Medicine guide

Nitroglycerin Lingual

400 ug · Spray

Prescription only
Nitrate Vasodilator

Active substance: Nitroglycerin
Used in: Heart, blood pressure and circulation
Made by: Padagis Israel Pharmaceuticals Ltd
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2022-09-01

What it is

Nitrate Vasodilator

Used for

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Do not take it if

Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). (4.1, 7.1)

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-03

92other products contain Nitroglycerin — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease (1).

From the official label · 2022-09-01 · DailyMed

How it works

From this product’s own US prescribing label.

Nitroglycerin forms free radical nitric oxide (NO), which activates guanylate cyclase, resulting in an increase of guanosine 3',5'-monophosphate (cyclic GMP) in smooth muscle and other tissues.
This eventually leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilatation.

Half-life40 min

Mostly cleared after≈ 3.3 hfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2022-09-01

Do not take it if

Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). (4.1, 7.1)
Severe anemia. (4.2)
Increased intracranial pressure. (4.3)
Hypersensitivity to Nitroglycerin Lingual Spray or to other nitrates or nitrites or any excipient. (4.4) 4.1 PDE-5-Inhibitors and sGC-Stimulators
Do not use Nitroglycerin Lingual Spray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ] .
Do not use Nitroglycerin Lingual Spray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia Nitroglycerin Lingual Spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 Increased Intracranial Pressure Nitroglycerin Lingual Spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g. cerebral hemorrhage or traumatic brain injury). 4.4 Hypersensitivity Nitroglycerin Lingual Spray is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. 4.5 Circulatory Failure and Shock Nitroglycerin Lingual Spray is contraindicated in patients with acute circulatory failure or shock.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

At the onset of an attack, administer onto or under the tongue. Repeat every 5 minutes as needed (2.1).
Do up to three metered sprays within a 15-minute period. If chest pain persists, advise prompt medical attention (2.1).
May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack (2.1). 2.1 Recommended Dosage Instruct the patient to administer one or two metered sprays (400 mcg of nitroglycerin per spray) at the onset of an attack onto or under the tongue. A spray may be repeated approximately every five minutes as needed. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists after a total of three sprays, advise prompt medical attention. Nitroglycerin Lingual Spray may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. 2.2 Priming The pump must be primed prior to the first use. Each metered spray of Nitroglycerin Lingual Spray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of five sprays. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks it can be adequately re-primed with one spray. If the product is not used within 3 months it can be adequately re-primed with up to five sprays. There are 60 or 200 metered sprays per bottle. The total number of available doses is dependent, however, on the number of sprays per use (1 or 2 sprays), and the frequency of priming. 2.3 Administration Instruct patients that during administration, the patient should rest, ideally in the sitting position. Hold the container vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. Spray the dose preferably onto or under the tongue by pressing the grooved-button firmly and the mouth closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. The medication should not be expectorated or the mouth rinsed for 5 to 10 minutes following administration. Instruct patients to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night [see Patient Information (17) ] . The amount of liquid remaining in the container should be checked periodically. The transparent container can be used for continuous monitoring of the consumption. With the container upright and level, check to be sure the end of the center tube extends below the level of the liquid. Once fluid falls below the level of the center tube, remaining sprays will not deliver intended dose.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Tolerance : Excessive use may lead to tolerance.
(5.1) Hypotension : Severe hypotension may occur.
(5.2)
5.1 Tolerance Excessive use may lead to the development of tolerance.
Only
the smallest number of doses required for effective relief of the acute angina attack should be used [see Dosage and Administration (2.1) ] .
5.2 Hypotension Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive.
Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses.
5.3 Hypertrophic Obstructive Cardiomyopathy Nitrate therapy may aggravate the angina caused by hypertrophic obstructive cardiomyopathy.
5.4 Headache Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persistent but usually subside with continued use.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage.
In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Data] .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.
Data Animal Data No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage.
In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Data] .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.
Data Animal Data No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 240 mg/kg/day for 13 days, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day for 11 days, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day for 13 days.
8.2 Lactation Risk summary Sublingual nitroglycerin has not been studied in lactating women.
It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition.
8.4 Pediatric Use Safety and effectiveness of nitroglycerin in pediatric patients have not been established.
8.5 Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients.
In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Antihypertensives: Possible additive hypotensive effects. (7.2)
Ergotamine:
increased bioavailability of ergotamine.
Avoid concomitant use (7.3) 7.1 PDE-5-Inhibitors and sGC-Stimulators Nitroglycerin Lingual Spray is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Nitroglycerin Lingual Spray is contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators. Concomitant use can cause hypotension. The time course and dose dependence of these interactions have not been studied, and use within a few days of one another is not recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. 7.2 Antihypertensives Patients receiving antihypertensive drugs, beta-adrenergic blockers, and nitrates should be observed for possible additive hypotensive effects. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Beta-adrenergic blockers blunt the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effects. If beta-blockers are used with nitroglycerin in patients with angina pectoris, additional hypotensive effects may occur. 7.3 Ergotamine Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore, patients receiving sublingual nitroglycerin should
avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

10.1 Signs and Symptoms, Methemoglobinemia Nitrate overdosage may result in:
severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse.
Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates.
The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.
10.2 Treatment of Overdosage As hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume.
No specific antagonist to the vasodilator effects of nitroglycerin is known.
Keep the patient recumbent in a shock position and comfortably warm.
Passive movement of the extremities may aid venous return.
Intravenous infusion of normal saline or similar fluid may also be necessary.
Administer oxygen and artificial ventilation, if necessary.
If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required unless the patient is known to have G-6-PD deficiency.
If an excessive quantity of Nitroglycerin Lingual Spray has been recently swallowed gastric lavage may be of use.
As epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage, it is not recommended for resuscitation.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients.
In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse reactions occurring at a frequency greater than 2% and greater than placebo included:
headache, dizziness, and paresthesia.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of nitroglycerin lingual spray and other nitroglycerin drugs.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.
Neurologic:
weakness, drowsiness Dermatologic:
cutaneous vasodilation, flushing, drug rash, exfoliative dermatitis Gastrointestinal:
nausea, vomiting Respiratory:
transient hypoxemia Cardiovascular:
tachycardia

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Manufactured By Padagis Yeruham, Israel Distributed By Padagis TM Allegan, MI 49010
www.padagis.com Rev 09-22 8A500 RC J6

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Lingual spray, 400 mcg per spray available in either 60 or 200 metered sprays per container. Lingual spray, 400 mcg per spray, available in 60 or 200 metered sprays per container (3).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Each box of Nitroglycerin Lingual Spray contains one glass bottle coated with orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 12 g (Net Contents) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming. Nitroglycerin Lingual Spray is available as:
60-dose (4.9 g) single bottle NDC 45802- 210 -01
200-dose (12 g) single bottle NDC 45802- 210 -02
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Note:
Nitroglycerin Lingual Spray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only

Quoted from the official label, section “How Supplied”.

What is in it

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins.
The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3 H 5 N 3 O 9 ).
The compound has a molecular weight of 227.09.
The chemical structure is:
CH 2 –ONO 2 | CH–ONO 2 | CH 2 –ONO 2 Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin.
This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue.
Inactive ingredients:
medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Alcohol (ethanol)dehydrated alcoholMatters for children, in pregnancy, in recovery and with some medicines.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (5)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 5 of 5

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (18)

Details

Made by	Padagis Israel Pharmaceuticals Ltd
Active substance	Nitroglycerin
Used in	Heart, blood pressure and circulation
Strength	400 ug
Form	Spray
Route	Oral
Packs	1 BOTTLE in 1 CARTON / 60 SPRAY in 1 BOTTLE · 1 BOTTLE in 1 CARTON / 200 SPRAY in 1 BOTTLE
NDC	45802-210

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Spray3 products
- 400 ug3
  400 ug · 3 companies
  - Allegis Pharmaceuticals, LLC
  - HF Acquisition Co LLC, DBA HealthFirst
  - Padagis Israel Pharmaceuticals Ltd · this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Glonoinum200CWithout prescriptionPellet Boiron · Nitroglycerin Glonoinum15CWithout prescriptionPellet Boiron · Nitroglycerin Glonoinum30CWithout prescriptionPellet Boiron · Nitroglycerin Glonoinum9CWithout prescriptionPellet Boiron · Nitroglycerin Glonoinum12CWithout prescriptionPellet Boiron · Nitroglycerin Glonoinum5CWithout prescriptionPellet Boiron · Nitroglycerin

See every product with Nitroglycerin