NITROSTAT

What it is

NITROSTAT is a sublingual tablet containing 300 micrograms or 400 micrograms of glyceryl trinitrate as the active ingredient. Glyceryl trinitrate works by relaxing vascular smooth muscle and produces, in a dose-related manner, dilation of both arterial and venous beds.

Approved indications

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

Dosing overview

One sublingual tablet is administered under the tongue at the first sign of an acute anginal attack. The tablet should be allowed to dissolve without swallowing. One additional sublingual tablet may be administered every 5 minutes until relief is obtained, with no more than three sublingual tablets recommended within a 15-minute period. NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

Key safety warnings

Severe hypotension, particularly with upright posture, may occur with small doses of glyceryl trinitrate, particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive. Hypotension induced by glyceryl trinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension including nausea, vomiting, weakness, pallor, perspiration and collapse or 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. As tolerance to other forms of glyceryl trinitrate develops, the effects of sublingual glyceryl trinitrate on exercise tolerance, although still observable, are somewhat blunted. Excessive dosages of glyceryl trinitrate may produce severe headaches. 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 the vasodilatory effects of glyceryl trinitrate should avoid potentially hazardous tasks such as driving or operating machinery unless it is known that this medication does not affect their ability to engage in these activities.

Contraindications

NITROSTAT is contraindicated in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. NITROSTAT is contraindicated in patients who are taking soluble guanylate cyclase stimulators, such as riociguat, as concomitant use can cause hypotension. NITROSTAT is contraindicated in patients with severe anemia. NITROSTAT should not be used in patients with possible increased intracranial pressure. NITROSTAT is contraindicated in patients who are allergic to glyceryl trinitrate, other nitrates or nitrites or any excipient. NITROSTAT is contraindicated in patients with acute circulatory failure or shock.

PBS listing

Information on PBS listing for NITROSTAT is not provided in the available documents.

Regulatory history

NITROSTAT was first registered on the ARTG on 30 June 2025, with two registered variants: ARTG 438870 (300 microgram sublingual tablets) and ARTG 438851 (400 microgram sublingual tablets).