Nitroglycerin (Sublingual tablet)

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Nitroglycerin (Sublingual tablet)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Overview

Nitroglycerin (Sublingual tablet) is a anti-anginal vasodilator that is FDA approved for the {{{indicationType}}} of angina pectoris due to coronary artery disease. Common adverse reactions include hypotension, flushing, dizziness, headache, and lightheadedness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Relief of Angina Pectoris
  • Dosing Information
  • 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Congestive Heart Failure, Myocardial Infarction with Complication
  • Developed by: ACC/AHA
  • Class of Recommendation: Class IIa
  • Strength of Evidence: Category B
  • Dosing Information
  • Following acute myocardial infarction, early (less than 10 hours after onset) nitrate therapy resulted in limitations of infarct progression and arrhythmias and lowered the incidences of new congestive heart failure and early death.
  • Conversion to oral nitrates (isosorbide is best studied) or alternative routes of nitroglycerin administration should generally be accomplished within 24 to 48 hours.[1][2][3][4]
  • In the immediate treatment of severe left ventricular failure following acute myocardial infarction, nitroglycerin combined with dobutamine lowered abnormally elevated left ventricular filling pressure and augmented left ventricular pump function resulting in optimal hemodynamics more beneficially than either therapy alone.[5][6]

Non–Guideline-Supported Use

Postoperative Pain
  • Dosing Information
  • Addition of transdermal nitroglycerin 5 mg/24 hours to intrathecal sufentanil in patients receiving knee surgery decreases the 24-hour analgesic requirement. However, transdermal nitroglycerin alone did not demonstrate a significant analgesic effect.[7]
Chronic Anal Fissure
  • Dosing Information
  • Nitroglycerin 0.2% ointment was effective for healing chronic anal fissures compared with placebo with no significant difference in fissure recurrence after 9 months.[8]
Biliary Tract Disorder
  • Dosing Information
  • Sublingual doses of 0.3 to 0.6 mg administered at the beginning of the procedure aided successful cannulation of the common bile duct, insertion of the Dormia basket, and removal of stones 4 to 11 mm in diameter.[9]
Dysmenorrhea
  • Dosing Information
  • Pain intensity was reduced and fewer analgesics were used compared with placebo, but headache incidence was increased in women with primary dysmenorrhea who received nitroglycerin patch 0.1 mg/hr for 24 hours on days 1, 2, and 3 of each cycle.[10]
External Cephalic Version with Tocolysis
  • Dosing Information
  • IV nitroglycerin improved the success rate of external cephalic version in nulliparous and multiparous women.[11]
Gastrointestinal Hemorrhage
  • Dosing Information
  • Combined therapy with vasopressin and nitroglycerin was more effective than vasopressin alone in controlling acute variceal hemorrhage, and nitroglycerin prevented cardiotoxic effects of vasopressin infusions.[12]
Prophylaxis of Post-ERCP Pancreatitis
  • Dosing Information
  • Nitroglycerin prophylaxis reduced the incidence of postendoscopic retrograde cholangiopancreatography pancreatitis in patients with primary biliary disease.[13]
Preeclampsia
  • Dosing Information
  • Transdermal nitroglycerin 5 mg/24 hours initiated at 24 to 26 weeks gestation and continued for an average of 60 days increased the likelihood of a complication-free outcome with no significant effect on maternal blood pressure, uterine artery resistance index, or umbilical artery and middle cerebral artery pulsatility indices.[14]
Pulmonary Edema
  • Dosing Information
  • Sublingual nitroglycerin (0.4 to 2.4 mg at 5- to 10-minute intervals) was beneficial in the emergency treatment of pulmonary edema.[15]
Retained Placenta
  • Dosing Information
  • IV bolus nitroglycerin 500 mcg resulted in spontaneously uterine relaxation and placentas were extracted without complications.[16]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nitroglycerin (Sublingual tablet) in pediatric patients.

Non–Guideline-Supported Use

Chronic Anal Fissure
  • Dosing Information
  • Nitroglycerin ointment applied topically healed chronic anal fissures in 8 weeks without evidence of fissure recurrence on follow-up and was more effective in healing of the fissure than lidocaine or placebo.[17][18]

Contraindications

  • Allergic reactions to organic nitrates are extremely rare, but they do occur. 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.

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.

Precautions

  • 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nitroglycerin (Sublingual tablet) in the drug label.

Postmarketing Experience

  • 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.

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nitroglycerin (Sublingual tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nitroglycerin (Sublingual tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nitroglycerin (Sublingual tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nitroglycerin (Sublingual tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous
  • Transdermal patch
  • Ointment

Monitoring

There is limited information regarding Monitoring of Nitroglycerin (Sublingual tablet) in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Nitroglycerin (Sublingual tablet) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nitroglycerin (Sublingual tablet) in the drug label.

Pharmacology

There is limited information regarding Nitroglycerin (Sublingual tablet) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Nitroglycerin (Sublingual tablet)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nitroglycerin (Sublingual tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Nitroglycerin (Sublingual tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nitroglycerin (Sublingual tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nitroglycerin (Sublingual tablet) in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Nitroglycerin (Sublingual tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

  • 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.

Precautions with Alcohol

  • 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.
  • Concomitant use of nitrates and alcohol may cause hypotension.

Brand Names

  • Minitran®
  • Nitro-Bid®
  • Nitro-Dur®
  • Nitrolingual®
  • Nitrostat®
  • Nitrotab®
  • Nitrek®
  • NitroMist®
  • Nitrostat®[19]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ American College of Emergency Physicians (2013-01-29). "2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines". Journal of the American College of Cardiology. 61 (4): –78-140. doi:10.1016/j.jacc.2012.11.019. ISSN 1558-3597. PMID 23256914. Unknown parameter |coauthors= ignored (help)
  2. ↑ Jugdutt, B. I. (1992-09-24). "Role of nitrates after acute myocardial infarction". The American Journal of Cardiology. 70 (8): 82–87B. ISSN 0002-9149. PMID 1529930.
  3. ↑ Schneider, W. (1991). "Nitrate therapy in heart failure". Cardiology. 79 Suppl 2: 5–13. ISSN 0008-6312. PMID 1760830. Unknown parameter |coauthors= ignored (help)
  4. ↑ Jugdutt, B. I. (1988-10). "Intravenous nitroglycerin therapy to limit myocardial infarct size, expansion, and complications. Effect of timing, dosage, and infarct location". Circulation. 78 (4): 906–919. ISSN 0009-7322. PMID 3139326. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  5. ↑ Awan, N. A. (1983-07). "Effect of combined nitroglycerin and dobutamine infusion in left ventricular dysfunction". American Heart Journal. 106 (1 Pt 1): 35–40. ISSN 0002-8703. PMID 6408917. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  6. ↑ Loeb, H. S. (1983-10). "Beneficial effects of dopamine combined with intravenous nitroglycerin on hemodynamics in patients with severe left ventricular failure". Circulation. 68 (4): 813–820. ISSN 0009-7322. PMID 6413087. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  7. ↑ Lauretti, G. R. (1999-03). "Transdermal nitroglycerine enhances spinal sufentanil postoperative analgesia following orthopedic surgery". Anesthesiology. 90 (3): 734–739. ISSN 0003-3022. PMID 10078674. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  8. ↑ Carapeti, E. A. (1999-05). "Randomised controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate". Gut. 44 (5): 727–730. ISSN 0017-5749. PMC 1727506. PMID 10205213. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  9. ↑ Uchida, N. (1997-09). "Endoscopic lithotomy of common bile duct stones with sublingual nitroglycerin and guidewire". The American Journal of Gastroenterology. 92 (9): 1440–1443. ISSN 0002-9270. PMID 9317059. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  10. ↑ Moya, R. A. (2000-05). "Transdermal glyceryl trinitrate in the management of primary dysmenorrhea". International Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of Gynaecology and Obstetrics. 69 (2): 113–118. ISSN 0020-7292. PMID 10802078. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  11. ↑ Hilton, Jennifer (2009-09). "Intravenous nitroglycerin for external cephalic version: a randomized controlled trial". Obstetrics and Gynecology. 114 (3): 560–567. doi:10.1097/AOG.0b013e3181b05a19. ISSN 0029-7844. PMID 19701035. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  12. ↑ Gimson, A. E. (1986-06). "A randomized trial of vasopressin and vasopressin plus nitroglycerin in the control of acute variceal hemorrhage". Hepatology (Baltimore, Md.). 6 (3): 410–413. ISSN 0270-9139. PMID 3086204. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  13. ↑ Bai, Y. (2009-08). "Glyceryl trinitrate for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography: a meta-analysis of randomized, double-blind, placebo-controlled trials". Endoscopy. 41 (8): 690–695. doi:10.1055/s-0029-1214951. ISSN 1438-8812. PMID 19670137. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  14. ↑ Lees, C. (1998-11). "The efficacy and fetal-maternal cardiovascular effects of transdermal glyceryl trinitrate in the prophylaxis of pre-eclampsia and its complications: a randomized double-blind placebo-controlled trial". Ultrasound in Obstetrics & Gynecology: The Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology. 12 (5): 334–338. doi:10.1046/j.1469-0705.1998.12050334.x. ISSN 0960-7692. PMID 9819872. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  15. ↑ Bussmann, W. D. (1978-05-01). "Effect of sublingual nitroglycerin in emergency treatment of severe pulmonary edema". The American Journal of Cardiology. 41 (5): 931–936. ISSN 0002-9149. PMID 417614. Unknown parameter |coauthors= ignored (help)
  16. ↑ Peng, A. T. (1989-07). "Intravenous nitroglycerin for uterine relaxation in the postpartum patient with retained placenta". Anesthesiology. 71 (1): 172–173. ISSN 0003-3022. PMID 2502047. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  17. ↑ Simpson, John (2003-10). "The use of glyceryl trinitrate (GTN) in the treatment of chronic anal fissure in children". Medical Science Monitor: International Medical Journal of Experimental and Clinical Research. 9 (10): –123-126. ISSN 1234-1010. PMID 14523338. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  18. ↑ Tander, B. (1999-12). "A prospective, randomized, double-blind, placebo-controlled trial of glyceryl-trinitrate ointment in the treatment of children with anal fissure". Journal of Pediatric Surgery. 34 (12): 1810–1812. ISSN 0022-3468. PMID 10626860. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  19. ↑ "NITROSTAT (nitroglycerin) tablet".
  20. ↑ "http://www.ismp.org". External link in |title= (help)


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