LIOTHYRONINE SODIUM tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)

Dostępny od:

Mayne Pharma Commercial LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Liothyronine sodium tablets, USP (round, flat, white to off-white) are supplied as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
MAYNE PHARMA COMMERCIAL LLC
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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).
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 tablets are 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 orally once daily and
individual dosage according to patient
response and laboratory findings ( 2.1)
See full prescribing information for recommended dosage for
hy