NITROLINGUAL

What it is

NITROLINGUAL contains glyceryl trinitrate, an organic nitrate vasodilating agent. The active ingredient is 1,2,3 propanetriol trinitrate with molecular formula C3H5N3O9. It is formulated as a pump-actuated aerosol spray delivering 400 micrograms per metered dose.

Approved indications

— Acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Dosing overview

One metered dose is administered sublingually at the first sign of an acute anginal attack and allowed to dissolve without swallowing. Additional doses may be administered every 5 minutes until relief is obtained. No more than three doses are recommended within a 15-minute period. If pain persists after three doses in a 15-minute period, or if the pain differs from typical angina, prompt medical attention should be sought. NITROLINGUAL may be used prophylactically 5 to 10 minutes before activities likely to precipitate an acute attack.

Key safety warnings

The benefits of glyceryl trinitrate in acute myocardial infarction or congestive heart failure have not been established. If used in these conditions, particular attention to hemodynamic monitoring and clinical status is required because of the possibility of hypotension and tachycardia. Severe hypotension, particularly with upright posture, may occur with small doses, especially in patients with constrictive pericarditis, aortic or mitral stenosis, volume-depleted patients, or those already hypotensive. Symptoms of severe hypotension including nausea, vomiting, weakness, pallor, perspiration and syncope may occur even with therapeutic doses. Tolerance to the vascular and anti-anginal effects of glyceryl trinitrate, and cross-tolerance to other nitrates and nitrites may occur. Only the smallest dose required for effective relief should be used, as excessive use may lead to tolerance development. Glyceryl trinitrate produces dose-related headaches, especially at the start of therapy, which may be severe and persist but usually subside with continued use. Glyceryl trinitrate may cause dizziness, vertigo and syncope. Patients with marked sensitivity to its vasodilatory effects should avoid potentially hazardous tasks such as driving or operating machinery.

Contraindications

NITROLINGUAL must not be used in patients taking PDE-5 inhibitors such as avanafil, sildenafil, tadalafil or vardenafil, as concomitant use can cause severe hypotension, syncope, or myocardial ischemia. It must not be used with soluble guanylate cyclase stimulators such as riociguat, as concomitant use can cause hypotension. It is contraindicated in severe anaemia, as large doses may cause oxidation of haemoglobin to methaemoglobin and exacerbate anaemia. NITROLINGUAL should not be used in patients with possible increased intracranial pressure, such as cerebral haemorrhage or traumatic brain injury. It is contraindicated in patients allergic to glyceryl trinitrate, other nitrates or nitrites, or any excipient. It is contraindicated in acute circulatory failure or shock.

PBS listing

NITROLINGUAL sublingual spray 400 micrograms per dose, 200 doses is listed on the PBS as 3 items with unrestricted and restricted supply options. The ex-manufacturer price is A$11.75.

Regulatory history

NITROLINGUAL was first approved on 30 June 2025. The product was registered on the ARTG as a pump spray formulation (ARTG 308842) on 19 October 2018 under licence category RE.