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:

Aidarex Pharmaceuticals LLC

INN (International Name):

LIOTHYRONINE SODIUM

Composition:

LIOTHYRONINE 5 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Thyroid hormone drugs are indicated: - As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (pediatric patients, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see WARNINGS ). - As pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's) and multinodular goiter. - As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland

Product summary:

Rx Only Liothyronine Sodium Tablets, USP, 5 mcg, are white to off-white, round, flat, debossed "5" over "220" on one side and plain on the other in bottles of 30 and 90.   5 mcg 30's: NDC   33261-0964-30 5 mcg 90's: NDC   33261-0964-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
AIDAREX PHARMACEUTICALS LLC
----------
LIOTHYRONINE SODIUM TABLETS, USP
DESCRIPTION
Thyroid hormone drugs are natural or synthetic preparations containing
tetraiodothyronine (T ,
levothyroxine) sodium or triiodothyronine (T , liothyronine) sodium or
both. T and T are produced in
the human thyroid gland by the iodination and coupling of the amino
acid tyrosine. T contains four
iodine atoms and is formed by the coupling of two molecules of
diiodotyrosine (DIT). T contains three
atoms of iodine and is formed by the coupling of one molecule of DIT
with one molecule of
monoiodotyrosine (MIT). Both hormones are stored in the thyroid
colloid as thyroglobulin.
Thyroid hormone preparations belong to two categories: (1) natural
hormonal preparations derived from
animal thyroid, and (2) synthetic preparations. Natural preparations
include desiccated thyroid and
thyroglobulin. Desiccated thyroid is derived from domesticated animals
that are used for food by man
(either beef or hog thyroid), and thyroglobulin is derived from
thyroid glands of the hog. The United
States Pharmacopeia (USP) has standardized the total iodine content of
natural preparations. Thyroid
USP contains not less than (NLT) 0.17 percent and not more than (NMT)
0.23 percent iodine, and
thyroglobulin contains not less than (NLT) 0.7 percent of organically
bound iodine. Iodine content is
only an indirect indicator of true hormonal biologic activity.
Liothyronine Sodium Tablets, USP contain liothyronine
(L-triiodothyronine or LT ), a synthetic form of
a natural thyroid hormone, and is available as the sodium salt.
The structural and empirical formulas and molecular weight of
liothyronine sodium are given below.
Twenty-five mcg of liothyronine is equivalent to approximately 1 grain
of desiccated thyroid or
thyroglobulin and 0.1 mg of L-thyroxine.
Each round, white Liothyronine Sodium Tablet, USP contains
liothyronine sodium equivalent to
liothyronine as follows: 5 mcg debossed 5 and 220; 25 mcg scored and
debossed