levothyroxine sodium 125 mcg
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 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.
Teva Pharmaceuticals, Inc.
OVAL BROWN T V 125
T V 125 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
LEVOTHYROXINE SODIUM tablets, USP are flat, beveled edge capsule shaped scored tablets and are supplied as follows (Table 11): Table 11:
LEVOTHYROXINE SODIUM Tablets, USP Presentations Strength Color /Shape debossed Tablet Markings NDC # for bottles of 90 NDC # for bottles of 100 NDC # for bottles of 1000 25 mcg orange/ capsule shaped 25 on the unscored side and T bisect V on the scored side, with side scores 0480-8682-98 0480-8682-01 0480-8682-10 50 mcg white/ capsule shaped 50 on the unscored side and T bisect V on the scored side, with side scores 0480-8687-98 0480-8687-01 0480-8687-10 75 mcg violet/ capsule shaped 75 on the unscored side and T bisect V on the scored side, with side scores 0480-8690-98 0480-8690-01 0480-8690-10 88 mcg olive/ capsule shaped 88 on the unscored side and T bisect V on the scored side, with side scores 0480-8693-98 0480-8693-01 0480-8693-10 100 mcg yellow/ capsule shaped 100 on the unscored side and T bisect V on the scored side, with side scores 0480-8701-98 0480-8701-01 0480-8701-10 112 mcg Rose/ capsule shaped 112 on the unscored side and T bisect V on the scored side, with side scores 0480-8704-98 0480-8704-01 0480-8704-10 125 mcg brown/ capsule shaped 125 on the unscored side and T bisect V on the scored side, with side scores 0480-8707-98 0480-8707-01 0480-8707-10 137 mcg turquoise/ capsule shaped 137 on the unscored side and T bisect V on the scored side, with side scores 0480-8710-98 0480-8710-01 0480-8710-10 150 mcg blue/ capsule shaped 150 on the unscored side and T bisect V on the scored side, with side scores 0480-8715-98 0480-8715-01 0480-8715-10 175 mcg lilac/ capsule shaped 175 on the unscored side and T bisect V on the scored side, with side scores 0480-8718-98 0480-8718-01 0480-8718-10 200 mcg pink/ capsule shaped 200 on the unscored side and T bisect V on the scored side, with side scores 0480-8722-98 0480-8722-01 0480-8722-10 300 mcg green/ capsule shaped 300 on the unscored side and T bisect V on the scored side, with side scores 0480-8725-98 0480-8725-01 0480-8725-10 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]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.
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