국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)
PD-Rx Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Liothyronine Sodium Tablets, USP are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Liothyronine Sodium Tablets, USP are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Liothyronine Sodium Tablets, USP are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - Liothyronine Sodium Tablets, USP 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, USP may induce hyperthyroidism [see Warnings and Precautions (5.4)]. - Liothyronine Sodium Tablets, USP are not indicated for treatment of hypoth
Liothyronine Sodium Tablets, USP (white to off-white, round, SC) are supplied as follows: 30 count 43063-884-30 Store between 15°C and 30°C (59°F and 86°F).
Abbreviated New Drug Application
LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LIOTHYRONINE SODIUM TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIOTHYRONINE SODIUM TABLETS, USP. LIOTHYRONINE SODIUM TABLETS, USP, 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 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) RECENT MAJOR CHANGES Indications and Usage ( 1.1, 1.2, 1.3) 12/2018 Dosage and Administration ( 2.1, 2.2, 2.3, 2.4, 2.5, 2.6) 12/2018 Contraindications ( 4) 12/2018 Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 12/2018 INDICATIONS AND USAGE Liothyronine sodium is an L-triiodothyronine (T3) indicated for: 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: - 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, USP orally once daily and individual dosage according to patient response and laboratory findings ( 2.1) See full prescribing information for recommended dosage for h 전체 문서 읽기