Nitroglycerin Lingual
Generic Name: nitroglycerin lingual
Brand Names:
Nitroglycerin Lingual
11 DESCRIPTION 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 (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is: Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin.
Overview
11 DESCRIPTION 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 (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is: Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin.
Uses
1 INDICATIONS & USAGE Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Dosage
2 DOSAGE & ADMINISTRATION 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.
Side Effects
6 ADVERSE REACTIONS 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 postapproval use of nitroglycerin lingual spray and other nitroglycerin drugs.
Interactions
7 DRUG INTERACTIONS 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 (PDE5). PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Do not use Nitroglycerin Lingual Spray in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. 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 cannot be recommended.
Warnings
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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)].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING NITROGLYCERIN LINGUAL SPRAY is supplied in the following dosage forms. NDC 51662-1393-1 NITROGLYCERIN LINGUAL SPRAY 400mcg PER SPRAY 60 METERED SPRAYS 4.9g NET CONTENTS BOXED HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Each box of Nitroglycerin Lingual Spray contains one glass bottle...
Frequently Asked Questions
What is Nitroglycerin Lingual used for?▼
1 INDICATIONS & USAGE Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
What are the side effects of Nitroglycerin Lingual?▼
6 ADVERSE REACTIONS 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 postapproval use of nitroglycerin lingual spray and other nitroglycerin drugs.
What are the important warnings for Nitroglycerin Lingual?▼
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.