WARNINGS AND PRECAUTIONS
Tolerance
Excessive use may lead to the development of tolerance. Only the smallest number of doses required for effective relief of the acute anginal attack should be used [see
DOSAGE AND ADMINISTRATION (2)].
As tolerance to other forms of nitroglycerin develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is reduced.
Hypotension
Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The 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.
The benefits of NitroMist in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use NitroMist in these conditions, careful clinical or hemodynamic monitoring must be used because of the possibility of hypotension and tachycardia.
Hypertrophic Cardiomyopathy
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
Headache
Nitroglycerin produces dose-related headaches, which may be severe. Tolerance to headaches occurs.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy category C: Animal reproduction and teratogenicity studies have not been conducted with NitroMist or nitroglycerin sublingual tablets. It is also not known whether NitroMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. A teratogenicity study was conducted in the third mating of F0 generation female rats administered dietary nitroglycerin for gestation day 6 to day 15 at dose levels used in the 3-generation reproduction study. In offspring of the high-dose nitroglycerin group, increased incidence of diaphragmatic hernias and decreased hyoid bone ossification were seen. The latter finding probably reflects delayed development rather than a potential teratogenic effect, thus indicating no clear evidence of teratogenicity of nitroglycerin.
There are no adequate and well controlled studies in pregnant women. NitroMist should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NitroMist is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
Geriatric Use
Clinical studies of NitroMist did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than 65 years) patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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