País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)
Sun Pharmaceutical Industries, Inc.
ORAL
PRESCRIPTION DRUG
Liothyronine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Liothyronine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Liothyronine sodium tablets are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - Liothyronine 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 liothyronine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. - Liothyronine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Liothyronine sodium tablets are contraindicated in patients with uncorrected ad
Liothyronine sodium tablets, USP are white to off-white, circular, uncoated tablets. They are supplied as follows: Liothyronine sodium tablets, containing 5 mcg liothyronine are debossed ‘589’ on one side and plain on other side. Bottles of 30 with child-resistant closure, NDC 62756-589-83 Bottles of 90 with child-resistant closure, NDC 62756-589-01 Bottles of 100 with child-resistant closure, NDC 62756-589-88 Bottles of 100, NDC 62756-589-08 Bottles of 1000, NDC 62756-589-18 Liothyronine sodium tablets, containing 25 mcg liothyronine are debossed ‘590’ on one side and breakline on other side. Bottles of 30 with child-resistant closure, NDC 62756-590-83 Bottles of 90 with child-resistant closure, NDC 62756-590-01 Bottles of 100 with child-resistant closure, NDC 62756-590-88 Bottles of 100, NDC 62756-590-08 Bottles of 1000, NDC 62756-590-18 Liothyronine sodium tablets, containing 50 mcg liothyronine are debossed ‘591’ on one side and breakline on other side. Bottles of 30 with child-resistant closure, NDC 62756-591-83 Bottles of 90 with child-resistant closure, NDC 62756-591-01 Bottles of 100 with child-resistant closure, NDC 62756-591-88 Bottles of 100, NDC 62756-591-08 Bottles of 1000, NDC 62756-591-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LIOTHYRONINE SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIOTHYRONINE SODIUM TABLETS. LIOTHYRONINE SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1956 WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THYROID HORMONES, INCLUDING LIOTHYRONINE SODIUM TABLETS, SHOULD NOT BE USED FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS. DOSES BEYOND THE RANGE OF DAILY HORMONAL REQUIREMENTS MAY PRODUCE SERIOUS OR EVEN LIFE-THREATENING MANIFESTATIONS OF TOXICITY (6, 7.7, 10). INDICATIONS AND USAGE Liothyronine is an L-triiodothyronine (T3) indicated for: (1) Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (1.1) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer (1.2) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy (1.3) Limitations of Use: (1) Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1) Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1) DOSAGE AND ADMINISTRATION Administer liothyronine sodium tablets orally once daily and individual dosage according to patient response and laboratory findings (2.1) See full prescribing information for recommended dosage for hypothyroidism (2.2) TSH suppression in well-differentiated thyroid cancer (2.3) and for thyroid suppression test (2.4) When switching a patient to liothyronine sodium tablets discontinue levothyroxine therapy and initiate liothyronine sodium Llegiu el document complet