Imdur sustained-release tablets

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Imdur sustained-release tablets

What is Imdur sustained-release tablets?

Imdur sustained-release tablets contain the active ingredient isosorbide mononitrate. This medication belongs to a class of drugs known as nitrates, which are primarily used to manage certain heart conditions.

Mechanism of Action

Isosorbide mononitrate works by relaxing the smooth muscles within the walls of blood vessels. This relaxation leads to the widening of the veins and arteries, a process called vasodilation. By expanding the blood vessels, the medication reduces the workload on the heart, as it becomes easier for the heart to pump blood throughout the body. Additionally, vasodilation improves the flow of blood and oxygen to the heart muscle itself.

Therapeutic Use

Imdur is specifically designed for the long-term prevention of angina pectoris. Angina is chest pain or discomfort that occurs when a part of the heart muscle does not receive enough oxygen-rich blood.

The tablets are formulated as a sustained-release preparation. This means the active ingredient is released gradually into the bloodstream over an extended period. Because of this slow-release mechanism, the medication provides a steady effect throughout the day, making it suitable for preventing chest pain rather than providing immediate relief during an acute attack.

Product Characteristics

  • Active Ingredient: Isosorbide mononitrate.
  • Formulation: Sustained-release (extended-release) tablets.
  • Primary Function: Prophylactic treatment of angina pectoris.

Regulatory References

  1. National Institutes of Health (NIH)

What side effects are possible with Imdur sustained-release tablets?

Official Adverse Reactions and Safety Profile

The safety profile of Isosorbide Mononitrate sustained-release tablets is officially documented by government regulatory agencies, classifying potential effects based on frequency and the physiological systems involved. All listed effects are derived from regulatory labeling and prescribing information.

Frequency Classification of Adverse Reactions

Adverse reactions are grouped by their reported incidence rate based on standardized regulatory classifications:

Frequency Category Associated Adverse Reactions
Very Common (ge 1/10) Headache
Common (ge 1/100 to <1/10) Dizziness, Nausea, Vomiting
Uncommon (ge 1/1,000 to <1/100) Transient Hypotension, Syncope, Rash, Pruritus
Very Rare (<1/10,000) Angioedema

System-Organ Classes and Serious Reactions

The most frequently reported effects, Headache, Dizziness, Nausea, and Vomiting, involve the Nervous and Gastrointestinal Systems. Reactions affecting the Vascular System, such as Hypotension (low blood pressure) and Syncope (fainting), carry the potential for clinical seriousness, with Severe Hypotension and circulatory collapse being officially documented as serious adverse reactions.

Safety Considerations and Restrictions

Official labeling defines specific safety constraints. Use is contraindicated in patients with pre-existing conditions such as severe hypotension or cardiogenic shock. A mandatory restriction is placed on the concomitant use with Phosphodiesterase Type 5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil) due to the risk of profound, life-threatening hypotension.

Regarding timing, the Headache reaction is noted as being most pronounced at the start of treatment and typically subsides with continued administration. Furthermore, regulatory documents state that the safety and effectiveness of the medicine have not been established in pediatric patients and older patients may exhibit greater sensitivity to its effects.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Isosorbide Mononitrate is officially documented in regulatory labeling as presenting with signs of severe, excessive vasodilation. Common manifestations listed include profound hypotension (severely low blood pressure), a persistent throbbing headache, dizziness, flushing, and syncope (fainting). Severe gastrointestinal effects such as nausea and vomiting are also described.

Overdosage may escalate to severe or life-threatening cardiocirculatory compromise, potentially resulting in circulatory collapse or failure. A critical outcome listed in regulatory labeling is Methemoglobinemia, a condition affecting blood oxygen capacity that can be signaled by cyanosis, and in severe cases, neurological effects such as convulsions or coma.

Regulators uniformly mandate that individuals must seek immediate medical attention upon any suspicion of overdose. Emergency services or a Poison Control Center must be contacted at once, particularly if severe signs such as collapse, seizures, or difficulty breathing are present. Treatment is broadly symptomatic and supportive, as the labeling states that no specific antidote is known for the nitrate compound itself. However, specific interventions are described, including measures to increase central fluid volume to manage severe hypotension and the use of Methylene Blue for documented Methemoglobinemia. Hospitalization and continuous monitoring of vital signs are required for observation and management.

Therapeutic Uses of Imdur sustained-release tablets

What Imdur sustained-release tablets treats: main uses and benefits

The primary therapeutic domain for this long-acting medication is the management and prevention of angina pectoris caused by coronary artery disease (CAD). The medication is generally applied across domains where additional symptomatic support is needed for chronic heart conditions. It is used in situations involving recurrent or episodic manifestations of chest pain.

Prophylactic Management of Chronic Stable Angina

This is a scheduled, long-term maintenance therapy used to manage the established, predictable patterns of cardiac chest pain in adults. Its goal is to provide continuous antianginal support that supports the management of symptomatic aspects of CAD, a condition marked by increased physiological stress. This approach is commonly used when functional stability becomes affected by the threat of recurring symptoms. Key therapeutic applications may assist with managing Chronic Stable Angina, prevention of recurrent cardiac chest pain, and may assist with easing effort-induced symptoms.

“This treatment is relevant in contexts involving heightened systemic burden and may help patients cope more steadily with symptom fluctuations.”

Control Over Angina Attack Frequency and Severity

The sustained-release formulation is used to address the symptom cluster of recurrent cardiac chest pain by minimizing the frequency and reducing the intensity of anginal episodes over time. This provides support that helps ease the overall symptom burden and may help patients cope more steadily with symptom fluctuations, particularly those triggered by physical activity or emotional tension. It is crucial to note that this therapy is not appropriate for immediate relief of an acute anginal episode that has already started.


Quick Fact: Relief for Recurrent Cardiac Chest Pain

Property Description
Main Indication Chronic Stable Angina Pectoris
Type of Relief Prophylactic (Preventative)
Primary Benefit Reduction in Angina Attack Frequency
Usage Context Long-term Maintenance Therapy

Eligibility and Restrictions for Use

Official Eligibility for Imdur Sustained-Release Tablets

Regulatory documents define specific populations who are permitted or prohibited from using Imdur sustained-release tablets (Isosorbide Mononitrate). The medicine is primarily indicated for use in adults for the prophylactic management of chronic stable angina pectoris.


Populations Who Must Not Use Imdur (Contraindications)

Official labeling strictly contraindicates use in patients who have a known hypersensitivity to nitrates or those who are concurrently taking Phosphodiesterase type 5 (PDE5) inhibitors (like sildenafil) or Soluble Guanylate Cyclase (sGC) Stimulators (like riociguat). The medicine is also prohibited for patients experiencing acute circulatory failure or those with severe anemia.


Eligibility Restrictions by Age and Condition

  • Pediatric Use: The safety and effectiveness have not been established in pediatric patients (under 18 years); therefore, use is not recommended in this age group.
  • Pregnancy and Lactation: Use during pregnancy is advised only if clearly needed, and use is generally not recommended while breastfeeding due to unknown excretion into human milk.
  • Conditional Use: Special caution is required for use in patients with Hypertrophic Obstructive Cardiomyopathy (HOCM) or those with severe hypotension. No specific dosage adjustments or contraindications are typically documented for patients with renal or hepatic impairment.

What should I know about interactions with other medicines?

Official Interaction Restrictions

Co-administration of Isosorbide Mononitrate (Imdur) is strictly regulated for certain drug combinations due to the potential for severe, sudden drops in blood pressure. The following combinations are absolutely contraindicated:

  • Phosphodiesterase Type 5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil, vardenafil). This restriction exists because these medicines may significantly potentiate the vasodilatory effect of the nitrate, leading to severe hypotension and cardiovascular complications.
  • Riociguat, a soluble guanylate cyclase stimulator. This is also prohibited due to the risk of additive hypotensive effects.

Interactions Affecting Blood Pressure

The official drug labels document interactions resulting from additive pharmacodynamic effects:

  • Antihypertensive Agents: Co-administration with other medicines intended to lower blood pressure, including beta-blockers, calcium channel blockers, and diuretics, may result in additive hypotensive effects. Patients using these combinations must be observed for excessive blood pressure reduction.
  • Other Agents: The hypotensive effects may also be potentiated when co-administered with certain major tranquilizers (Phenothiazines) and tricyclic antidepressants.
  • Alcohol: The consumption of alcohol is noted to cause an additive vasodilatory effect, which can increase the risk of dizziness and fainting.
  • Food: The rate or extent of absorption of the sustained-release tablet is not significantly affected when taken with food.

Population-Specific Cautions

Regulatory information notes that elderly patients and individuals with marked hepatic or renal insufficiency may have an increased susceptibility to the hypotensive effects resulting from these documented interactions.

Mechanism of Action

The drug's mechanism initiates with the active ingredient, Isosorbide Mononitrate (ISMN), functioning as a prodrug that undergoes bioactivation to release the gaseous molecule Nitric Oxide (NO). This NO acts as the primary molecular mediator, binding to and activating the enzyme soluble Guanylate Cyclase (sGC) inside vascular smooth muscle cells. The activation of sGC sharply elevates the intracellular concentration of the second messenger cyclic Guanosine Monophosphate (cGMP), initiating a cascade that results in the dephosphorylation of myosin light chains and subsequent muscle fiber relaxation.

This molecular cascade produces generalized vasodilation, preferentially increasing venous capacitance over arterial dilation. The resulting blood pooling in the periphery functionally decreases the volume of blood returning to the heart (reduced preload). This key physiological adjustment lessens wall tension on the myocardium, leading to decreased oxygen requirements of the heart muscle.

However, the mechanism is subject to nitrate tolerance (tachyphylaxis), where continuous exposure diminishes vascular responsiveness. The reliance on a gradual bioactivation process means the mechanism's onset is too slow to rapidly modulate sudden physiological events, limiting its utility to sustained pathway modulation.

Dosage and Administration Information

How to use Imdur sustained-release tablets

The administration of Imdur sustained-release tablets is a structured, once-daily oral protocol. As a long-acting preparation, it is crucial that the tablets are swallowed whole with a fluid, such as water, and must not be crushed or chewed to preserve the controlled-release mechanism. The medicine may be taken independently of meals.

Official Administration Principles

Principle Guideline
Route and Form Oral administration only as a sustained-release tablet.
Frequency and Timing Must be taken once daily (QD), specifically in the morning on arising.
Core Usage Protocol The once-daily schedule is required to ensure a daily nitrate-free interval, a necessary period of low drug concentration in the body to prevent the development of drug tolerance.

Treatment typically begins with a starting dose of 30 mg or 60 mg once daily. In some cases, a 30 mg dose may be used for a few days to minimize initial adverse effects before escalating to a maintenance dose. The usual maintenance dose ranges from 60 mg to 120 mg once daily. Dosing regimens may vary; the maximum recommended daily dose generally does not exceed 120 mg, though rare increases up to 240 mg may be permitted. Dose adjustments should be made gradually, often waiting several days between changes.

Regarding specific populations, guidelines indicate that no routine dosage adjustment is typically required for older adults. Furthermore, the safety and effectiveness of this medicine have not been established for use in pediatric patients.

Recent Clinical Evidence

Recent Clinical Evidence

Evaluation of Isosorbide Mononitrate Therapy

Research designed trials to investigate the use of isosorbide mononitrate (the active ingredient in Imdur) in patients experiencing symptoms of angina pectoris. Studies evaluated changes in exercise tolerance, frequency of anginal episodes, and patient quality of life (QoL) compared to placebo.

Key Findings from Clinical Trials

One randomized, placebo-controlled trial measured the time to onset of anginal pain during exercise over several weeks of treatment. This trial examined the drug's use as a prophylactic treatment—meaning it was intended to help prevent anginal episodes rather than treat an acute attack.

Studies focused on daily dosing regimens designed to maintain therapeutic concentrations while minimizing the risk of nitrate tolerance (reduced drug effectiveness with continuous use). The specific formulation of sustained-release tablets was studied to support a 24-hour effect while enabling a necessary nitrate-free interval.

Limitations and Comparisons

Clinical evidence often highlights the importance of the nitrate-free interval, where a patient is instructed not to take the drug for a portion of the day, typically overnight, to maintain its efficacy over time. This dosing strategy was the primary focus of the clinical program.

While multiple studies support the intended use, direct, long-term comparisons of Imdur against newer anti-anginal medications are limited. Furthermore, research focused specifically on pregnant or breastfeeding participants is not widely reported, meaning evidence is limited in these populations.

Frequently Asked Questions (FAQ)

Common questions about Imdur sustained-release tablets (FAQ)

Q: How is Imdur different from a quick-acting heart tablet?

A: Official product information describes Imdur as a long-acting preparation intended for the prevention of chronic chest pain (angina). Its design is not intended to treat an acute attack that has already started. Because the medicine works slowly to build up a sustained effect, it will not relieve acute symptoms.

Q: Does Imdur help prevent future heart problems?

A: The medicine is officially indicated for the prevention of angina pectoris, a symptom of coronary artery disease. Regulatory documents do not state whether Imdur helps prevent major cardiovascular events, such as heart attacks, that are separate from managing chronic angina symptoms.

Q: What does the "sustained-release" part of Imdur mean for patients?

A: The sustained-release design means the active ingredient is released into the body gradually over an extended period. This design is intended to provide a long-term antianginal effect that lasts for many hours. This effect supports the requirement for once-daily dosing and allows for a necessary drug-free interval each day.

Q: If I miss a dose, what is the official advice?

A: The official advice states that if a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for your next scheduled dose, the missed dose should be skipped entirely. You should not take two doses at the same time to make up for a missed one.

Q: Is the empty shell of the tablet supposed to appear in my stool?

A: The official product information notes that it is possible for an empty tablet shell to appear in your stool. This occurrence is generally understood to be without harm. It is a result of the controlled-release technology, as the body has already absorbed the medicine from the shell.

Q: Can I drink coffee while taking Imdur?

A: Some patient warnings note that limiting the consumption of beverages like coffee and tea may be a strategy to manage common side effects. This is because caffeine may contribute to a common adverse reaction associated with the medication, such as flushing of the face.

Q: Are there any known long-term side effects of taking Imdur?

A: Regulatory documents note that in industrial settings with high, continuous nitrate exposure, tolerance (reduced effectiveness) has developed. The potential for dependence and withdrawal issues have been noted in these settings, though the specific relevance to routine clinical use is not fully defined in the label.

Q: Can Imdur affect how I drive or operate machinery?

A: This medicine may cause common side effects such as headache, blurred vision, dizziness, or tiredness. The official caution indicates that driving or operating machinery should be avoided until patients are certain they are not affected by these side effects.

Q: Are there any signs that a side effect is serious?

A: According to official regulatory information, signs of serious side effects include worsening chest pain or symptoms of an allergic reaction, such as swelling of the face, throat, or difficulty breathing. Other severe effects documented include fainting (syncope) and having a fast or irregular heartbeat.

Q: Can Imdur cause problems with sleeping?

A: Official detailed adverse reaction lists report that some users have experienced difficulty sleeping, which is medically known as insomnia, or have experienced disturbed sleep. Additionally, feelings of unusual drowsiness (somnolence) are also reported.

Q: Can Imdur affect sexual function?

A: The detailed adverse reaction tables for the active ingredient list both decreased libido and impotence as possible effects of the medicine.

Q: Is it safe to take pain relievers like ibuprofen with Imdur?

A: Official sources report that paracetamol is typically acceptable to use with this medicine. However, warnings exist against the regular use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Regulatory sources indicate that frequent use of NSAIDs may potentially worsen angina or heart failure.

Q: Can Imdur interact with herbal supplements?

A: Official information indicates that there is generally not enough safety data available to confirm the safety of combining complementary medicines, herbal remedies, or supplements with isosorbide mononitrate.

Q: Should I tell my dentist I am taking Imdur?

A: Official patient information contains a recommendation to inform any healthcare professional you visit—including doctors, dentists, or pharmacists—that you are taking this medicine. This is especially important if you are having any surgery, including dental surgery.

Q: How long does it typically take for Imdur to start working?

A: The official label confirms that the action of the medicine is not rapid enough to treat an acute attack. Antianginal activity has been demonstrated in clinical trials after both the first dose and after several weeks of continuous dosing.

Q: Is Imdur a medication I will need to take forever?

A: Regulatory documents indicate that this is a treatment intended for a long time to reduce angina attacks. The information suggests that treatment duration is variable and that a clinical decision is required to determine the appropriate method for stopping treatment.

Q: What is the success rate described in the research for Imdur?

A: Clinical trials demonstrated a statistically significant increase in total treadmill time (exercise tolerance) for patients using the medicine when compared to placebo. These effects were noted after both the initial dose and following chronic administration.

Q: Is Imdur safe for people with kidney problems?

A: Regulatory sources include a caution for patients with renal (kidney) insufficiency, as they may be more susceptible to hypotensive effects. The official label describes that caution is needed and that a dose adjustment may be necessary.

Q: Is Imdur safe for people with liver problems?

A: Regulatory sources include a caution for patients with hepatic (liver) insufficiency, as they may be more susceptible to hypotensive effects. The official label describes that caution is needed and that a dose adjustment may be necessary.

Q: Can Imdur affect results on blood tests?

A: Official documents mention that blood tests may be needed to check for unwanted effects. Additionally, nitrates/nitrites may interfere with a specific chemical reaction used for determining serum cholesterol, which could potentially cause a falsely low reading.

How should Imdur sustained-release tablets be stored and disposed of?

Imdur sustained-release tablets must be stored and disposed of according to official regulatory requirements to maintain product stability and safety.

Storage Requirements

Condition Specification (Regulatory Labeling)
Temperature Store at controlled room temperature (typically 15 C to 30 C or below 30 C).
Protection Keep from freezing and protect from excess heat, moisture, and direct light.
Container Keep in the original container or blister pack and keep the container tightly closed.
Child Safety Store out of the reach and sight of children.

Disposal Instructions

Do not throw away unused or expired medicine via wastewater or household waste. The official procedure is to return the product to a pharmacist or designated collection program for proper pharmaceutical waste handling, following local regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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