Mediclarum
Medicine guide

Nitrostat

.4 mg · Tablet

  • Prescription only
  • Nitrate Vasodilator
Active substance
Nitroglycerin
Made by
A-S Medication Solutions

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 · 2024-08-05

What it is

Nitrate Vasodilator

Used for
  • NITROSTAT is indicated for the acute relief of an attack or acute 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) stimulators. ( 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 2026-10-02
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

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

From the official label · 2024-08-05 · 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.

These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.

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 · 2024-08-05

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) stimulators. ( 4.1 , 7.1 )
  • Severe anemia ( 4.2 )
  • Increased intracranial pressure ( 4.3 )
  • Hypersensitivity to NITROSTAT or to other nitrates or nitrites or any excipient ( 4.4 )
  • Circulatory failure and shock ( 4.5 ) 4.1 PDE-5-Inhibitors and sGC-Stimulators
  • Do not use NITROSTAT in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ].
  • Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia NITROSTAT 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 NITROSTAT 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 NITROSTAT is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. 4.5 Circulatory Failure and Shock NITROSTAT 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.

  • Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. 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, seek prompt medical attention. NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet. Administer NITROSTAT at rest, preferably in the sitting position.
  • At the onset of an attack, administer one tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed. No more than 3 total tablets are recommended within a 15 minute period. ( 2 )
  • If chest pain persists after three tablets, seek prompt medical attention. ( 2 )
  • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. ( 2 )

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 dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates. 5.2 Hypotension Severe hypotension, particularly with upright posture, may occur 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 cardiomyopathy. 5.4 Headache Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persist 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 80 and 240 mg/kg/day, respectively, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day from gestation day 7-17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6-18.
  • 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 80 and 240 mg/kg/day, respectively, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day from gestation day 7-17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6-18.
  • 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.
  • 8.4 Pediatric Use The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
  • 8.5 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.
  • 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 “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Ergotamine: increased bioavailability of ergotamine.
  • Avoid concomitant use.
  • ( 7.2 )
  • 7.1 PDE-5-Inhibitors and sGC-Stimulators NITROSTAT 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.
  • NITROSTAT 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 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.
  • Aspirin Coadministration of nitroglycerin with high dose aspirin (1000 mg) results in increased exposure to nitroglycerin.
  • The vasodilatory and hemodynamic effects of nitroglycerin may be enhanced by concomitant administration of nitroglycerin with high dose aspirin.
  • Tissue-type plasminogen activator (t-PA) Concomitant administration of t-PA and intravenous nitroglycerin has been shown to reduce plasma levels of t-PA and its thrombolytic effect.

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 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

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

  • The following adverse reactions are discussed in more detail elsewhere in the label:
  • Hypotension [see Warnings and Precautions (5.2) ]
  • Headache [see Warnings and Precautions (5.4) ]
  • Hypersensitivity [see Contraindications (4.4) ] 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. Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling ( Patient Information ).
  • Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc.
  • NITROSTAT is a registered trademark of Viatris Specialty LLC, a Viatris Company.
  • UPJ:NTRST:R1 Revised: 2/2023

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

Strengths and forms

  • FORMS AND STRENGTHS NITROSTAT is supplied as white, round, flat-faced tablets in three strengths:
  • 0.3 mg (Coded with “N” on one side and “3” on the other) 0.4 mg (Coded with “N” on one side and “4” on the other) 0.6 mg (Coded with “N” on one side and “6” on the other) Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg ( 3 )

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

What it looks like and how it is packed

Product: 50090-7203 NDC: 50090-7203-0 25 TABLET in a BOTTLE / 1 in a CARTON

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

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:
  • Nitroglycerin Structural Formula

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.

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Details

Made byA-S Medication Solutions
Active substanceNitroglycerin
Used inHeart, blood pressure and circulation
Strength.4 mg
FormTablet
RouteSublingual
Packs1 BOTTLE in 1 CARTON / 25 TABLET in 1 BOTTLE
NDC50090-7203

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.

Same active substance

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