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:

Preferred Pharmaceuticals Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)]. Risk Summary Experience with liothyronine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data). There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels ma

Podsumowanie produktu:

Liothyronine Sodium Tablets: 5 mcg - Round, white to off-white color tablets debossed “Σ” on one side and “18” on the other side. They are available in; bottles of 30s (NDC 68788-7269-3) bottles of 60s (NDC 68788-7269-6) bottles of 90s (NDC 68788-7269-9) Store between 15°C and 30°C (59°F and 86°F).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
PREFERRED PHARMACEUTICALS INC.
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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._
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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:
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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
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mcg, 25 mcg, 50 mcg (3)
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)
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)
Administer Liothyronine Sodium Tablets, USP orally once daily and
individual dosage according to
patient