Levothyroxine Sodium 0.1 MG Oral Tablet
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 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. Levothyroxine sodium tablets is 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.
Sandoz Inc.
OVAL YELLOW 100 GG 335
100 GG 335 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Levothyroxine Sodium Tablets, USP are supplied as follows: Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 25 orange/Caplet “25†and “GG/331†0781-5180-92 0781-5180-10 50 white/ Caplet “50†and “GG/332†0781-5181-92 0781-5181-10 75 violet/ Caplet “75†and “GG/333†0781-5182-92 0781-5182-10 88 olive green/ Caplet “88†and ‘GG/334†0781-5183-92 0781-5183-10 100 yellow/ Caplet “100†and “GG/335†0781-5184-92 0781-5184-10 112 Rose/ Caplet “112†and “GG/336†0781-5185-92 0781-5185-10 125 brown/ Caplet “125†and “GG/337†0781-5186-92 0781-5186-10 137 turquoise/ Caplet “137†and “GG/330†0781-5191-92 0781-5191-10 150 blue/ Caplet “150†and “GG/338†0781-5187-92 0781-5187-10 175 lilac/ Caplet “175†and “GG/339†0781-5188-92 0781-5188-10 200 pink/ Caplet “200†and “GG/340†0781-5189-92 0781-5189-10 300 green/ Caplet “300†and “GG/341†0781-5190-92 0781-5190-10 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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