The benefits of sublingual nitroglycerin in patients with acute myocardial
infarction or congestive heart failure have not been established. If one elects
to use nitroglycerin in these conditions, careful clinical or hemodynamic
monitoring must be used because of the possibility of hypotension and
in vivo dominant lethal assay with male rats treated with
doses up to about 363 mg/kg/day, PO, or in ex vivo
cytogenetic tests in rat and dog tissues.
In a 3-generation reproduction study, rats received dietary nitroglycerin at
doses up to about 434 mg/kg/day for 6 months prior to mating of the F0 generation with treatment continuing through successive
F1 and F2 generations. The high
dose was associated with decreased feed intake and body weight gain in both
sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent
generations, however, was attributed to increased interstitial cell tissue and
aspermatogenesis in the high-dose males. In this 3-generation study there was no
clear evidence of teratogenicity.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been
conducted with nitroglycerin sublingual tablets. Teratology studies in rats and
rabbits, however, were conducted with topically applied nitroglycerin ointment
at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on
dams or fetuses were seen at any dose tested.
There are no adequate and well-controlled studies in pregnant women.
Nitroglycerin should be given to a pregnant woman only if clearly needed.
It is not known whether nitroglycerin is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
nitroglycerin is administered to a nursing woman.
The safety and effectiveness of nitroglycerin in pediatric
patients have not been established.
Clinical studies of nitroglycerin tablets 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 the elderly and younger
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.