Nitroglicerina Sicma

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Nitroglicerina Sicma

Nitroglicerina Sicma is a pharmaceutical product whose active ingredient is Nitroglycerin (also known as Glyceryl Trinitrate). It is a highly established medication used for the management and prevention of acute episodes of angina pectoris, which is a type of chest pain caused by reduced blood flow to the heart muscle.

This medication belongs to a group of drugs classified as nitrate vasodilators and is available only by prescription (Rx).

Property Description
Active Ingredient Nitroglycerin (Glyceryl Trinitrate)
Pharmacological Class Nitrate Vasodilator
Common Use Acute relief and prevention of Angina (Chest Pain)
Typical Form Sublingual Tablet/Spray (Rapid Action)
Rx Status Prescription Only

The specific Sicma designation refers to the brand or preparation of the drug, which is typically supplied in a rapid-acting sublingual form (tablet or spray). This particular formulation is intended to allow the drug to be absorbed quickly under the tongue, providing prompt relief when an anginal attack occurs.

Nitroglycerin is a clinically recognized agent in cardiac care, with a history of use spanning over 150 years. It is a first-line therapy for the acute relief of chest discomfort.

The primary goal of this medication is to help increase the supply of blood and oxygen to the heart, which relieves or prevents pain. The drug acts through its potent ability to induce vasodilation, thereby reducing the heart's overall workload.

Regulatory References

  1. Learn more from the NIH
  2. See MedlinePlus Drug Information

What side effects are possible with Nitroglicerina Sicma?

Possible Side Effects and Safety Information

The safety profile of Nitroglycerin is defined by its strong action as a nitrate vasodilator. The adverse reactions are officially classified and largely involve the vascular and nervous systems, as documented in governmental regulatory sources such as the FDA Prescribing Information and the EMA SmPC.

Frequency-Classified Adverse Reactions

The most commonly reported effects are directly related to vasodilation. The official regulatory documents classify the following:

  • Very Common: Headache (often described as throbbing or severe and dose-related).
  • Common: Dizziness, Hypotension (low blood pressure), Tachycardia (fast heart rate), Paresthesia (tingling/numbness), and Flushing.

These effects are frequently observed at the start of therapy. The label notes that the severe headache typically subsides with continued use as tolerance to this specific effect develops. Gastrointestinal symptoms, such as nausea and vomiting, are also documented as common adverse reactions.

Clinically Significant Safety Information

Official labeling addresses several serious or clinically significant safety considerations:

  • Serious Adverse Reactions: These include Severe Hypotension which may lead to Syncope (fainting) or Circulatory Collapse. A paradoxical worsening of chest pain, known as Increased Angina Pectoris, is also documented.
  • Absolute Contraindications: The use of nitroglycerin is strictly prohibited in patients taking Phosphodiesterase Type 5 (PDE5) Inhibitors (e.g., sildenafil) due to the risk of severe, life-threatening hypotension. It is also contraindicated in cases of Severe Anemia and conditions associated with Increased Intracranial Pressure.
  • Population Notes: Regulatory documents advise caution when selecting doses for older adults due to the greater likelihood of decreased physiological function, recommending a low starting dose. The safety of the drug during pregnancy and lactation is not fully established.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Nitroglicerina Sicma results primarily from excessive vasodilatation, which leads to severe hypotension (very low blood pressure). Urgent medical attention is required if any signs of overdose occur, as this condition can be life-threatening.

Documented Overdose Manifestations

Symptoms of an overdose are consequences of pronounced vascular effects and may include a severe throbbing headache, vertigo, confusion, vomiting, and sometimes a rapid or slow heartbeat.

Critical Overdose Risks

A specific risk associated with excessive exposure is methemoglobinemia, a blood disorder that impairs the oxygen-carrying capacity of red blood cells. Clinical signs of methemoglobinemia include the skin, lips, or nail beds turning a bluish or cold, clammy appearance.

Required Emergency Actions

In the event of a known or suspected overdose, the medicinal product must be immediately discontinued. Emergency management focuses on supportive treatment, including continuous clinical supervision and vital sign monitoring. For severe hypotension, initial actions involve keeping the patient supine with the head lowered, and administering intravenous fluids to restore central fluid volume. For clinically significant methemoglobinemia, a specific antidote such as methylene blue may be required after determining methemoglobin levels.

Therapeutic Uses of Nitroglicerina Sicma

What Nitroglicerina Sicma Treats: Main Uses and Benefits

The sublingual form of this medication is commonly used for the management and prevention of chest pain episodes due to Coronary Artery Disease (CAD). Its therapeutic use is established for the rapid relief of symptoms associated with heart-related chest pain.

The primary roles generally include providing symptomatic relief during acute episodes of Angina Pectoris, and the medication may be relevant for situational prophylaxis for patients managing Stable Ischemic Heart Disease. This medication addresses symptom clusters that may become intense or disruptive, such as pressure, heaviness, or squeezing in the chest.

It is applied in clinical settings that involve acute or unstable symptom patterns, typically when episodes are predictable, and may be part of a strategy for situational prophylaxis before anticipated triggers like moderate physical exertion or emotional tension. Its use assists with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Supportive Management for Anginal Pain

This medication is relevant for easing symptoms linked to organ-specific functional stress, specifically in conditions where symptoms may intensify temporarily.

Regulatory References

  1. NIH DailyMed Full Prescribing Information

Eligibility and Restrictions for Use

The eligibility for using Nitroglicerina Sicma (sublingual Nitroglycerin) is strictly defined by regulatory documents, which establish clear contraindications and limitations based on specific patient populations and existing conditions.

Populations and Conditions that Prohibit Use

Use is absolutely contraindicated (must not be used) in patients who are simultaneously taking Phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil or tadalafil) or Soluble Guanylate Cyclase (sGC) stimulators (such as riociguat). Concomitant use with these medications is prohibited due to the risk of severe, life-threatening hypotension.

Use is also contraindicated in patients with:

  • Severe Anemia
  • Increased Intracranial Pressure (ICP)
  • Acute Circulatory Failure or Shock
  • Known Hypersensitivity to nitroglycerin or other nitrates.

Age and Specific Population Status

Population Category Official Regulatory Status
Pediatric Patients Safety and effectiveness have not been established.
Geriatric Patients Use should be cautious, reflecting the potential for age-related decline in organ function.
Pregnancy Data are insufficient to determine drug-associated risk of birth defects or miscarriage.
Lactation It is not known if the drug is present in human milk or if it affects the infant.

Use with Caution

Use is restricted or requires special caution in patients with conditions like Hypertrophic Obstructive Cardiomyopathy, Constrictive Pericarditis, or Aortic/Mitral Stenosis, and in patients who are volume-depleted, due to the risk of severe hypotension.

What should I know about interactions with other medicines?

The interaction profile for this medication is defined by the significant risk of synergistic blood pressure changes and documented effects on the clearance of co-administered medicines.

Contraindicated Combinations

The co-administration of this medication is strictly prohibited with all Phosphodiesterase Type 5 (PDE-5) Inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil) and Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat). This restriction is mandatory due to the potential for severe, life-threatening hypotension resulting from the potentiation of the drug’s vasodilatory effects.

Pharmacodynamic and Exposure-Altering Interactions

There is a documented risk of additive hypotensive effects when co-administered with other blood pressure-lowering agents, including Antihypertensive Drugs (such as Beta-blockers and Calcium Channel Blockers) and Phenothiazines. Similarly, co-use with alcohol may officially cause hypotension.

  • Aspirin may decrease the clearance of nitroglycerin, thereby enhancing its hemodynamic effects.
  • Co-administration with Ergot Alkaloids (e.g., Dihydroergotamine) must be avoided because the drug significantly increases the oral bioavailability of these substances, raising the official risk of ergotism.
  • The drug is also documented to reduce the anticoagulant effect of intravenous Heparin and decrease the thrombolytic effect of Alteplase, which requires monitoring.

Mechanism of Action

The drug functions as a prodrug, requiring enzymatic conversion within the vessel wall to yield the signaling molecule Nitric Oxide (NO). This NO directly stimulates the enzyme soluble Guanylate Cyclase (sGC), which rapidly increases the second messenger cyclic GMP (cGMP). This molecular cascade is the fundamental step that leads to the relaxation of vascular smooth muscle. Activation of the cGMP pathway causes widespread relaxation with a dominant effect leading to venodilation. This physiological change increases the blood-holding capacity of the veins, thereby lowering the volume and pressure of venous return (Preload). The reduction in preload is the key hemodynamic consequence of the mechanism to reduce Myocardial Wall Stress and lower the heart’s overall Oxygen Demand. Additionally, the mechanism involves the relaxation of large coronary arteries, which facilitates the distribution of oxygenated blood. The mechanism is subject to a limitation known as Nitrate Tolerance, where continuous activation may impair the function of the activating enzyme (mtALDH-2), reducing the rate of NO release and the magnitude of the resulting vasodilation.

Dosage and Administration Information

Instruction Map: How to Use Nitroglicerina Sicma — Official Administration Guidelines

The usage of Nitroglicerina Sicma, which contains the active ingredient Nitroglycerin in a rapid-acting sublingual form, is governed by a precise, on-demand protocol. This guidance focuses strictly on the procedural aspects of administration, dosing, and timing.

Administration Scope Detail
Route of administration Sublingual (placed under the tongue) or Buccal Pouch (between the cheek and gum) for rapid absorption into the bloodstream.
Dosing schedule (Acute Relief) One dose (e.g., 0.4 mg tablet or spray) is administered at the first sign of symptoms. The dose may be repeated every 5 minutes if needed, but is limited to a maximum of 3 doses within a 15-minute period.
Prophylactic Timing A single dose may be taken 5 to 10 minutes prior to engaging in activities known to precipitate an acute anginal episode.
Special procedural conditions Administration must occur while the patient is at rest, preferably in the sitting position. The tablet must not be chewed, crushed, or swallowed, but must be allowed to dissolve fully.
Age-group rules Safety and effectiveness in pediatric patients have not been established in clinical documentation.

Official Use Protocol Structure

The medicine is classified for as-needed (intermittent) use and is not intended for continuous daily scheduled therapy. This use-pattern constraint helps to manage the risk of developing nitrate tolerance. The procedural structure defines three critical steps: first, establishing a state of rest; second, administering the sublingual dose without altering the formulation; and third, adhering to the sequential 5-minute dosing interval. Failure to obtain relief after the third dose initiates the final instruction: seeking prompt emergency medical assistance. This protocol ensures standardized use.

Recent Clinical Evidence

Research evidence / Overview of studies for Nitroglicerina Sicma


Evidence for the Acute Relief of Anginal Chest Pain

The research on this medication involves Randomized Controlled Trials (RCTs) and systematic reviews focusing on adult individuals with Angina Pectoris. These studies were used in research exploring how physical discomfort and physiological changes evolve during episodes of heightened symptoms. Researchers monitored the time elapsed until patients reported a change in their anginal discomfort, and the findings support the clinical management strategy for these acute episodes. The foundational nature of this evidence aligns with a regulatory evidence level of High for this indication. A key limitation is that safety and effectiveness are not established in pediatric patients.


Evidence for Situational Prevention of Angina

Research for the prophylactic (preventive) use was evaluated in placebo-controlled, short-term crossover RCTs. These studies research examined individuals with Chronic Stable Angina who experienced symptoms predictably during activity. Outcomes related to daily functioning or activity level were measured, such as the period of time a patient was able to exercise before specific signs of cardiac stress were noted. Findings describe patterns observed in the studies where outcomes measured during exertion differed between the group that received the drug and the control group.

A significant limitation is that the research only addresses situational use, and the study results apply only to the populations studied. There is also a known pharmacological observation that potential reduced response, or tolerance, was associated with non-intermittent administration in related research.


Limitations and Research Gaps

Because this formulation was evaluated in research focusing on rapid action, follow-up durations were limited to short periods. Therefore, long-term effects are not fully established. Beyond the lack of data for pediatric use, the initial pivotal trials did not include sufficient numbers of subjects aged 65 and over to definitively characterize their response patterns. Research highlights that the data for certain groups remain insufficient regarding long-term use and that findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Nitroglycerin Sublingual Tablets Full Prescribing Information (DailyMed)
  2. Nitroglycerin. In: StatPearls [Internet] (General overview, history, clinical recognition)
  3. Nitroglycerin Sublingual: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Nitroglicerina Sicma (FAQ)


Q: How long does it usually take for Nitroglicerina Sicma to start working?

Official product information indicates that the onset of action is very rapid, typically beginning within approximately one to three minutes after sublingual administration. This quick action is what makes the sublingual form suitable for the management of acute symptoms.


Q: Why does Nitroglicerina Sicma sometimes cause dizziness?

Dizziness is listed as one of the common effects noted in the official safety profile. According to regulatory sources, this is a result of the drug's strong vasodilatory action (relaxation of blood vessels), which can lead to a temporary lowering of blood pressure.


Q: Are there different forms of Nitroglicerina Sicma, like pills or patches?

The active ingredient, nitroglycerin, is available in multiple formulations. Regulatory documents confirm rapid-acting forms like sublingual tablets and sprays are used for acute episodes. Other forms, such as long-acting capsules or patches, exist but are separate products used for different therapeutic goals.


Q: What should I avoid doing right after using Nitroglicerina Sicma?

Regulatory instructions state that administration is to occur while the patient is at rest, preferably in the sitting position, to minimize the risk of lightheadedness or fainting due to potential blood pressure reduction. Furthermore, the label describes avoiding eating, drinking, or rinsing the mouth for 5 to 10 minutes immediately following sublingual use.


Q: Why do some people feel flushed after using Nitroglicerina Sicma?

Regulatory safety information lists flushing (a warm, reddening sensation) as a common side effect. Studies and official information link this effect directly to the drug's primary function of relaxing and widening the blood vessels, a process known as vasodilation.


Q: Is it normal for the container of Nitroglicerina Sicma to be made of glass?

Yes, the specific type of container is important for maintaining the drug's effectiveness. Official storage requirements describe keeping the tablets in their original, tightly-sealed glass container, which is typically amber-colored, to protect them from light and moisture.


Q: Does the medicine have an expiration date I need to watch out for?

Like all medications, the product has an expiration date printed on the packaging. Additionally, regulatory guidance often describes the importance of discarding and replacing sublingual tablets after a certain period of time (e.g., several months) once the container is first opened to maintain potency.


Q: What is the difference between Nitroglicerina Sicma and similar nitrate drugs?

Both this medicine and other nitrates (such as Isosorbide) belong to the same pharmacological class of nitrate vasodilators. The key difference is that this formulation is classified as a rapid-acting, intermittent treatment for acute episodes, while others are often long-acting for continuous daily preventative therapy.


Q: Can I take Nitroglicerina Sicma while drinking coffee?

Official regulatory warnings focus on specific drug-to-drug interactions and the use of alcohol. No specific caution or interaction warning is provided in official documentation regarding the use of this medication with coffee or other non-alcoholic beverages.


Q: What happens if I stop taking Nitroglicerina Sicma suddenly?

This sublingual formulation is classified for as-needed, intermittent use and is not a continuous daily scheduled treatment. Concerns about sudden discontinuation or withdrawal are typically associated with long-acting formulations and are not described in the regulatory guidance for this specific intermittent product.


Q: Are there any specific foods I should avoid while using this medicine?

Official warnings describe avoiding the combination of this medicine with alcohol due to the risk of severe blood pressure lowering. No specific warnings related to the intake of non-alcoholic foods or drinks are provided in the official documentation.


Q: Can Nitroglicerina Sicma be used by people with diabetes?

Official documentation lists specific conditions that absolutely prohibit or restrict the use of this medicine, such as severe anemia or increased intracranial pressure. Diabetes is not listed as one of these specific absolute contraindications in the regulatory documents.


Q: How long does the effect of Nitroglicerina Sicma usually last?

Studies and official information indicate that the significant pharmacological effects of the sublingual form are typically present for approximately 30 to 60 minutes following administration.


Q: Can I carry Nitroglicerina Sicma with me when I travel?

Official storage instructions describe keeping the medicine in its original container, protected from moisture and extreme heat. It is necessary that any travel adheres to these stability requirements to ensure the product's effectiveness is maintained.


Q: Why do official sources sometimes mention caution for people with glaucoma?

Official safety documents list closed-angle glaucoma as a contraindication for use. This is often due to the potential for the drug's vasodilatory effect to increase intracranial pressure, a condition which can be linked to changes in pressure in the eye.


Q: Does Nitroglicerina Sicma cause fatigue or tiredness?

While not listed as a common effect, official safety information documents have noted reports of weakness or unusual tiredness associated with the use of this medication. These effects are sometimes related to the drug's ability to lower blood pressure.

How should Nitroglicerina Sicma be stored and disposed of?

How to Store and Dispose of Nitroglicerina Sicma

This section outlines the official, mandatory storage and disposal requirements for nitroglycerin products, based on governmental regulatory documents.

Storage Requirement Official Classification
Temperature Controlled Room Temperature: 20°C–25°C (68°F–77°F)
Protection Must be protected from moisture and light
Container Must be kept in the original, tightly capped container

Official Storage and Handling

Nitroglycerin must be stored at the required controlled room temperature and kept away from extreme heat, direct sunlight, and ignition sources to preserve its stability. It is mandatory to keep the medication in the original container, which must be tightly sealed after each use to protect potency from ambient moisture.

Disposal and Child Safety

Keep this medication strictly out of the reach of children. Unused or expired product must be disposed of according to all applicable local and state pharmaceutical waste regulations. It is prohibited to dispose of unused medicine down the drain or through household trash; instead, utilize a drug take-back program or follow local guidelines for proper disposal.

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

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