LEVOXYL® Indications and Usage

(levothyroxine sodium)

1 INDICATIONS AND USAGE

Hypothyroidism

LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression

LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.

Limitations of Use:

  • LEVOXYL 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 LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4)].
  • LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

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Indications and Usage

1 INDICATIONS AND USAGE

Hypothyroidism

LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression

LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.

Limitations of Use:

  • LEVOXYL 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 LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4)].
  • LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
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