liothyronine sodium

FDA Drug Profile — Cytomel, liothyronine sodium, Liothyronine Sodium

liothyronine sodium is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including Cytomel, liothyronine sodium, Liothyronine Sodium. Available dosage form: tablet.

Drug Details

Generic Name
liothyronine sodium
Brand Names
Cytomel, liothyronine sodium, Liothyronine Sodium
Application Number
NDA010379
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
10
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
LIOTHYRONINE SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Liothyronine 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 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 are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyroid-Stimulating Hormone (TSH) Suppression Liothyronine sodium tablets 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 are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use Liothyronine sodium tablets 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 may induce hyperthyroidism [see Warnings and Precautions ( 5.4 )] . Liothyronine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.