levothyroxine sodium 112 ug
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 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 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
preferred pharmaceuticals inc.
ROUND PINK P 6
P 6 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING All tablets having functional scoring.
LEVOTHYROXINE SODIUM, USP tablets are supplied as follows (Table 11): Table 11:
LEVOTHYROXINE SODIUM Tablet Presentations Strength (mcg) Tablet Description NDC# for bottles of 30 NDC # for bottles of 90 NDC # for bottles of 100 88 round shaped, olive colored, uncoated tablets, break line on both side and debossed with "P" and "4" on one side and plain on other side. 68788-7943-3 68788-7943-9 68788-7943-1 112 round shaped, Rose colored, uncoated tablets, break line on both side and debossed with "P" and "6" on one side and plain on other side. 68788-7942-3 68788-7942-9 68788-7942-1 125 round shaped, brown colored, uncoated tablets, break line on both side and debossed with "P" and "7" on one side and plain on other side. 68788-7945-3 68788-7945-9 68788-7945-1 Storage Conditions Store
LEVOTHYROXINE SODIUM tablets at 20°C to 25°C (68°F to 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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