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warnings and cautions
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. 5.3 Hypertrophic Obstructive Cardiomyopathy Nitrate therapy may aggravate the angina caused by hypertrophic obstructive cardiomyopathy. 5.4 Headache Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persistent but usually subside with continued use.
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 post-approval use of Nitroglycerin Lingual Spray and other nitroglycerin drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. Neurologic: weakness, drowsiness Dermatologic: cutaneous vasodilation, flushing, drug rash, exfoliative dermatitits Gastrointestinal: nausea, vomiting Respiratory: transient hypoxemia Cardiovascular: tachycardia To report SUSPECTED ADVERSE REACTIONS, contact Jacksonville Pharmaceuticals, Inc. at 1-800-235-6203 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.