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:

Greenstone LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Liothyronine sodium is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Liothyronine sodium is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Liothyronine sodium is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - Liothyronine sodium is 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 may induce hyperthyroidism [see Warnings and Precautions (5.4)] . - Liothyronine sodium is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Liothyronine sodium is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)] . Risk Sum

Product summary:

Liothyronine sodium tablets (round, white to off-white) are supplied as follows: Store between 15°C and 30°C (59°F and 86°F).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIOTHYRONINE SODIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIOTHYRONINE SODIUM.
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, 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 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 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