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-Stimulating 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: â¢ 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 tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. â¢ Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets is L-thyroxine (T4) indicated for: â¢ Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1) â¢ Pituitary Thyrotropin (Thyroid-Stimulating 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.
16 HOW SUPPLIED/STORAGE AND HANDLING Levothyroxine Sodium Tablets, USP are supplied as follows: Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 25 orange/Caplet â25â and âGG/331â 0781-5180-92 0781-5180-10 50 white/ Caplet â50â and âGG/332â 0781-5181-92 0781-5181-10 75 violet/ Caplet â75â and âGG/333â 0781-5182-92 0781-5182-10 88 Olive green/ Caplet â88â and âGG/334â 0781-5183-92 0781-5183-10 100 yellow/ Caplet â100â and âGG/335â 0781-5184-92 0781-5184-10 112 Rose/ Caplet â112â and âGG/336â 0781-5185-92 0781-5185-10 125 brown/ Caplet â125â and âGG/337â 0781-5186-92 0781-5186-10 137 turquoise/ Caplet â137â and âGG/330â 0781-5191-92 0781-5191-10 150 blue/ Caplet â150â and âGG/338â 0781-5187-92 0781-5187-10 175 Lilac/ Caplet â175â and âGG/339â 0781-5188-92 0781-5188-10 200 pink/ Caplet â200â and âGG/340â 0781-5189-92 0781-5189-10 300 green/ Caplet â300â and âGG/341â 0781-5190-92 0781-5190-10 Storage Conditions Store at 25Â°C (77Â°F); excursions permitted to 15Â° to 30Â° C (59Â° to 86Â° F) [see USP Controlled Room Temperature]. Levothyroxine sodium tablets should be protected from light and moisture.
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