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Adverse reactions to oral nitroglycerin dosage forms, particularly headache and hypotension, are generally dose-related. In clinical trials at various doses of nitroglycerin, the following adverse effects have been observed: Headache, which may be severe and persistent, is the most commonly reported side effect of nitroglycerin with an incidence on the order of about 50% in some studies. Cutaneous vasodilation with flushing may occur. Transient episodes of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension, may occasionally develop. Occasionally, an individual may exhibit marked sensitivity to the hypotensive effects of nitrates and severe responses (nausea, vomiting, weakness, restlessness, pallor, perspiration and collapse) may occur even with therapeutic doses. Drug rash and/or exfoliative dermatitis have been reported in patients receiving nitrate therapy. Nausea and vomiting appear to be uncommon.
Nitrolingual® Pumpspray (nitroglycerin lingual spray) given to 51 chronic stable angina patients in single doses of 0.4, 0.8 and 1.6 mg as part of a double-blind, 5-period single-dose cross-over study exhibited an adverse event profile that was generally mild to moderate. Adverse events occurring at a frequency greater than 2% included: headache, dizziness, and paresthesia. Less frequently reported events in this trial included ( < 2%): dyspnea, pharyngitis, rhinitis, vasodilation, peripheral edema, asthenia, and abdominal pain.
Read the Nitrolingual Pumpspray (nitroglycerin lingual spray) Side Effects Center for a complete guide to possible side effects
Alcohol may enhance sensitivity to the hypotensive effects of nitrates. Nitroglycerin acts directly on vascular muscle. Therefore, any other agents that depend on vascular smooth muscle as the final common path can be expected to have decreased or increased effect depending upon the agent.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and oral controlled-release nitroglycerin were used in combination. Dose adjustments of either class of agents may be necessary.
Concomitant use of nitric oxide donors (like Nitrolingual® Pumpspray (nitroglycerin lingual spray) ) and certain drugs for the treatment of erectile dysfunction (phosphodiesterase inhibitors) can amplify their vasodilatory effects, resulting in severe hypotension. The concomitant use of these drugs is contraindicated (see CONTRAINDICATIONS) and alternative therapies should be used to treat acute angina episodes.
Last reviewed on RxList: 11/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Nitrolingual Pumpspray Information
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