LIOTHYRONINE SODIUM

5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular
Disease
Overtreatment with thyroid hormone may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility
and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients.

Initiate liothyronine sodium therapy in this population at lower doses than those recommended in younger individuals or in
patients without cardiac disease [see Dosage and Administration (2.3) and Use in Specific Populations (8.5)].
Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive
liothyronine sodium therapy. Monitor patients receiving concomitant Liothyronine Sodium Tablets, USP and
sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or
worsen, reduce or withhold the liothyronine sodium dose for one week and restart at a lower dose.
5.2 Myxedema Coma
Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in
unpredictable absorption of thyroid hormone from the gastrointestinal tract. Use of oral thyroid hormone drug products is
not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous
administration to treat myxedema coma.
5.3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency
Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating
glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with
adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with Liothyronine Sodium Tablets,
USP [see Contraindications (4)].
5.4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism
Liothyronine sodium has a narrow therapeutic index. Over- or undertreatment with liothyronine sodium may have negative
effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function,
emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of Liothyronine Sodium
Tablets, USP carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)] .
Monitor for the presence of drug or food interactions when using Liothyronine Sodium Tablets, USP and adjust the dose as
necessary [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
5.5 Worsening of Diabetic Control
Addition of thyroid hormone therapy in patients with diabetes mellitus may worsen glycemic control and result in
increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or
discontinuing Liothyronine Sodium Tablets, USP [see Drug Interactions (7.2)].
5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement
Increased bone resorption and decreased bone mineral density may occur as a result of thyroid hormone over-replacement,
particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and
urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid
hormone levels. Administer the minimum dose of Liothyronine Sodium Tablets, USP that achieves the desired clinical and
biochemical response to mitigate against this risk.