LIOTHYRONINE SODIUM tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

American Health Packaging

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

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. Unit dose packages of 30 (3 x 10) NDC 60687-625-21 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
AMERICAN HEALTH PACKAGING
----------
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:
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
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 tablets