Isosorbidedinitraat CF

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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 Isosorbidedinitraat CF

What is Isosorbidedinitraat CF?

Isosorbidedinitraat CF is a medication that belongs to a group of drugs known as vasodilators, specifically organic nitrates. These substances work by relaxing the smooth muscles in the walls of the blood vessels. This relaxation causes the blood vessels to widen, a process called vasodilation.

How it works

When the blood vessels expand, it becomes easier for the heart to pump blood through the body. This process reduces the workload on the heart muscle and decreases the heart's demand for oxygen. By improving blood flow and reducing cardiac strain, the medication helps manage conditions related to restricted blood supply to the heart.

Purpose of the medication

Isosorbidedinitraat CF is primarily used for the management of chest pain, commonly referred to as angina pectoris. Angina occurs when the heart muscle does not receive enough oxygen-rich blood, often during physical exertion or stress.

There are two main applications for this medication:

  • Acute Relief: Some forms of the medication are designed to act quickly to stop an ongoing angina attack.
  • Prevention: Other forms are used as a long-term maintenance treatment to reduce the frequency and severity of angina attacks over time.

In certain cases, it may also be used as a supplementary treatment for chronic heart failure, where it helps the heart function more efficiently by reducing the pressure it must pump against.

Regulatory References

  1. WHO Essential Medicines List

What side effects are possible with Isosorbidedinitraat CF?

Possible Side Effects and Safety Information

Isosorbidedinitraat CF's safety profile is largely defined by its blood vessel-widening action, which dictates both its most common side effects and most serious restrictions.

Frequency-Classified Adverse Reactions

Classification Adverse Reaction
Very Common (≥ 1 in 10 users) Headache (often lessens with continued use)
Common (≥ 1 in 100 users) Dizziness, low blood pressure (hypotension), nausea, vomiting
Uncommon (≥ 1 in 1,000 users) Flushing, allergic skin reactions, severe circulatory collapse, syncope (fainting)
Very Rare (< 1 in 10,000 users) Heartburn

Serious Adverse Reactions and Safety Restrictions

Serious Reactions documented in regulatory sources include severe hypotension leading to circulatory collapse and shock, severe allergic reactions, and paradoxical increased chest pain (angina pectoris) in the setting of low blood pressure. Use may also be associated with methemoglobinemia, a condition where oxygen delivery in the blood is impaired, which is rare but significant.

Absolute Contraindications prohibit the use of this medicine alongside phosphodiesterase type 5 (PDE5) inhibitors (like sildenafil or tadalafil) or the soluble guanylate cyclase (sGC) stimulator riociguat. Combining these drugs poses a high risk of life-threatening severe hypotension.

Caution is required when prescribing this medicine to patients with conditions such as severe low blood pressure, low blood volume (hypovolaemia), severe anemia, certain heart conditions (like hypertrophic obstructive cardiomyopathy), or diseases associated with raised pressure inside the skull.

Exposure-Related Patterns include the potential for tolerance (loss of effect) with prolonged, continuous use, and the risk of physical dependence and rebound effects if treatment is suddenly stopped. The most common side effect, headache, is often transient and can be a marker of the drug's activity, frequently diminishing after the first weeks of therapy.

Overdose and Emergency Response

The official overdose profile for Isosorbide Dinitrate, documented in government regulatory sources, establishes the necessity to seek emergency medical attention immediately if an over-exposure is suspected. The profile is defined by the consequences of severe systemic vasodilation.

Documented Overdose Manifestations

Overdose manifestations include a prompt and excessive fall in blood pressure (hypotension), often accompanied by syncope (fainting), vertigo, and palpitations. Central disturbances are listed as a severe throbbing headache, visual disturbances, and altered consciousness, potentially leading to convulsions or coma in severe cases. Gastrointestinal effects may include nausea, vomiting, and bloody diarrhea.

Severe Outcomes and Required Actions

The primary severe outcome is a hypotensive response that can result in circulatory collapse. Regulatory documents cite methemoglobinemia as a serious complication associated with moderate organic nitrate overdoses. Since no specific antagonist is known, treatment is based on supportive care. Described management measures include elevation of the extremities and central volume expansion to address severe hypotension. Careful clinical or hemodynamic monitoring is officially required during the management period. The potential for death is noted in severe overdose scenarios.

Therapeutic Uses of Isosorbidedinitraat CF

What Isosorbide Dinitrate CF Treats: Main Uses and Benefits

Isosorbide dinitrate is a medication generally applied across domains where additional symptomatic support is needed, assisting in contexts involving heightened systemic burden. The medicine is commonly used to help with symptoms related to heightened physiological activity and contributes to easing the overall strain linked to organ-specific functional stress.

This medication is primarily relevant for managing conditions characterized by periods of heightened symptoms, namely: angina (chest pain) and heart failure.

It is commonly used for the prophylaxis (prevention) of angina symptoms, which involve symptoms related to physical discomfort. Its use helps address symptom clusters that may become intense or disruptive, contributing to improved comfort during symptomatic periods. This application is used when symptoms intensify and supportive relief is needed, specifically for managing angina (chest pain) linked to coronary artery disease.

The medicine is also commonly used with other medications as supportive relief in the treatment of heart failure, a condition characterized by periods of heightened symptoms. This supportive use assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations associated with the condition.

Quick Fact: Relief for Symptoms related to physical discomfort

Regulatory References

  1. NIH MedlinePlus Drug Information on Isosorbide

Eligibility and Restrictions for Use

Who can and cannot use Isosorbidedinitraat CF?

Eligibility for Isosorbidedinitraat CF is strictly defined by regulatory authorities and is determined by specific medical conditions and concurrent medication use.

Absolute Contraindications

The medicine is contraindicated and must not be used by patients who have a known hypersensitivity to isosorbide dinitrate or any other organic nitrate derivative. Use is also strictly prohibited in patients who are concurrently taking Phosphodiesterase Type 5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil) or the Soluble Guanylate Cyclase (sGC) stimulator Riociguat.

Furthermore, Isosorbide Dinitrate is contraindicated in states of severe hypotension (low blood pressure), Cardiogenic Shock, and specific heart conditions such as Hypertrophic Obstructive Cardiomyopathy.

Restricted and Conditional Use

Population Group Regulatory Status
Pediatric Population Safety and efficacy have not been established. Use is generally not recommended.
Pregnant/Lactating Women Use is permitted only if the potential benefit justifies the potential risk to the fetus or infant.
Severe Hepatic/Renal Impairment Use with caution is required due to potential alteration in the drug's clearance.
Older Adults (Geriatric) Use is permitted, but caution is advised in dose selection reflecting the potential for decreased organ function.

Eligibility rules for this medicine are designed to prevent specific high-risk scenarios and require a thorough review of cardiovascular stability, organ function, and current medication regimen.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Classification Interacting Agents and Regulatory Restriction
Formal Contraindication Co-administration with Phosphodiesterase type 5 (PDE5) Inhibitors (including Sildenafil, Tadalafil, Vardenafil, and Avanafil) is strictly prohibited. The use of the soluble guanylate cyclase stimulator Riociguat is also contraindicated. This restriction is based on the risk of severe, life-threatening hypotension.
Mandatory Separation A specific time separation is required after the last dose of certain contraindicated agents before Isosorbidedinitraat CF can be administered: 24 hours after Sildenafil and 48 hours after Tadalafil.
Pharmacodynamic Effects Alcohol exhibits additive vasodilating effects, which may enhance the reduction in blood pressure. Additive hypotensive effects are also documented with other Antihypertensive Agents and vasodilators. Co-administration with certain local anesthetics may increase the risk of methemoglobinemia.
Pharmacokinetic Effects Interactions involving the major metabolic enzyme CYP3A4 are documented. The drug’s systemic exposure may be formally increased by CYP3A4 inhibitors (e.g., Fexinidazole) or decreased by CYP3A4 inducers (e.g., Carbamazepine), potentially modifying the clinical effect.
Population Caution The risk of severe hypotension is heightened in specific populations, including subjects with blood volume depletion or a baseline systolic blood pressure below 90 mm Hg. Additionally, nitrate therapy may aggravate the angina associated with Hypertrophic Cardiomyopathy.

Mechanism of Action

How Isosorbidedinitraat CF Works

Isosorbidedinitraat CF functions as a prodrug that undergoes enzymatic bioactivation within the vascular smooth muscle cells to release Nitric Oxide (NO). This NO acts as an activator of the intracellular enzyme soluble Guanylyl Cyclase (sGC), which catalyzes the synthesis of the second messenger, cyclic Guanosine Monophosphate (cGMP). The subsequent increase in cGMP initiates a molecular cascade that leads to the dephosphorylation of Myosin Light Chains and a reduction in intracellular calcium ions, resulting in the relaxation of the smooth muscle fibers (vasodilation).

This vasodilation preferentially affects the large venous capacitance vessels, significantly reducing venous return to the heart and decreasing the volume and pressure inside the chambers (reduced Preload). Additionally, the dilation of coronary arteries enhances blood flow to the heart muscle. A slight reduction in arterial resistance lowers Afterload. This combined hemodynamic effect contributes to a reduction in myocardial workload and oxygen consumption.

Dosage and Administration Information

How to Use Isosorbidedinitraat CF

Isosorbidedinitraat CF is administered using distinct patterns based on the required speed of onset and duration of effect, with the administration governed by the need to prevent the development of drug tolerance (tachyphylaxis). The medication is available for administration via oral and sublingual routes for outpatient use, with an intravenous (IV) route also available in supervised clinical settings.

Administration Schedule and Dosing

For chronic use, an intermittent dosing schedule is required. This involves a daily nitrate-free interval, often lasting at least 14 hours, to maintain the medicine's continued effectiveness. Doses are spaced to fit within the remaining period, typically involving administration multiple times during the waking hours.

Dosage Form Typical Maintenance Dose Administration Specifics
Immediate-Release Tablet 5 mg to 40 mg, two to four times daily Preferably taken on an empty stomach.
Sustained-Release Form 40 mg, once or twice daily Must be swallowed whole; do not crush, split, or chew.
Sublingual Tablet 2.5 mg to 10 mg, as needed Placed under the tongue and allowed to dissolve; do not swallow.

Procedural and Population Rules

For older adults, dosing is typically cautious, starting at the lower end of the dose range. In the event of a missed dose, the standard approach is to skip the missed dose if it is almost time for the next scheduled dose; double doses should not be taken. These protocols define the standardized application of the medicine.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Isosorbide Dinitrate CF


Evidence from Research Trials for Heart Failure

The research supporting the evaluation of Isosorbide Dinitrate in research contexts exploring heart failure is primarily based on Randomized Controlled Trials (RCTs) and observational data. These studies examined the compound's use, particularly when evaluated in combination with other agents, for conditions characterized by systemic or functional imbalance. Researchers focused on key measured events such as all-cause mortality and the frequency of hospitalization due to heart failure. They also measured changes in daily functioning or activity level, for instance, by assessing a patient's exercise capacity.

The evidence supporting the evaluation of the compound in combination with other drugs is categorized as having high study design rigor for specific defined populations. However, the available data are still emerging or were mixed when the compound was studied as the sole intervention or in patients with preserved functional capacity.


Evidence from Research Trials for Angina (Chest Pain)

For research exploring angina (chest pain), the research relies heavily on short-term Randomized Controlled Trials and regulatory-reviewed studies. These trials were applied in studies examining patient-reported experiences related to acute or episodic chest pain. Studies examined patients with stable angina, focusing on outcomes related to physical discomfort and how frequently painful episodes occurred.

The research base describing the short-term physiological action of the fast-acting forms is available across multiple studies. However, the findings indicate that for use over longer periods, the follow-up durations were limited. The research describes a pattern where the measured action seen after an initial dose may not be fully sustained with continuous administration, due to the finding of diminished measured action over time (known as tolerance).


Understanding Long-Term Studies and Follow-up

For both areas of research, there is limited information for long-term outcomes that fully establish the sustained impact and durability of the measured action over several years. This means that while research provides context into short-term changes, the physiological action's profile in long-term, maintenance scenarios are not fully established.

How should Isosorbidedinitraat CF be stored and disposed of?

How to Store and Dispose of Isosorbidedinitraat CF

Official regulatory documents require specific storage and handling conditions for Isosorbidedinitraat CF (Isosorbide Dinitrate) to maintain its stability.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, typically 20^circC to 25^circC (68^circF to 77^circF).
Protection Keep the medicine away from excess heat and moisture and ensure protection from light.
Container Rule Must be kept in the original container and the container must be tightly closed.
Safety Rule Mandatorily keep this medication out of the sight and reach of children.

Disposal Instructions

Expired or unused Isosorbidedinitraat CF tablets must not be disposed of via household waste or wastewater. The recommended procedure is to utilize drug take-back programs or consult a pharmacist for official disposal guidance to ensure environmental protection. Outdated medication should be discarded after its expiration date.

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

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