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Ismotic (Isosorbide) - Warnings and Precautions



  1. With repeated doses, consideration should be given to maintenance of adequate fluid and electrolyte balance.
  2. If urinary output continues to decrease, the patient’s clinical status should be closely reviewed. Accumulation of ISMOTIC may result in overexpansion of the extracellular fluid.



For oral use only – not for injection. Repetitive doses should be used with caution particularly in patients with diseases associated with salt retention. Ensure that patient’s bladder has been emptied prior to surgery.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the potential of these effects.


Pregnancy Category B

Reproduction (fertility and teratology) studies have been performed in rats at doses approximately 5 times the recommended initial human dose of 1.5 gm/kg body weight and have revealed no evidence of impaired fertility or harm to the fetus due to isosorbide. Teratology studies have been performed with rabbits and rats given daily oral doses of isosorbide at 6.5 and 10 times, respectively, the recommended initial human dose during organogenesis without evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in breast milk, caution should be exercised when isosorbide is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Page last updated: 2006-03-23

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