liothyronine sodium
Drug Details
- Generic Name
- liothyronine sodium
- Brand Names
- Liothyronine Sodium, liothyronine sodium, Cytomel
- Application Number
- NDA010379
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 10
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- LIOTHYRONINE SODIUM
Indications and Usage
1 INDICATIONS AND USAGE LIOMNY 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 LIOMNY is 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 LIOMNY is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. 1.3 Thyroid Suppression Test LIOMNY is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use LIOMNY is 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 LIOMNY may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. LIOMNY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.