LIOTHYRONINE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SIGMAPHARM LABORATORIES, LLC

INN (International Name):

LIOTHYRONINE SODIUM

Composition:

LIOTHYRONINE 5 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hypothyroidism during the recovery phase of s

Product summary:

Liothyronine Sodium Tablets, USP (white to off-white, round, SC) are supplied as follows: 30 count - 42794-018-08 60 count - 42794-018-10 90 count - 42794-018-12 100 count - 42794-018-02 1000 count - 42794-018-06 30 count - 42794-019-08 60 count - 42794-019-10 90 count - 42794-019-12 100 count - 42794-019-02 1000 count - 42794-019-06 30 count - 42794-020-08 60 count - 42794-020-10 90 count - 42794-020-12 100 count - 42794-020-02 1000 count - 42794-020-06 Store between 15°C and 30°C (59°F and 86°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
SIGMAPHARM LABORATORIES, LLC
----------
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