Nitroglycerin Lingual Spray (500 mcg per Spray, 200 Sprays)

Treatment of acute attacks of angina pectoris due to coronary artery disease [1][2][3]. Prophylaxis of angina induced by physical effort, emotional stress or exposure to cold, or before activities likely to precipitate an attack [1][2][3]. Not recommended in children and adolescents under 18 years (UK labelling) [1].

Spray one or two metered doses onto or under the tongue at the onset of an attack, or 5-10 minutes (US) / 2-3 minutes (UK) before an activity likely to cause angina [1][2][3]. Rest, preferably sitting; hold the container upright, valve uppermost, orifice close to the mouth; close the mouth immediately after each dose [1][2][3]. Do not inhale the spray; do not spit out or rinse the mouth for 5-10 minutes after administration [2][3]. Prime before first use until a fine mist appears; re-prime after 6 weeks without use (1 spray) and after 3 months (up to 5 sprays) [2][3]. Storage: do not store above 25 °C (UK) or store at 20-25 °C (US); do not refrigerate or freeze; do not pierce or burn the pressurised canister or spray towards a naked flame; keep out of the reach of children [1][2][3].

Dosage is expressed per spray; use the smallest number of sprays that gives relief to limit tolerance [1][2][3]. For the 500 mcg per spray product, the number of sprays per dose follows the approved product labelling [1][2].

Contraindicated with phosphodiesterase-5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) and with the soluble guanylate cyclase stimulator riociguat - severe hypotension, syncope or myocardial ischaemia may occur [1][2]. Also contraindicated in severe anaemia, increased intracranial pressure, hypersensitivity, acute circulatory failure or shock, severe hypotension (systolic below 90 mm Hg), constrictive pericarditis, aortic or mitral stenosis, and angina caused by hypertrophic obstructive cardiomyopathy [1][2]. Severe hypotension may occur even with small doses, especially on standing or in volume-depleted patients; paradoxical bradycardia and increased angina may accompany it [1][2]. Tolerance and cross-tolerance to other nitrates develop with excessive or continuous high-dose use; use the smallest effective number of sprays [1][2]. Headache is common and dose-related, especially at the start of therapy; flushing, dizziness and paresthesia are also reported [1][2][3]. Caution in pericardial tamponade, low filling pressures (acute myocardial infarction, left ventricular failure), orthostatic dysregulation, raised intracranial pressure, glaucoma, volume depletion from diuretics, severe hepatic or renal impairment and hypothyroidism [1]. Interactions: alcohol, antihypertensives, beta-blockers, calcium antagonists, vasodilators, tricyclic antidepressants and diuretics potentiate hypotension; avoid ergotamine; monitor heparin; high-dose aspirin increases nitroglycerin exposure [1][2]. Pregnancy: limited data are insufficient to establish risk; animal studies showed no adverse developmental effects at over 64 times the human dose - use only if clearly needed. Breast-feeding: excretion into milk is unknown; weigh benefit against risk [1][2]. Driving and machinery: the ability to react may be reduced; avoid driving or operating machines during treatment [1]. Other adverse reactions: syncope, orthostatic hypotension, tachycardia or bradycardia, nausea and vomiting, application-site burning or stinging, rash and exfoliative dermatitis, transient hypoxaemia [1][2][3]. Overdose: severe hypotension, throbbing headache, vertigo, palpitation, flushing, nausea and vomiting, syncope and rarely methemoglobinaemia; treatment - recumbent shock position, leg elevation, fluids, oxygen and intravenous methylthioninium chloride 1-2 mg/kg (avoid in G6PD deficiency); epinephrine is not recommended [1][2][3]. Prescription medicine (Rx only in the US; POM in the UK) [1][2]. For full prescribing information, refer to the approved product label [1][2][3].