levothyroxine sodium 50 ug
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: • 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‑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.
Proficient Rx LP
ROUND WHITE P 2
P 2 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING All tablets having functional scoring.
LEVOTHYROXINE SODIUM, USP tablets are supplied as follows: Strength (mcg) Tablet Description NDC# for bottles with child-resistant closure of 30 NDC# for bottles with child-resistant closure of 60 NDC# for bottles with child-resistant closure of 90 50 round shaped, white colored, uncoated tablets, break line on both side and debossed with "P" and "2" on one side and plain on other side. 71205-646-30 71205-646-60 71205-646-90 Storage Conditions Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].
LEVOTHYROXINE SODIUM tablets should be protected from light and moisture.
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