isosorbide Dinitrate can interact with many other medications, so it is crucial to provide your doctor with a full list of everything you take. It is absolutely contraindicated with PDE5 inhibitors like Viagra or Cialis, as the combination can cause a fatal drop in blood pressure. It should also be used cautiously with other blood pressure medications, as the combined effect can lead to excessive hypotension. Some antidepressants and antipsychotics can also increase the risk of dizziness when taken with nitrates. Even over-the-counter supplements like St. John's Wort or Arginine can potentially interfere with how the drug works. Your doctor will carefully review your medications to ensure that Isosorbide Dinitrate is a safe addition to your regimen.
Yes, Isosorbide Dinitrate is widely available as a generic medication in various strengths and formulations. The generic versions are bioequivalent to the brand-name versions (such as Isordil) and are typically much more cost-effective for patients. Both the sublingual and oral immediate-release tablets are available generically. Because it has been on the market for several decades, it is generally covered by almost all insurance plans and Medicare Part D. When filling your prescription, your pharmacist may provide the generic version unless your doctor specifically requests the brand name. Generic Isosorbide Dinitrate meets the same FDA standards for quality and effectiveness as the original brand-name drug.
Other drugs with the same active ingredient (Isosorbide Dinitrate)
> Warning: Stop taking Isosorbide Dinitrate and call your doctor immediately if you experience any of the following:
The primary concern with long-term use of Isosorbide Dinitrate is the development of nitrate tolerance. When the body is exposed to nitrates continuously, the blood vessels stop responding to the drug. This is not a 'side effect' in the traditional sense, but a physiological adaptation that renders the medication ineffective. To avoid this, a nitrate-free interval is mandatory.
There is also some clinical evidence suggesting that long-term nitrate therapy may increase 'oxidative stress' within the blood vessels, which could potentially contribute to the progression of underlying cardiovascular disease if not managed alongside other therapies like ACE inhibitors or statins.
No FDA black box warnings currently exist for Isosorbide Dinitrate. However, the contraindication regarding its use with PDE5 inhibitors (like Viagra) is considered a 'major warning' that carries the same clinical weight as a black box warning in practice.
Report any unusual symptoms or changes in your health to your healthcare provider immediately. Regular follow-up appointments are necessary to ensure the medication remains safe and effective for you.
Patients taking Isosorbide Dinitrate do not typically require frequent blood tests for the drug itself, but they do require regular monitoring of:
Isosorbide Dinitrate can cause dizziness, lightheadedness, and blurred vision, especially during the first few weeks of treatment or after a dose increase. Patients should not drive, operate heavy machinery, or perform dangerous tasks until they know how the medication affects them.
Alcohol should be strictly avoided or severely limited while taking Isosorbide Dinitrate. Alcohol is also a vasodilator. Combining the two can lead to a 'double' effect, causing a dangerous drop in blood pressure, severe dizziness, and fainting.
Do not stop taking Isosorbide Dinitrate suddenly. Abruptly halting the medication can lead to 'rebound angina,' where chest pain attacks become more frequent or more severe than they were before starting the drug. If the medication needs to be stopped, your healthcare provider will provide a tapering schedule to slowly reduce the dose.
> Important: Discuss all your medical conditions, including any history of low blood pressure or glaucoma, with your healthcare provider before starting Isosorbide Dinitrate.
Isosorbide Dinitrate may interfere with the Zlatkis-Zak color reaction, which is used to measure serum cholesterol levels, potentially resulting in falsely low readings. It does not typically affect standard blood counts or liver/kidney function tests.
For each major interaction, the primary management strategy is avoidance (in the case of PDE5 inhibitors) or cautious dose titration and monitoring (in the case of other blood pressure medications).
> Important: Tell your doctor about ALL medications, supplements, vitamins, and herbal products you are taking, as well as any recreational drug use.
These are conditions where the drug should be used only if the benefits clearly outweigh the risks, and only under very close supervision:
Patients who are allergic to one type of organic nitrate (such as Nitroglycerin or Isosorbide Mononitrate) are almost certain to be allergic to Isosorbide Dinitrate. There is a 100% cross-sensitivity within this drug class. There is no known cross-sensitivity between nitrates and other classes of heart medications like ACE inhibitors or Beta-blockers.
> Important: Your healthcare provider will evaluate your complete medical history, including any rare conditions, before prescribing Isosorbide Dinitrate.
As previously noted, Isosorbide Dinitrate is not approved for use in patients under 18. The safety profile and appropriate dosing for children have not been established through clinical trials. In rare cases of pediatric heart failure, it may be used off-label by pediatric cardiologists, but this is not standard practice.
Clinical studies of Isosorbide Dinitrate did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. However, clinical experience suggests several concerns:
In patients with kidney disease, the clearance of the active metabolites (Isosorbide-5-mononitrate) may be reduced. While standard dose adjustments are not always required for mild-to-moderate impairment, patients with a GFR (Glomerular Filtration Rate) below 30 mL/min should be monitored closely for signs of nitrate toxicity.
Since the liver is the primary site for the 'first-pass' metabolism of ISDN, patients with Child-Pugh Class B or C hepatic impairment may have significantly higher plasma concentrations of the drug. This increases the risk of side effects. Clinicians typically start at the lowest dose and titrate very slowly.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
| Parameter | Value |
|---|---|
| Bioavailability | ~25% (Oral due to first-pass); ~40-50% (Sublingual) |
| Protein Binding | ~28% |
| Half-life (Parent) | ~1 hour |
| Half-life (5-Mononitrate) | ~5 hours |
| Tmax (Oral) | 30 - 60 minutes |
| Metabolism | Hepatic (Denitration) |
| Excretion | Renal (>95% as metabolites) |
Isosorbide Dinitrate is a Nitrate Vasodilator. It is closely related to Nitroglycerin (Glyceryl Trinitrate) and Isosorbide Mononitrate. While all three share the same mechanism, Isosorbide Dinitrate is often preferred for long-term prophylaxis over nitroglycerin due to its longer duration of action.