País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)
XGen Pharmaceuticals DJB, Inc.
LIOTHYRONINE SODIUM
LIOTHYRONINE 10 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.)
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
Abbreviated New Drug Application
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 Llegiu el document complet