levothyroxine sodium 0.075 MG Oral Tablet LevoT
1 INDICATIONS AND USAGE LEVO-T is 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 Hypothyroidism LEVO-T is 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 LEVO-T is 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 LEVO-T is 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 LEVO-T may induce hyperthyroidism [see Warnings and Precautions (5.1)] . LEVO-T is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Neolpharma, Inc.
OVAL PURPLE GG 333 75
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LEVO-T (
LEVOTHYROXINE SODIUM, USP) tablets are supplied as follows (Table 11): Table 11. LEVO-T Tablet Presentations Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 25 orange/Caplet "25" and "GG/331" 55466-104-11 55466-104-19 50 white/ Caplet "50" and "GG/332" 55466-105-11 55466-105-19 75 violet/ Caplet "75" and "GG/333" 55466-106-11 55466-106-19 88 olive green/ Caplet "88" and 'GG/334" 55466-107-11 5466-107-19 100 yellow/ Caplet "100" and "GG/335" 55466-108-11 55466-108-19 112 Rose/ Caplet "112" and "GG/336" 55466-109-11 55466-109-19 125 brown/ Caplet "125" and "GG/337" 55466-110-11 55466-110-19 137 turquoise/ Caplet "137" and "GG/330" 55466-111-11 55466-111-19 150 blue/ Caplet "150" and "GG/338" 55466-112-11 55466-112-19 175 lilac/ Caplet "175" and "GG/339" 55466-113-11 55466-113-19 200 pink/ Caplet "200" and "GG/340" 55466-114-11 55466-114-19 300 green/ Caplet "300" and "GG/341" 55466-115-11 55466-115-19 Storage and Handling Store LEVO-T at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) (see USP Controlled Room Temperature). LEVO-T tablets should be protected from light and moisture.
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