levothyroxine 300 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 is 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
aurobindo pharma limited
ROUND GREEN LV 300
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
LEVOTHYROXINE SODIUM Tablets, USP are supplied as follows:
LEVOTHYROXINE SODIUM Tablets, USP 137 mcg are round, biconvex, turquoise color, mottled tablet, debossed with “137” and partial bisect (functional) on one side and “LV” on the other side and are available as follows: Bottles of 90 NDC 59651-554-90 Bottles of 1,000 NDC 59651-554-99
LEVOTHYROXINE SODIUM Tablets, USP 150 mcg are round, biconvex, blue color, mottled tablet, debossed with “150” and partial bisect (functional) on one side and “LV” on the other side and are available as follows: Bottles of 90 NDC 59651-555-90 Bottles of 1,000 NDC 59651-555-99
LEVOTHYROXINE SODIUM Tablets, USP 175 mcg are round, biconvex, lilac color, mottled tablet, debossed with “175” and partial bisect (functional) on one side and “LV” on the other side and are available as follows: Bottles of 90 NDC 59651-556-90 Bottles of 1,000 NDC 59651-556-99
LEVOTHYROXINE SODIUM Tablets, USP 200 mcg are round, biconvex, pink color, mottled tablet, debossed with “200” and partial bisect (functional) on one side and “LV” on the other side and are available as follows: Bottles of 90 NDC 59651-557-90 Bottles of 1,000 NDC 59651-557-99
LEVOTHYROXINE SODIUM Tablets, USP 300 mcg are round, biconvex, green color, mottled tablet, debossed with “300” and partial bisect (functional) on one side and “LV” on the other side and are available as follows: Bottles of 90 NDC 59651-558-90 Bottles of 1,000 NDC 59651-558-99 Storage and Handling Store
LEVOTHYROXINE SODIUM tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
LEVOTHYROXINE SODIUM tablets, USP should be protected from light and moisture.
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