LIOTHYRONINE SODIUM tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Teva Pharmaceuticals USA, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 adrenal

Product samenvatting:

Liothyronine Sodium Tablets USP are supplied as follows: 5 mcg: White, round, unscored, flat faced radius edge tablets, debossed “TV” on one side and debossed “1L” on the other side, available in bottles of 100 tablets (NDC 0093-2179-01). 25 mcg: White, round, scored, flat faced radius edge tablets, debossed “TV” on the unscored side and debossed “2L” on the scored side, available in bottles of 100 tablets (NDC 0093-2178-01). 50 mcg: White, round, scored, flat faced radius edge tablets, debossed “TV” on the unscored side and debossed “3L” on the scored side, available in bottles of 100 tablets (NDC 0093-2180-01). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
TEVA PHARMACEUTICALS USA, 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).
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2, 1.3)
7/2019
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)7/2019
Contraindications (4)
7/2019
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)
7/2019
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 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