Glyceryl trinitrate

ATC code

C01DA02

Therapeutic class

Vasodilator used in cardiac diseases · Organic nitrate

Forms

sublingual tablet, sublingual spray, transdermal patch, intravenous solution, ointment

Brand names

Natispray (ES) · Nitrostat (US) · Nitrolingual (US) · Trinitrine Mylan (FR) · Dermatrans (ES)

Overall confidence

medium

Regulatory sources consulted

aemps-cima-ft-63682
Clinical Pharmacology Knowledge Base
AHA/ACC Guidelines
Standard Pharmacopoeia

Approved indications

Acute treatment of angina pectoris attacks.
Short-term prophylaxis of angina pectoris induced by stress or exercise (use 5-10 minutes before activity).
Long-term prophylaxis of angina pectoris (using sustained-release forms like transdermal patches).
Treatment of perioperative hypertension; induction of controlled hypotension during surgery; treatment of congestive heart failure associated with myocardial infarction (intravenous form).

Contraindications

Absolute

Concomitant use of phosphodiesterase type 5 (PDE-5) inhibitors such as sildenafil, tadalafil, or vardenafil.
Hypersensitivity to nitroglycerin or other nitrates/nitrites.
Severe hypotension (systolic blood pressure < 90 mmHg), cardiogenic shock, or uncorrected hypovolemia.
Hypertrophic obstructive cardiomyopathy, severe aortic or mitral stenosis, constrictive pericarditis, or cardiac tamponade.
Severe anemia, increased intracranial pressure, or cerebral hemorrhage.

Clinical warnings

Major warning · Tolerance may develop with chronic use, especially with long-acting formulations. A nitrate-free interval (10-12h) is required to maintain efficacy. — AEMPS CIMA
May cause orthostatic hypotension, dizziness, and syncope, especially in elderly or volume-depleted patients. Alcohol may exacerbate this effect. — AEMPS CIMA

Drug interactions

HighSildenafilG04BE03
Mechanism: PDE-5 inhibition by sildenafil prevents cGMP breakdown, massively potentiating the vasodilatory effect of nitric oxide (released from nitroglycerin) and can cause severe, refractory, and potentially fatal hypotension.
Recommendation: Concomitant use is absolutely contraindicated. At least 24 hours should pass after the last dose of sildenafil before administering nitrates.
Clinical Practice Guideline
HighRiociguatC02KX05
Mechanism: Riociguat is a soluble guanylate cyclase (sGC) stimulator. Co-administration with nitrates can cause a synergistic increase in cGMP production, leading to a high risk of hypotension.
Recommendation: Concomitant use is contraindicated.
EMA SPC
ModerateLisinoprilC09AA03
Mechanism: Additive hypotensive effect. Both drugs lower blood pressure via different mechanisms (direct vasodilation vs. RAAS inhibition).
Recommendation: Monitor blood pressure, especially at treatment initiation or dose adjustment. Dose adjustment may be necessary.
Clinical Pharmacology Knowledge

Adverse events

Common (≥1%)

headache · dizziness · flushing · postural hypotension · reflex tachycardia

Rare but serious

severe hypotension · syncope · methemoglobinemia · paradoxical bradycardia · exfoliative dermatitis

Pregnancy and lactation

FDA category: C

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether it is excreted in human milk; use with caution.