LIOTHYRONINE SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

XGen Pharmaceuticals DJB, Inc.

INN (International Name):

LIOTHYRONINE SODIUM

Composition:

LIOTHYRONINE 10 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Liothyronine sodium injection (T 3 ) is indicated in the treatment of myxedema coma/precoma. Liothyronine sodium injection (T 3 ) can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef. Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency or untreated thyrotoxicosis. Thyroid hormone preparations are also generally contraindicated in patients with hypersensitivity to any of the active or extraneous constituents of these preparations; however, there is no well-documented evidence in the literature of true allergic or idiosyncratic reactions to thyroid hormone. Concomitant use of liothyronine sodium injection (T 3 ) and artificial rewarming of patients is contraindicated. (See PRECAUTIONS.)

Product summary:

Liothyronine sodium injection (T 3 ) is supplied in a single vial carton containing a 1mL vial at a concentration of 10 mcg/1mL (base). NDC number 39822-0151-1. Store between 2°C – 8°C (36°F – 46°F). Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised: May 2023 LS-AF-PI-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM INJECTION, SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
LIOTHYRONINE SODIUM INJECTION (T
)
RX ONLY
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 and released into the circulation. The major source of T
has been shown
to be peripheral deiodination of T
. T
is bound less firmly than T
in the serum, enters
peripheral tissues more readily, and binds to specific nuclear
receptor(s) to initiate
hormonal, metabolic effects. T
is the prohormone which is deiodinated to T
for
hormone activity.
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.
Liothyronine sodium injection (T
) contains liothyronine (L-triiodothyronine or L-T
), a
synthetic form of a natural thyroid hormone, as the sodium salt.
The structural and empirical formulas and molecular weight of
liothyronine sodium are
given below.
In euthyroid patients, 25 mcg of liothyronine is equivalent to
approximately 1 grain of
desiccated thyroid or thyroglobulin and 0.1 mg of L-thyroxine.
Each mL of liothyronine sodium injection (T
) in amber glass vials contains, in sterile
non-pyrogenic aqueous solution, liothyronine sodium equivalent to 10
mcg of
liothyro