levothyroxine sodium 0.025 mg oral tablet
1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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 ( 5.1 )] . Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablet is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, 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.
lupin pharmaceuticals, inc.
ROUND GREEN L 27
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
LEVOTHYROXINE SODIUM tablets USP are round, colored, scored and debossed with following debossing details on one side and break-line on other side. They are supplied as follows: Strength (mcg) Color/Shape Debossing Details NDC# for bottles of 90 NDC # for bottles of 100 NDC # for bottles of 500 NDC # for bottles of 1000 25 peach/round L15 68180-965-09 68180-965-01 68180-965-02 68180-965-03 50 white/round L16 68180-966-09 68180-966-01 68180-966-02 68180-966-03 75 violet/round L17 68180-967-09 68180-967-01 68180-967-02 68180-967-03 88 olive/round L19 68180-968-09 68180-968-01 68180-968-02 68180-968-03 100 yellow/round L20 68180-969-09 68180-969-01 68180-969-02 68180-969-03 112 Rose/round L21 68180-970-09 68180-970-01 68180-970-02 68180-970-03 125 tan/round L22 68180-971-09 68180-971-01 68180-971-02 68180-971-03 137 turquoise/round L23 68180-972-09 68180-972-01 68180-972-02 68180-972-03 150 blue/round L24 68180-973-09 68180-973-01 68180-973-02 68180-973-03 175 lilac/round L25 68180-974-09 68180-974-01 68180-974-02 68180-974-03 200 pink/round L26 68180-975-09 68180-975-01 68180-975-02 68180-975-03 300 green/round L27 68180-976-09 68180-976-01 68180-976-02 68180-976-03 Storage and Handling 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 USP should be protected from light and moisture.
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