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Outline
What is the generic name?
LEVOTHYROXINE SODIUM
What is the Trade Name for LEVOTHYROXINE SODIUM?
Levothyroxine sodium
What are the Indications for LEVOTHYROXINE SODIUM?
- 1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‚ÄëStimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine 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 levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets are levothyroxine sodium (T4) indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1) Pituitary Thyrotropin (Thyroid‚ÄëStimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1) Limitations of Use: – Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. – Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
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References: https://open.fda.gov/
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