Sigmart

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Sigmart

Method of action: Antianginal, Cardiac Therapy

Treatment option: Seizure Prophylaxis

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 Sigmart

Quick Facts

Property Description
Active ingredient Nicorandil
Form Oral Tablets (Primary), Intravenous Solution
Pharmacological class Antianginal Agent, Vasodilator
General Purpose Reduces heart workload and increases blood supply
Origin Synthetic, K^+ATP Channel Activator/Nitrate Derivative

What is Sigmart and What Type of Drug is it?

Sigmart is the trade name for a pharmaceutical product containing the active ingredient Nicorandil, which is formally classified as an Antianginal Agent and a Vasodilator. Its primary purpose is to help relieve chest discomfort by improving the supply of oxygenated blood to the heart muscle. Sigmart is a prescription-only (Rx) medication and a monotherapy, meaning it contains only the single active substance, Nicorandil. The medicine is typically available in the oral form as tablets, though a sterile solution for intravenous use exists for specific clinical settings.


Nicorandil: Composition and Unique Chemical Nature

The Nicorandil compound is a synthetic organic molecule that is chemically recognized as a derivative of nicotinamide. Its structure is unique in that it features two distinct functional groups: a nitrate moiety and a component that allows it to act as an ATP-sensitive potassium channel (K^+ATP) opener. This chemical duality provides the basis for its dual mechanism of action. The final oral product composition consists of Nicorandil combined with standard, inactive pharmaceutical excipients necessary for tablet formation.


What is the General Purpose of This Dual-Action Medicine?

The general purpose of Sigmart is to establish a balanced reduction of cardiac workload through comprehensive vasodilation, meaning it simultaneously relaxes and widens blood vessels throughout the body. The mechanism involves two complementary actions: the nitrate-like effect primarily causes the widening of veins (reducing preload), while the potassium channel activation causes the widening of arteries and coronary resistance vessels (reducing afterload). This dual action helps optimize the heart’s function by lowering its energy requirement and ensuring a more efficient delivery of blood to the muscle, which is the core therapeutic goal in managing episodes related to insufficient blood flow.

What side effects are possible with Sigmart?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse effects and safety characteristics of Nicorandil (Sigmart), based strictly on government regulatory classifications and prescribing information.


Adverse Reaction Scope and Classification

Adverse reactions are classified by frequency and system-organ class according to standard regulatory definitions.

Classification Examples of Reactions
Very Common Headache
Common Dizziness, Nausea, Vomiting, Flushing, Hypotension
Uncommon Oral Ulceration, Anal Fissure
Rare Gastrointestinal Ulceration, Angioedema, Exfoliative Dermatitis

Gastrointestinal Disorders and Nervous System Disorders are among the main systems affected, with Headache being the most frequently reported effect. This effect and hypotension (low blood pressure) are documented to be more common at the start of treatment or during dose escalation, often diminishing with continued use.


Serious Safety Considerations

Regulatory documents highlight several Rare but clinically significant adverse reactions. These include deep and refractory gastrointestinal ulcerations which carry a risk of perforation, haemorrhage, or fistula formation. Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, are also listed as rare adverse events.


Population-Specific Notes and Restrictions

Specific safety considerations exist for certain groups. Older Adults (aged 65 years and over) are noted to have an increased risk of gastrointestinal ulcerations. The medicine is contraindicated in patients with pre-existing conditions like cardiogenic shock, severe hypotension (systolic blood pressure below 90 mmHg), and left ventricular failure with low filling pressure. Co-administration with phosphodiesterase type 5 inhibitors (PDE5is) is also strictly prohibited due to the risk of severe hypotension, a high-level safety consequence documented in official labeling.

Overdose and Emergency Response

A Sigmart (Nicorandil) overdose is formally documented as an extreme manifestation of its primary action, leading to a state of excessive and sustained peripheral vasodilation. The recognized clinical signs of an acute overdose in regulatory labeling include a profound fall in blood pressure (hypotension) and a compensatory reflex tachycardia (increased heart rate). Regulatory documents classify this as a potentially severe event that can escalate to a life-threatening situation if the resulting hypotension is not corrected.

Any suspected or confirmed overdosage requires that an individual seek immediate medical attention due to the risk of critical hypotension and the need for specialized management. No specific antidote is known for Nicorandil, meaning treatment protocols are strictly supportive and symptomatic, as defined in official regulatory documents.

Required supportive measures include continuous monitoring of cardiac function. The official procedural steps focus on counteracting the severe vasodilation, including the increase in circulating plasma volume by substitution of fluid (volume loading). In cases of severe or life-threatening hypotension, the administration of vasopressors must be considered as part of the mandated clinical response to stabilize circulation.

Therapeutic Uses of Sigmart

What Sigmart Treats: Main Uses and Benefits

Sigmart (Nicorandil) is a medication that plays a role in managing angina in patients with certain cardiovascular conditions. Its use is primarily centered around managing symptoms related to physical discomfort and supporting long-term stability. The medication is commonly used to help with symptomatic management for individuals experiencing stable angina pectoris and is relevant in conditions involving episodic or fluctuating manifestations, such as vasospastic angina (Prinzmetal’s angina). The therapeutic application of this medicine is directed toward managing the symptoms of these chronic conditions.


Managing Chronic Angina and Supportive Therapy

This medication is commonly used in adult patients diagnosed with chronic stable angina. It helps address symptom clusters that include recurring chest discomfort, pressure, or tightness, which often appear suddenly or intensify during phases of increased physiological stress. Applying this support may contribute to improved day-to-day comfort and a reduction in the frequency and severity of these disruptive symptom manifestations.

Sigmart is applied when additional symptomatic support is needed alongside existing anti-anginal therapies. The long-term use in patients with established Coronary Artery Disease (CAD) is relevant across domains involving the stabilization of symptoms for these patients. This supports patients during episodes of heightened discomfort and assists with maintaining functional stability.


Quick Fact: Relief for Episodic Chest Discomfort

Category Description
Primary Focus Conditions characterized by periods of heightened symptoms
Symptom Managed Symptoms of increased physiological stress
Benefit Type Reduction in symptom frequency and intensity

Eligibility and Restrictions for Use

Who Can and Cannot Use Sigmart?

Sigmart (Nicorandil) is officially restricted to adults (age 18 and over) who require symptomatic treatment for stable angina. Regulatory labeling establishes several absolute contraindications, primarily tied to acute haemodynamic status and concurrent medications.

Category Regulatory Status Population/Condition
Contraindicated Absolute Ban Patients with cardiogenic shock, severe hypotension, hypovolaemia, or acute pulmonary oedema.
Contraindicated Drug Interaction Concurrent use with Phosphodiesterase 5 (PDE-5) inhibitors (e.g., sildenafil) or soluble guanylate cyclase stimulators is prohibited.
Not Recommended Age Group Paediatric patients (under 18 years) are not recommended, as safety and efficacy have not been established.
Conditional Use Physiological State Pregnancy (use only if benefit outweighs risk) and lactation (not recommended, due to unknown excretion into human milk).

Additional official constraints advise special caution for patients with low systolic blood pressure, a history of diverticular disease, or G6PD deficiency. No special dosage requirements are officially noted for patients with documented liver disease or chronic renal impairment. These official rules strictly govern who can and cannot use the medicine according to government-approved product information.

What should I know about interactions with other medicines?

Sigmart Interactions with other medicines and products

Official regulatory information details specific medicinal products and product classes that interact with Sigmart (Nicorandil), primarily due to its vasodilatory action and potential for systemic risk.


Contraindicated Combinations

Classification Interacting Agents (Examples)
Prohibited Co-administration Phosphodiesterase 5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil, vardenafil); Soluble Guanylate Cyclase (sGC) Stimulators (e.g., riociguat).

Co-administration with these agents is contraindicated because the synergistic effect can lead to a serious and potentially life-threatening drop in blood pressure (severe hypotension).


Other Documented Interactions

  • Blood Pressure Lowering Agents: Concomitant use with antihypertensive agents, other vasodilators, or tricyclic antidepressants may result in an increased hypotensive effect.
  • Gastrointestinal Risk: Caution is advised when used with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including high-dose acetylsalicylic acid, or corticosteroids, due to the reported increase in risk for severe gastrointestinal complications such as ulceration, perforation, and hemorrhage.
  • Potassium Levels: Caution is required with medicinal products that may increase potassium levels (e.g., ACE inhibitors or ARBs) due to the risk of severe hyperkalaemia. This risk is specifically noted for patients with moderate to severe renal impairment.
  • Pharmacokinetic Profile: The metabolism of Nicorandil is officially stated as not being significantly affected by the co-administration of the CYP inhibitor cimetidine or the CYP3A4 inducer rifampicin.
  • Alcohol: The blood pressure lowering effect of Nicorandil may be increased when consumed with alcohol.

Mechanism of Action

The mechanism of action for Sigmart (Nicorandil) is rooted in its unique structure, which allows it to modulate key physiological pathways, resulting in the modulation of ventricular Preload and Afterload.


Modulating Vascular Tone through Dual Molecular Pathways

Nicorandil functions as a vasodilator with dual mechanistic components by engaging two separate molecular mechanisms in vascular smooth muscle cells. The drug is a direct activator of ATP-sensitive potassium channels (K^ + ATP), which hyperpolarizes the cell membrane and causes the relaxation and widening of the arteries and coronary resistance vessels. Simultaneously, its nitrate moiety acts as a Nitric Oxide (NO) donor, initiating the NO/cGMP signaling pathway, which primarily relaxes the peripheral veins.


Achieving Balanced Hemodynamic Load Reduction

The complementary effect of these two mechanisms results in simultaneous modulation of cardiac loading. The arterial dilation (via K^ + ATP activation) reduces Afterload (the resistance the heart pumps against), while the venous dilation (via NO donation) reduces Preload (the volume of blood returning to the heart). This simultaneous and balanced unloading of the heart's chambers is the core physiological consequence of the drug's action, resulting in a decrease in the myocardial oxygen demand of the heart muscle.


Mechanistic Sustainability (Tolerance Profile)

The incorporation of the K^ + ATP channel opening mechanism provides a non-NO dependent pathway for vasodilation. Since the K^ + ATP component operates independently of the metabolic co-factors sometimes depleted in the NO/cGMP pathway, the overall vasodilatory function is less affected by pharmacological tolerance over continuous exposure. This characteristic supports the maintenance of vascular relaxation and hemodynamic balance.

Dosage and Administration Information

Sigmart (Nicorandil) is primarily administered via the oral route as a tablet for the long-term management of chronic stable angina, although a solution for intravenous use is authorized for specific acute clinical settings. The medicine is dosed and scheduled for intake twice daily (bid), typically taken once in the morning and once in the evening, to help maintain consistent levels of the active substance.

The standard administration begins with an initial dose of 10 mg twice daily. For patients particularly susceptible to headache, a lower starting dose of 5 mg twice daily may be used. The dosage is not fixed but must be titrated upwards according to individual need and tolerance, with the usual therapeutic range being between 10 mg and 20 mg twice daily. The maximum authorized dose that may be administered is 40 mg twice daily.

Procedurally, the tablets are designed to be swallowed whole using some liquid. Administration is independent of food intake, meaning the dose can be taken either with or without a meal. Due to their sensitivity to moisture, the tablets must be kept in their original blister packaging until the time of intake. Regarding specific populations, no special dosage adjustments are formally required for older adults or individuals with renal or hepatic impairment. Conversely, the use of Sigmart in the pediatric population is not recommended as its efficacy and safety in children have not been established.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sigmart

This overview describes the types of research that have been conducted on Sigmart (Nicorandil) to understand what research exists regarding its evaluation in certain heart conditions. It focuses on the patterns observed in the evidence base without making claims about specific outcomes for individual patients.


Evidence for use in Chronic Stable Angina Pectoris

Research exploring the evaluation of Nicorandil for chronic stable angina pectoris includes large-scale Randomized Controlled Trials (RCTs) alongside many smaller, shorter-term studies and observational studies. These trials typically included adult patients with established Coronary Artery Disease.

Researchers monitored two primary types of outcomes: measurements related to physical discomfort (such as angina episode frequency and exercise capacity) and, in longer studies, combined outcomes known as Major Cardiovascular Events (MACE).

Findings describe patterns where the incidence of the defined MACE composite endpoint was measured and recorded in comparison to placebo in the primary large long-term study. For measures of symptom relief, studies report how symptoms evolved in comparison to the specific anti-anginal medications used as comparators in those trials. The evidence landscape includes multiple studies for short-term symptom relief but relies heavily on a single major trial for the extended-duration prognostic outcomes.


Evidence for Acute Use During Coronary Procedures

The evidence for evaluating Nicorandil acutely, such as during angioplasty (PCI), is derived from numerous smaller and moderate-sized Randomized Controlled Trials (RCTs). The research examined measurements of heart status rather than final clinical events, focusing on tracking specific blood markers (cardiac enzymes) and measuring function in the small blood vessels (microvascular function).

Findings described patterns where the groups receiving Nicorandil were observed in some studies to have different measurements of these blood markers and blood flow indices. The evidence quality varies across studies, and information comparing Nicorandil to all currently used anti-anginal medications remains limited, as much of the initial comparative data is older.

Frequently Asked Questions (FAQ)

Common questions about Sigmart (FAQ)

Q: Is Sigmart a brand-name drug, and is a generic version available?

Sigmart is a medicine containing the active ingredient nicorandil. Regulatory information indicates that the drug is available under various brand names, such as Ikorel, but a generic version containing only nicorandil is also available. Availability often depends on your specific location.

Q: How long does it typically take for a person to notice the effects of Sigmart?

Nicorandil is a vasodilator, meaning it opens blood vessels. Its action may begin to provide relief within about an hour, but it may take several days (up to four or five days) of consistent use to achieve its full effect. This timeframe is based on the drug’s reported pharmacological profile.

Q: What is the main difference between Sigmart and other similar drugs in its class?

Official product information highlights that Nicorandil has a dual mechanism of action. It works similarly to a nitrate (a Nitric Oxide donor) by relaxing veins, and it also activates ATP-sensitive potassium channels (K^+ATP), which widens arteries. This combination is described as distinct among some medicines used for stable angina.

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

Regulatory information indicates that Sigmart is generally safe to take alongside paracetamol. Official information indicates that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or high-dose aspirin, when used with Sigmart, are associated with an increased risk of serious gastrointestinal ulcers.

Q: Can Sigmart cause changes in a person's weight (gain or loss)?

Side effects, in general, are mentioned in official safety documents. Although rare, a serious side effect called severe gastrointestinal ulceration may lead to associated symptoms, including weight loss.

Q: Are the side effects of Sigmart usually temporary or are they long-lasting?

Common side effects like headache and dizziness are often temporary and may improve as treatment continues. However, official safety updates indicate that certain serious adverse effects, such as ulcers, can be persistent and may take weeks or months to heal after stopping the medicine.

Q: What are the most common reasons a person may not be eligible to take Sigmart?

Official documents list contraindications (reasons to avoid use). These include known allergy to nicorandil, low blood pressure (hypotension), fluid build-up in the lungs (pulmonary oedema), and certain severe heart conditions, such as heart failure.

Q: Is it safe to consume alcohol while undergoing treatment with Sigmart?

Regulatory documents state that Nicorandil may potentially increase the effects of alcohol. It is important to note that this potential interaction exists when consuming alcohol while taking this medication.

Q: Does Sigmart carry a "Black Box Warning" from regulatory agencies?

The drug is not widely reported to carry the specific US Black Box Warning. However, global regulatory bodies have issued strong warnings and safety updates regarding the risk of serious gastrointestinal ulceration associated with its use.

Q: What are the high-level themes of research evidence supporting the use of Sigmart?

Studies and official information indicate that research has examined the drug’s effects on major cardiovascular events. Key themes include the reduction of CHD-related death, non-fatal myocardial infarction, and unplanned cardiac hospitalisation.

Q: Are there any known interactions between Sigmart and herbal supplements like St. John's Wort?

Official safety guidance generally notes that there is not enough data to confirm the safety of most herbal remedies alongside Sigmart. St. John's Wort is specifically mentioned as a product known to interact with many different medicines.

Q: Is Sigmart safe for women who are pregnant or planning to become pregnant?

Nicorandil is generally not recommended during pregnancy. This is because official documents state there is currently insufficient information to confirm its safety for both the mother and the developing baby.

Q: What should a patient look out for that indicates a serious adverse reaction to Sigmart?

Regulatory safety updates highlight that signs of ulceration, particularly in the mouth, stomach, or bowels, represent a serious adverse reaction. Symptoms of this serious reaction may include new pain, unusual bleeding, or persistent wounds.

Q: What is the difference between a "Warning" and a "Precaution" listed for Sigmart?

In regulatory terms, a Warning typically addresses a significant risk that requires serious consideration before or during treatment. A Precaution highlights situations where special caution is necessary, such as when a patient has certain pre-existing medical conditions.

Q: Is it normal to experience mild dizziness when first starting Sigmart? (Clarification)

Regulatory product information states that dizziness is a common side effect of Nicorandil, meaning it may occur in up to 1 in 10 people. It is most often experienced when a patient first begins treatment.

Q: How does the body eliminate (metabolize) Sigmart? (Pharmacokinetics)

Nicorandil is eliminated through a process called metabolism. Some research cited in official documents suggests that the breakdown process in the body may create a metabolite that is linked to the drug's rare, but serious, adverse effects like ulceration.

Q: What is the role of Sigmart in a comprehensive treatment plan for my condition? (General context)

Nicorandil is designated as a second-line treatment option for symptoms of angina. This means it is typically used when first-line medicines, such as beta-blockers or calcium antagonists, are not fully effective, are not tolerated, or are medically unsuitable.

Q: Does Sigmart have any known effects on a person's fertility or sexual function?

Regulatory documents state that information currently available does not indicate that Nicorandil reduces fertility in either men or women.

Q: Does the research show any long-term effects of taking Sigmart for many years?

Research studies have been conducted to assess the drug's long-term effects. These studies have involved large numbers of participants and have been designed to look at outcomes and safety over periods of at least one year.

Q: Is Sigmart considered safe for breastfeeding mothers?

Nicorandil is generally not recommended while breastfeeding. This is because it is unknown how much of the drug passes into breast milk or what potential effect it might have on the nursing baby.

Q: Why do people sometimes experience mild stomach upset when they first start Sigmart?

Official product information lists nausea and vomiting (stomach upset) as common side effects of Nicorandil, occurring in up to 1 in 10 people. These effects are often associated with the initial phase of starting treatment.

Q: Does Sigmart affect blood sugar levels, even if it's not primarily a diabetes drug?

Studies indicate that the drug's mechanism of action on potassium channels may, in some cases, cause a significant rise in postprandial blood glucose (blood sugar levels measured after a meal). This is based on research related to the drug's pharmacology.

Q: Are there any restrictions on driving or operating machinery while taking Sigmart?

Official guidance advises that restrictions are in place if the medicine causes specific side effects like dizziness or weakness. If these effects occur, official guidance suggests avoiding activities such as driving or operating tools and heavy machinery.

Q: How does Sigmart's mechanism of action differ from older treatments for the same condition?

The drug’s mechanism is unique because it has a dual action. It works as a nitrate (NO donor) and also activates ATP-sensitive potassium channels (K^+ATP). This combined effect is described as providing actions that are distinct from those provided by pure nitrates, a class of older treatments.

How should Sigmart be stored and disposed of?

How to Store and Dispose of Sigmart (Nicorandil) Tablets

The storage of Sigmart tablets must strictly follow official regulatory requirements to maintain product stability, as the medicine is highly sensitive to moisture.


Official Storage and Handling

Requirement Type Condition
Temperature Store below 25°C.
Protection Keep in the original package to protect from moisture.
Stability Each blister strip must be used within 30 days of opening the strip.
Safety Store out of the sight and reach of children.

Tablets must remain in their original blister until immediately before use. The desiccant capsule within the packaging must not be swallowed. Any unused or expired product must be disposed of in accordance with local pharmaceutical waste regulations.

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

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