Donox

Quick links to important sections

Medically reviewed

Marina Burgos

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 Donox

Property Description
Active ingredient Isosorbide Mononitrate (ISMN)
Form Tablets; Extended-Release Tablets
Pharmacological class Organic Nitrate; Vasodilator
General purpose Long-term maintenance of oxygen supply-demand balance in the heart
Origin Synthetic compound

What Type of Drug is Donox?

Donox is a prescription-only synthetic medication. Its active substance is Isosorbide Mononitrate (ISMN), and it is chemically recognized by the formula C6H9NO6. The medicine is classified as an Organic Nitrate Vasodilator, belonging to the anti-anginal class. This classification means the drug is clinically recognized for its ability to relax blood vessels, thereby reducing vascular resistance.


Composition and General Purpose

Donox is a single-ingredient product composed solely of Isosorbide Mononitrate, delivered via Oral dosage forms, typically as compressed Tablets or Extended-Release Tablets. The medication’s primary therapeutic purpose is to reduce the pressure and volume of blood returning to the heart, a mechanism known as reducing cardiac preload. This action helps lessen the effort required by the heart to function, a principle underlying its use as a continuous, prophylactic treatment. The Extended-Release formulation is a key differentiating factor, making Donox specifically suitable for a consistent, long-acting therapeutic profile.


Isosorbide Mononitrate vs. Other Nitrates

Isosorbide Mononitrate is distinct from similar nitrates because it is the pre-activated compound, meaning it does not require metabolic conversion in the liver before it can take effect. This feature ensures a high and predictable bioavailability when taken orally. Unlike preparations intended for rapid, acute intervention, Donox is formulated for a sustained, consistent presence in the body, which is essential for its role in the long-term maintenance of cardiac oxygen balance.

Regulatory References

  1. National Library of Medicine: DailyMed

What side effects are possible with Donox?

Possible Side Effects and Safety Information

The safety profile of Donox (Isosorbide Mononitrate) is based on its primary function as an organic nitrate vasodilator, and adverse reactions are officially classified by frequency, reflecting observations in clinical studies as documented by government health authorities.


Officially Documented Adverse Reactions

The most commonly reported side effects are directly related to the drug's effect on blood vessels.

Frequency Classification Examples System-Organ Class
Very Common Headache Nervous System
Common Dizziness, Hypotension, Nausea, Tachycardia Nervous/Vascular/Gastrointestinal
Uncommon Vomiting, Diarrhea, Flushing Gastrointestinal/Vascular
Rare Fainting (Syncope) Nervous System

Headache is the most frequent adverse reaction, generally occurring at the start of treatment and often diminishing or resolving within the first few weeks of continuous therapy. Hypotension (low blood pressure) is also a common and expected vascular effect.


Serious Safety Constraints

Official labeling defines specific restrictions based on potential severe risks:

  • Contraindicated Interactions: The use of Donox is strictly forbidden with Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil) due to the risk of precipitating profound, life-threatening hypotension and circulatory collapse.
  • Acute Conditions: The medication should not be used in patients experiencing circulatory shock, severe hypotension, or marked anemia.
  • Tolerance: Continuous, uninterrupted use may lead to a loss of therapeutic effect, a phenomenon known as tolerance. The official safety profile is structured around maintaining a regimen that accounts for this factor.

Overdose and Emergency Response

Overdose with Isosorbide Mononitrate is characterized by manifestations related to excessive vasodilation, as documented in regulatory labeling. The documented clinical signs include profound hypotension, a severe and persistent throbbing headache, tachycardia (fast heart rate) or paradoxical bradycardia, dizziness, confusion, and vomiting. These effects represent compromised function across the cardiovascular and central nervous systems.

Severe Outcomes and Emergency Action

Symptoms can escalate to life-threatening conditions such as syncope (fainting), circulatory failure, seizures, and coma. A rare, severe outcome is Methaemoglobinaemia, a blood disorder that may present with cyanosis. When overdose symptoms are suspected, immediate medical attention must be sought. If the affected individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened, official guidance mandates calling emergency services immediately.

Management is symptomatic and supportive. Treatment for hypotension involves measures such as intravenous fluid expansion to increase central fluid volume. Patients must undergo hospital monitoring for a minimum of 12 hours. The label also documents the specific treatment for Methaemoglobinaemia as the administration of Methylene Blue. The use of adrenaline or other arterial vasoconstrictors is explicitly not recommended.

Therapeutic Uses of Donox

Therapeutic Indications

Donox is primarily indicated for the management of hypertension, a condition characterized by persistently elevated blood pressure levels. By addressing high blood pressure, the medication helps reduce the workload on the cardiovascular system.

In addition to hypertension, Donox is used in the treatment of chronic stable angina pectoris. This condition involves chest pain or discomfort that occurs when the heart muscle does not receive an adequate supply of oxygenated blood, typically during physical exertion or stress.

Mechanism of Action and Benefits

The active components in Donox work by relaxing the smooth muscles of the blood vessels. This vasodilation leads to several physiological benefits:

  • Blood Pressure Regulation: By widening the systemic arteries, the medication lowers peripheral resistance, allowing blood to flow more easily and reducing overall blood pressure.
  • Improved Oxygen Delivery: In cases of angina, the relaxation of coronary arteries enhances the flow of oxygen to the myocardium, which helps prevent the onset of chest pain.
  • Reduced Cardiac Workload: By lowering the pressure against which the heart must pump, the medication helps decrease the heart's oxygen demand, supporting long-term cardiovascular stability.

Long-term Management

Donox is intended for the long-term control of chronic cardiovascular conditions rather than the immediate relief of acute symptoms. Consistent use as part of a comprehensive management plan helps maintain stable blood pressure levels and reduces the frequency of anginal episodes, contributing to the preservation of cardiovascular health over time.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Donox — Official Regulatory Information

Populations that Must Not Use the Medicine (Contraindications)

Classification Population/Condition
Contraindicated Patients with a history of severe hypersensitivity reactions, including anaphylaxis, to the medicine or any of its components.

Populations with Restricted Use

Population/Condition Eligibility Status (Regulatory Term)
Prior Anthracycline Use Use is restricted and must account for the patient's cumulative lifetime dose of all anthracyclines/anthracenediones due to the risk of cardiotoxicity.
Cardiac Impairment Requires mandatory assessment of cardiac function (e.g., LVEF) prior to and during therapy, with use limited in patients with pre-existing cardiovascular disease.
Hepatic Impairment Not Recommended for use in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C).

Specific Population Status

Population Group Regulatory Statement on Eligibility
Pregnancy Not Recommended; the medicine may cause fetal harm. Effective contraception is advised during and for a period after treatment.
Lactation Not Recommended; discontinue nursing during treatment.
Pediatric Use Safety and effectiveness have not been established.

Connection to the Overall Eligibility Profile

Regulatory documents structure eligibility by establishing an absolute exclusion for individuals with a known severe hypersensitivity history. Use is further constrained by the need to manage cardiotoxicity risk, requiring limits on cumulative exposure and pre-treatment cardiac assessment. The drug's safety profile also mandates use restrictions or recommends against use for individuals with specific physiological states, such as pregnancy, lactation, or moderate/severe hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Donox (Isosorbide Mononitrate) is primarily defined by the risk of potentiation of its vasodilatory effects, which can lead to severe hypotension (low blood pressure).


Official Regulatory Restrictions

Interaction Type Interacting Agents Official Regulatory Outcome
Absolute Contraindication Phosphodiesterase Type 5 (PDE-5) Inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil) Risk of severe, life-threatening hypotension and syncope. Co-administration is prohibited.
Absolute Contraindication Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat) Risk of severe, reinforced hypotension. Co-administration is prohibited.
Pharmacodynamic Risk Other Vasodilators (e.g., Beta-blockers, Calcium Channel Blockers), Neuroleptics, Tricyclic Antidepressants Potential for additive hypotensive effects.
Substance Interaction Alcohol (Ethanol) May potentiate the hypotensive effect, increasing the risk of light-headedness and postural hypotension.

Exposure-Modifying Interaction

Regulatory documents also note that co-administration of Isosorbide Mononitrate may potentially increase the blood level and hypertensive effect of agents such as Dihydroergotamine. The core interaction structure is highly constrained by the absolute prohibition against co-administering any agent that dramatically reinforces the nitric oxide pathway due to the critical risk of severe hypotension.

Mechanism of Action

How Donox Works

Donox, or Isosorbide Mononitrate, functions as a precursor that requires biotransformation within vascular smooth muscle cells. This process releases the active signaling molecule, Nitric Oxide (NO), which subsequently acts as an agonist for the enzyme Soluble Guanylate Cyclase (sGC). This critical interaction initiates the intracellular cascade that changes vascular smooth muscle tone.

The activation of sGC causes a concentration increase of the secondary messenger cyclic Guanosine Monophosphate (cGMP). Elevated cGMP levels suppress the activity of contractile proteins, such as Myosin Light Chain Kinase (MLCK), thus contributing to smooth muscle relaxation.

This relaxation is most pronounced in the veins, a process termed venodilation. This physiological change decreases the volume and pressure of blood returning to the heart (cardiac preload). The reduction in preload is the key physiological adjustment that decreases the mechanical work of the heart muscle and defines the drug’s systemic action. Sustained exposure can lead to tachyphylaxis due to the depletion of the necessary cellular sulfhydryl groups.

Dosage and Administration Information

How to Use Donox

Donox, which contains Isosorbide Mononitrate, is a prescription-only medication intended exclusively for long-term prophylactic maintenance. Its use is strictly defined to ensure consistent efficacy over time. The only approved route of administration is oral.


Dosing and Schedule Requirements

The administration schedule is asymmetric for Immediate-Release (IR) tablets and once-daily for Extended-Release (ER) tablets. This structure is mandated to incorporate a daily nitrate-free interval (or low-nitrate period) of approximately 14 hours, which is critical for minimizing the development of pharmacological tolerance.

Formulation Dosing Frequency Standard Maintenance Range
Immediate-Release (IR) Twice daily, asymmetrically (e.g., 7 hours apart) Up to 20 mg twice daily
Extended-Release (ER) Once daily, typically taken in the morning Up to 120 mg once daily

Administration Specifics

Physical Handling: Extended-Release tablets must be swallowed whole with fluid and must not be crushed, chewed, or split to preserve the controlled-release mechanism. Immediate-release tablets are generally taken with or without food, though some guidelines suggest administration on an empty stomach. This medication is not intended for the rapid treatment of acute episodes due to its slow onset of action.

Discontinuation: Treatment should not be stopped abruptly. The dosage must be gradually reduced over a period of time upon discontinuation, as instructed in official prescribing information.

Special Populations: While no routine adjustments are typically required for older adults, dosing often starts at the low end of the range. The safety and efficacy of Donox have not been established for use in pediatric patients.

Recent Clinical Evidence

Research Evidence / Overview of studies for Donox


Evidence for use in Chronic Stable Angina Pectoris

The research base for Donox (Isosorbide Monitrate) primarily consists of Randomized Controlled Trials (RCTs). These are studies where people are randomly assigned to receive either the medicine or a comparison treatment (like a placebo) to carefully track the results under specific conditions. These studies are applied in research exploring how symptoms change over time in individuals with chronic stable angina pectoris, a condition marked by functional limitations and episodic manifestations.

Studies explored outcomes related to the frequency of anginal attacks over defined time intervals. They also examined outcomes related to functional capacity using standardized exercise testing to measure the time until the onset of discomfort or the total duration of exercise. Findings describe patterns observed in these studies, including reports of changes in the frequency of anginal episodes and measurements of differences in the time to symptom onset during controlled exercise tests.

However, the evidence highlights a particular characteristic of this class of medication known as tolerance. Studies described that in the research contexts exploring tolerance development, the medication was often administered to include a daily "nitrate-free interval." Research describes this period as being associated with maintaining the patterns of measured outcomes observed in the studies.


Long-Term Studies and Durability of Effect

While research has clearly explored the short- to intermediate-term relief of symptoms, long-term effects are not fully established regarding the use of Donox. The available evidence for extended use tends to focus on the durability of symptom prevention and the consistency of the response over several months, rather than multi-year outcomes. This focus on exploring tolerance over time means research is ongoing into how to explore the consistency of the measured outcomes over defined time intervals.


What is Still Uncertain About Donox

The existing evidence base contributes to the broader evidence landscape but also highlights key areas where more research is needed. A major limitation is the lack of long-term, randomized controlled data concerning the medicine's impact on hard outcomes, such as the rate of heart attacks, need for cardiac procedures, or overall patient survival. Research does not determine whether an individual will respond similarly to the group patterns observed in trials. The findings describe group patterns, not personal outcomes, and the consistency of evidence varies across studies based on their size and duration.

Frequently Asked Questions (FAQ)

Common questions about Donox (FAQ)

Q: How quickly can I expect to notice any effects from Donox?

This medicine is used for long-term maintenance rather than for the rapid treatment of acute episodes. For Immediate-Release forms, the drug reaches its maximum concentration in the bloodstream within 30 to 60 minutes. However, the full, continuous prophylactic effect the medication is intended for is established over time.


Q: What is the typical length of time Donox stays in my system?

According to official pharmacokinetic studies, the active ingredient in Donox is eliminated from the plasma with an average half-life of about 5.1 hours. The half-life describes the time required for half of the drug to be removed from the bloodstream.


Q: Is it okay to drive or operate machinery while taking Donox?

Official information indicates that common side effects such as dizziness, light-headedness, or drowsiness can occur. Regulatory warnings suggest caution should be exercised when operating machinery or driving due to the potential for these effects.


Q: What are the most common reasons people stop taking Donox?

Studies have examined the reasons why some patients discontinue this medicine. The most commonly reported reasons for stopping include adverse reactions like headache, dizziness, and nausea or vomiting. The headache is generally the most frequently observed side effect during treatment initiation.


Q: Is Donox known to cause any long-term side effects?

Official documents describe that in industrial workers with high, long-term exposure to similar nitrates, true physical dependence has been noted. However, the regulatory relevance of this finding to the standard, routine clinical use of the medicine is not established.


Q: Is there a risk of withdrawal symptoms if I stop taking Donox suddenly?

Official prescribing information describes that treatment is not recommended to be stopped suddenly. Regulatory guidelines indicate that both the dosage and frequency should be reduced gradually upon discontinuation, as abrupt cessation may lead to a potential worsening or exacerbation of symptoms.


Q: Does Donox cause weight gain or weight loss?

Changes in body weight have been reported as adverse reactions. Official documents indicate that both weight gain and weight loss have been observed in some individuals.


Q: Can Donox affect my mood or energy levels?

Side effects related to the nervous system and mood have been reported. These adverse reactions can include feelings of nervousness, agitation, anxiety, confusion, and somnolence (drowsiness).


Q: Will taking Donox make me feel tired or drowsy?

Drowsiness (somnolence) has been reported as an adverse reaction in official safety documents. Other general feelings like fatigue or malaise (a general feeling of discomfort or uneasiness) have also been noted.


Q: Can Donox cause problems with sleep, like insomnia or vivid dreams?

Adverse reactions related to sleep have been reported in official product information. These reports include trouble sleeping, referred to as insomnia. In some cases, terrifying dreams or nightmares have also been reported.


Q: What should I do if I miss a scheduled time to take Donox?

Regulatory information describes that if a scheduled dose is missed, it should generally be skipped entirely. The official guidance indicates the next dose should be taken at the regular time to avoid an accidental double dose.


Q: Does Donox interact with common over-the-counter pain relievers?

Official guidelines indicate that paracetamol is generally safe to take with this medicine. However, non-steroidal anti-inflammatory drugs (NSAIDs) are advised against for regular use, as evidence indicates they may potentially worsen the underlying condition.


Q: Are there any specific vitamins or supplements that interact with Donox?

Official government guidelines state that there is not enough data or information to confirm the safety of taking complementary medicines, vitamins, or supplements with this medicine.


Q: Can Donox cause issues with sexual health or function?

Side effects related to sexual function have been reported in official safety documents. These side effects can include impotence and a reported loss in sexual ability or desire.


Q: Will Donox interact with herbal remedies, such as St. John's wort?

Official guidelines state that there is not enough information to confirm the safety of taking herbal remedies with this medicine.


Q: Can I take Donox if I have heart problems or high blood pressure?

The medicine can cause severe hypotension (low blood pressure) even at low doses. Official documents note that use is constrained by the need for caution in patients who are already hypotensive or who may be volume depleted.


Q: Is Donox safe for people with kidney disease?

Official pharmacokinetic studies indicate that the way the active ingredient is processed is not significantly altered by renal impairment. However, official guidance suggests that dose reduction may be considered for patients with marked renal insufficiency, and cautious dose titration is documented in the management of advanced chronic kidney disease (CKD).


Q: Is Donox associated with any changes in appetite?

Both increased appetite and loss of appetite have been reported in official adverse reaction documents.


Q: Is Donox considered a high-risk medication?

Regulatory labeling defines specific restrictions based on the potential for severe, life-threatening risks. These constraints include the absolute prohibition against use with certain other medications, due to the risk of profound hypotension and circulatory collapse.


Q: If I am taking Donox, how often should I be monitored by a healthcare provider?

Official information describes the need for monitoring of blood pressure, especially when the treatment is started or the dose is adjusted. The effectiveness of the treatment is typically assessed by a healthcare provider after approximately 2 to 4 weeks.


Q: Is it normal to feel a change in taste after starting Donox?

A change in taste has been reported as an adverse reaction in official safety documents. The reports specifically indicate that a bitter taste may occur.


Q: Does Donox interact with anesthesia if I need surgery?

According to official prescribing information, the medicine can increase the risk of severe hypotension (low blood pressure) when used with inhalational or intravenous anesthetics. Due to this risk, the prescribing information notes that healthcare professionals may consider discontinuing the medicine prior to surgery.


Q: What is the regulatory status of Donox in major countries like the US and UK?

This medicine is a prescription-only product that has been approved by major regulatory bodies globally, including the U.S. Food and Drug Administration (FDA). The official Summary of Product Characteristics (SmPC) containing product information is documented by these agencies.


Q: Who determined the initial approved uses for Donox?

The official approved uses and indications for this medicine were determined and authorized by national regulatory drug agencies. This includes the U.S. Food and Drug Administration (FDA) and other agencies that publish the official product labeling and documentation.

How should Donox be stored and disposed of?

How to Store and Dispose of Donox (Isosorbide Mononitrate)

Donox must be stored strictly according to regulatory guidelines to ensure product stability and safety.

Storage Requirement Specification
Temperature Controlled Room Temperature: 20 C to 25 C (68 F to 77 F), with excursions permitted to 30 C.
Protection Keep the medication in its original container and ensure the container is tightly closed.
Environmental Constraints Protect the tablets from excessive moisture and heat. Do not freeze or refrigerate the product.
Child Safety Store Donox out of the sight and reach of children.

For disposal, unused or expired Donox should be handled safely. Official guidelines recommend using a medicine take-back program. If a program is unavailable, the product should be disposed of in household trash by mixing it with an undesirable substance and sealing it in a container. Do not flush Donox down the toilet or pour it down a drain.

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

Available in countries:

Equivalent of Donox found in:

A-Z Index: