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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]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Nitroglycerin (Sublingual tablet) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Nitroglycerin (Sublingual tablet) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
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.[15][16]
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Nitroglycerin (Sublingual tablet) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Nitroglycerin (Sublingual tablet) in the drug label.
There is limited information regarding Patient Counseling Information of Nitroglycerin (Sublingual tablet) in the drug label.
Precautions with Alcohol
Alcohol-Nitroglycerin (Sublingual tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
The contents of this FDA label are provided by the National Library of Medicine.
↑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. ISSN1558-3597. PMID23256914. Unknown parameter |coauthors= ignored (help)
↑Jugdutt, B. I. (1992-09-24). "Role of nitrates after acute myocardial infarction". The American Journal of Cardiology. 70 (8): 82–87B. ISSN0002-9149. PMID1529930.
↑Schneider, W. (1991). "Nitrate therapy in heart failure". Cardiology. 79 Suppl 2: 5–13. ISSN0008-6312. PMID1760830. Unknown parameter |coauthors= ignored (help)
↑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. ISSN0009-7322. PMID3139326. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0002-8703. PMID6408917. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0009-7322. PMID6413087. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑Lauretti, G. R. (1999-03). "Transdermal nitroglycerine enhances spinal sufentanil postoperative analgesia following orthopedic surgery". Anesthesiology. 90 (3): 734–739. ISSN0003-3022. PMID10078674. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0002-9270. PMID9317059. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0020-7292. PMID10802078. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0029-7844. PMID19701035. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0270-9139. PMID3086204. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN1438-8812. PMID19670137. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0960-7692. PMID9819872. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN1234-1010. PMID14523338. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
↑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. ISSN0022-3468. PMID10626860. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)