Levothyroxine Sodium 0.05 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 Tablets are 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
alvogen, inc.
OVAL WHITE 50 T 4
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levothyroxine sodium 50 mcg
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
LEVOTHYROXINE SODIUM Tablets, in the shape of caplet are supplied as follows (Table 11): Table 11.
LEVOTHYROXINE SODIUM Tablet Presentations Strength (mcg) Color Tablet Markings NDC# for bottles of 90 NDC# for bottles of 1,000 25 mcg orange "T|4" and "25" 47781-640-90 47781-640-10 50 mcg white "T|4" and "50" 47781-643-90 47781-643-10 75 mcg violet "T|4" and "75" 47781-646-90 47781-646-10 88 mcg Mint green "T|4" and "88" 47781-649-90 47781-649-10 100 mcg yellow "T|4" and "100" 47781-651-90 47781-651-10 112 mcg Rose "T|4" and "112" 47781-654-90 47781-654-10 125 mcg brown "T|4" and "125" 47781-657-90 47781-657-10 137 mcg Deep blue "T|4" and "137" 47781-659-90 47781-659-10 150 mcg Light blue "T|4" and "150" 47781-662-90 47781-662-10 175 mcg lilac "T|4" and "175" 47781-665-90 47781-665-10 200 mcg pink "T|4" and "200" 47781-668-90 47781-668-10 300 mcg green "T|4" and "300" 47781-671-90 47781-671-10 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect
LEVOTHYROXINE SODIUM Tablets from light and moisture.
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