liothyronine sodium 5 ug
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 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 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 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 tablets 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.
sun pharmaceutical industries, inc.
ROUND WHITE 589
589 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LIOTHYRONINE SODIUM tablets, USP are white to off-white, circular, uncoated tablets. They are supplied as follows:
LIOTHYRONINE SODIUM tablets, containing 5 mcg liothyronine are debossed ‘589’ on one side and plain on other side. Bottles of 30 with child-resistant closure, NDC 62756-589-83 Bottles of 90 with child-resistant closure, NDC 62756-589-01 Bottles of 100 with child-resistant closure, NDC 62756-589-88 Bottles of 100, NDC 62756-589-08 Bottles of 1000, NDC 62756-589-18
LIOTHYRONINE SODIUM tablets, containing 25 mcg liothyronine are debossed ‘590’ on one side and breakline on other side. Bottles of 30 with child-resistant closure, NDC 62756-590-83 Bottles of 90 with child-resistant closure, NDC 62756-590-01 Bottles of 100 with child-resistant closure, NDC 62756-590-88 Bottles of 100, NDC 62756-590-08 Bottles of 1000, NDC 62756-590-18
LIOTHYRONINE SODIUM tablets, containing 50 mcg liothyronine are debossed ‘591’ on one side and breakline on other side. Bottles of 30 with child-resistant closure, NDC 62756-591-83 Bottles of 90 with child-resistant closure, NDC 62756-591-01 Bottles of 100 with child-resistant closure, NDC 62756-591-88 Bottles of 100, NDC 62756-591-08 Bottles of 1000, NDC 62756-591-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
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