Isosorbide dinitrate contraindications: Difference between revisions
(Created page with "__NOTOC__ {{Isosorbide dinitrate}} {{CMG}}; {{AE}} {{PB}} <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ISORDIL (ISOSORBIDE DINITRATE) TABLET...") |
No edit summary |
||
| Line 3: | Line 3: | ||
{{CMG}}; {{AE}} {{PB}} | {{CMG}}; {{AE}} {{PB}} | ||
==Contraindications== | |||
===Carcinogenesis, Mutagenesis, Impairment of Fertility=== | |||
No long-term studies in animals have been performed to evaluate the carcinogenic potential of ISDN. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed ISDN at 25 or 100 mg/kg/day. | |||
===Pregnancy=== | |||
Pregnancy Category C. At oral doses 35 and 150 times the maximum recommended human daily dose, ISDN has been shown to cause a dose-related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women.ISDN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. | |||
===Nursing Mothers=== | |||
It is not known whether ISDN is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ISDN is administered to a nursing woman. | |||
===Pediatric Use=== | |||
Safety and effectiveness in pediatric patients have not been established. | |||
===Geriatric Use=== | |||
Clinical studies of ISDN 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. | |||
Revision as of 03:50, 31 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]
Contraindications
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of ISDN. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed ISDN at 25 or 100 mg/kg/day.
Pregnancy
Pregnancy Category C. At oral doses 35 and 150 times the maximum recommended human daily dose, ISDN has been shown to cause a dose-related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women.ISDN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether ISDN is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ISDN is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of ISDN 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.
References
- ↑ "ISORDIL (ISOSORBIDE DINITRATE) TABLET [BTA PHARMACEUTICALS, INC.]". Retrieved 30 January 2014.