LIOTHYRONINE

1 INDICATIONS AND USAGE Liothyronine sodium is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) 1.1 Hypothyroidism Liothyronine Sodium Tablets, USP are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Liothyronine Sodium Tablets, USP are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. 1.3 Thyroid Suppression Test Liothyronine Sodium Tablets, USP are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use Liothyronine Sodium Tablets, USP are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Liothyronine Sodium Tablets, USP may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. Liothyronine Sodium Tablets, USP are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.