Medicine guide

Nitrostat

.4 mg · Tablet

Prescription only
Nitrate Vasodilator

Active substance: Nitroglycerin
Used in: Heart, blood pressure and circulation
Made by: Proficient Rx LP
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 · 2019-11-01

What it is

Nitrate Vasodilator

Used for

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

The label’s usual adult dose

If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended.

Full directions ↓

Do not take it if

Nitroglycerin is contraindicated in patients who are allergic to it.

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 2026-10-02

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

From the official label · 2019-11-01 · DailyMed

How it works

From this product’s own US prescribing label.

The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle.
Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds.

Half-life36–32 min

Mostly cleared after≈ 2.8 hfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2019-11-01

Do not take it if

Nitroglycerin is contraindicated in patients who are allergic to it.
Sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.
Administration of NITROSTAT is contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates.
Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulator riociguat.
Concomitant use can cause hypotension.

Quoted from the official label, section “Contraindications”.

How to take it

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

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack.
The dose may be repeated approximately every 5 minutes until relief is obtained.
If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended.
NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.

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

Other warnings

The benefits of sublingual nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established.
If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used because of the possibility of hypotension and tachycardia.
General Only
the smallest dose required for effective relief of the acute anginal attack should be used.
Excessive use may lead to the development of tolerance.
NITROSTAT tablets are intended for sublingual or buccal administration and should not be swallowed.
Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin.
This drug should therefore be used with caution in patients who may be volume-depleted or who, for whatever reason, are already hypotensive.
Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to other forms of nitroglycerin develops, the effects of sublingual nitroglycerin on exercise tolerance, although still observable, is blunted.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance rarely occurs.
Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Several clinical trials of nitroglycerin patches or infusions in patients with angina pectoris have evaluated regimens that incorporated a 10- to 12-hour nitrate free interval.
In some of these trials, an increase in the frequency of anginal attacks during the nitrate free interval was observed in a small number of patients.
In one trial, patients had decreased exercise tolerance at the end of the nitrate interval.
Hemodynamic rebound has been observed only rarely; on the other hand, few studies were so designed that rebound, if it had occurred, would have been detected.
Nitrate tolerance as a result of sublingual nitroglycerin administration is probably possible, but only in patients who maintain high continuous nitrate levels for more than 10 or 12 hours daily.
Such use of sublingual nitroglycerin would entail administration of scores of tablets daily and is not recommended.
The drug should be discontinued if blurring of vision or drying of the mouth occurs.
Excessive dosage of nitroglycerin may produce severe headaches.
Information for Patients NITROSTAT is a sublingual tablet and should not be chewed, crushed, or swallowed.
Drug Interactions Concomitant use of NITROSTAT with soluble guanylate cyclase stimulators is contraindicated (see CONTRAINDICATIONS ).
Drug/Laboratory Test Interactions Nitrates may interfere with the Zlatkis-Zak color reaction, causing a false report of decreased serum cholesterol.
Carcinogenesis, Mutagenesis, Impairment of Fertility Animal carcinogenesis studies with sublingually administered nitroglycerin have not been performed.
Carcinogenicity potential of nitroglycerin was evaluated in rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years.
Rats developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes.
At high dose, the incidences of hepatocellular carcinomas in males was 48% and in females was 33%, compared to 0% in untreated controls.
Incidences of testicular tumors were 52% vs. 8% in controls.
Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.
Nitroglycerin was mutagenic in Ames tests performed in 2 different laboratories.
Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, PO, or in ex vivo cytogenetic tests in rat and dog cells.
In a 3-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F 0 generation, with treatment continuing through successive F 1 and F 2 generations.
The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings.
No specific effect on the fertility of the F 0 generation was seen.
Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males.
In this 3-generation study, there was no clear evidence of teratogenicity.
Pregnancy Category B Animal reproduction and teratogenicity studies have not been conducted with nitroglycerin sublingual tablets.
Nursing Mothers It is not known whether nitroglycerin is excreted in human milk.
Pediatric Use The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
Geriatric Use Clinical studies of NITROSTAT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
General Only
the smallest dose required for effective relief of the acute anginal attack should be used.
Excessive use may lead to the development of tolerance.
NITROSTAT tablets are intended for sublingual or buccal administration and should not be swallowed.
Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin.
This drug should therefore be used with caution in patients who may be volume-depleted or who, for whatever reason, are already hypotensive.
Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to other forms of nitroglycerin develops, the effects of sublingual nitroglycerin on exercise tolerance, although still observable, is blunted.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance rarely occurs.
Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Several clinical trials of nitroglycerin patches or infusions in patients with angina pectoris have evaluated regimens that incorporated a 10- to 12-hour nitrate free interval.
In some of these trials, an increase in the frequency of anginal attacks during the nitrate free interval was observed in a small number of patients.
In one trial, patients had decreased exercise tolerance at the end of the nitrate interval.
Hemodynamic rebound has been observed only rarely; on the other hand, few studies were so designed that rebound, if it had occurred, would have been detected.
Nitrate tolerance as a result of sublingual nitroglycerin administration is probably possible, but only in patients who maintain high continuous nitrate levels for more than 10 or 12 hours daily.
Such use of sublingual nitroglycerin would entail administration of scores of tablets daily and is not recommended.
The drug should be discontinued if blurring of vision or drying of the mouth occurs.
Excessive dosage of nitroglycerin may produce severe headaches.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Category B Animal reproduction and teratogenicity studies have not been conducted with nitroglycerin sublingual tablets.
However, teratology studies conducted in rats and rabbits with topically applied nitroglycerin ointment at dosages up to 80 mg/kg/day and 240 mg/kg/day, respectively revealed no toxic effects on dams or fetuses.
There are no adequate and well-controlled studies in pregnant women.
Nitroglycerin should be given to a pregnant woman only if clearly needed.
It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.

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

Other medicines

Concomitant use of NITROSTAT with soluble guanylate cyclase stimulators is contraindicated (see CONTRAINDICATIONS ).
Concomitant use of nitrates and alcohol may cause hypotension.
The vasodilatory and hemodynamic effects of nitroglycerin may be enhanced by concomitant administration of aspirin.
Intravenous administration of nitroglycerin decreases the thrombolytic effect of alteplase.
Therefore, caution should be observed in patients receiving sublingual nitroglycerin during alteplase therapy.
Intravenous nitroglycerin reduces the anticoagulant effect of heparin and activated partial thromboplastin times (APTT) should be monitored in patients receiving heparin and intravenous nitroglycerin.
It is not known if this effect occurs following single sublingual nitroglycerin doses.
Tricyclic antidepressants (amitriptyline, desipramine, doxepin, others) and anticholinergic drugs may cause dry mouth and diminished salivary secretions.
This may make dissolution of sublingual nitroglycerin difficult.
Increasing salivation with chewing gum or artificial saliva products may prove useful in aiding dissolution of sublingual nitroglycerin.
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.
Administration of nitroglycerin is contraindicated in patients who are using PDE-5 inhibitors (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride).
These compounds have been shown to potentiate the hypotensive effects of organic nitrates.
A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.

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.

Hemodynamic Effects:
The effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension.
These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; tachycardia; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has been subject to controlled study as a therapy of nitroglycerin overdose.
Because the 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.
Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.
The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.
In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard.
Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
Methemoglobinemia:
Methemoglobinemia has been rarely reported in association with organic nitrates.
The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial PO 2 .
Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.
If methemoglobinemia is present, intravenous administration of methylene blue, 1 to 2 mg/kg of body weight, may be required.

Quoted from the official label, section “Overdosage”.

Use in children

The 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 of NITROSTAT 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 the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting 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

Headache that may be severe and persistent may occur immediately after use.
Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients.
Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses.
Syncope due to nitrate vasodilatation has been reported.
Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

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

What to discuss with your doctor

NITROSTAT is a sublingual tablet and should not be chewed, crushed, or swallowed.
If possible, patients should sit down when taking NITROSTAT tablets and should use caution when returning to a standing position.
This eliminates the possibility of falling due to lightheadedness or dizziness.
One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack.
The dose may be repeated approximately every 5 minutes until relief is obtained.
If chest pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended.
NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.
Nitroglycerin may produce a burning or tingling sensation when administered sublingually; however, the ability to produce a burning or tingling sensation should not be considered a reliable method for determining the potency of the tablets.
Headaches can sometimes accompany treatment with nitroglycerin.
In patients who get these headaches, the headaches may be a marker of the activity of the drug.
Treatment with nitroglycerin may be associated with lightheadedness upon standing, especially just after rising from a recumbent or seated position.
This effect may be more frequent in patients who have also consumed alcohol.
Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

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

What it looks like and how it is packed

NITROSTAT is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.4 mg:
Coded "N" on one side and "4" on the other.
NDC 63187-884-25—Bottle of 25
Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP].

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

How to store it

Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP].

Quoted from the official label, section “Storage and Handling”.

What is in it

NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF.
Nitroglycerin, an organic nitrate, is a vasodilating agent.
The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:
Molecular weight:
Chemical Structure

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.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

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 (25)

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

Showing 25 of 25

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

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Every strength and form (18)

Details

Made by	Proficient Rx LP
Active substance	Nitroglycerin
Used in	Heart, blood pressure and circulation
Strength	.4 mg
Form	Tablet
Route	Sublingual
Packs	25 TABLET in 1 BOTTLE
NDC	63187-884

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).

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Other strengths and forms

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

Tablet6 products
- .3 mg
- .4 mg4
  .4 mg · 4 companies
  - A-S Medication Solutions
  - Henry Schein, Inc.
  - Proficient Rx LP · this page
  - Viatris Specialty LLC
- .6 mg

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