levothyroxine sodium 50 mcg
1 INDICATIONS AND USAGE Levothyroxine Sodium Tablets are L-thyroxine (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. 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 Tablets 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.
PD-Rx Pharmaceuticals, Inc.
OVAL WHITE 50 T 4
50 T 4 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Levothyroxine Sodium Tablets, in the shape of caplet are supplied as follows: Strength Color Tablet Markings 50 mcg white "T|4" and "50" NDC# 72789-109-30 Bottles of 30 72789-109-90 Bottles of 90 75 mcg violet "T|4" and "75" NDC# 72789-104-90 Bottles of 90 Storage Conditions Store at 25°C (77°F); excursions permitted to 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Levothyroxine Sodium Tablets should be protected from light and moisture.
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