Thyrolar (Liothyronine Sodium / Levothyroxine Sodium) - Summary

THYROLAR SUMMARY

Thyrolar® Tablets (Liotrix Tablets, USP)

Thyrolar Tablets (Liotrix Tablets, USP) contain triiodothyronine (T3 liothyronine) sodium and tetraiodothyronine (T4 levothyroxine) sodium in the amounts listed in the “How Supplied” section. (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.

Thyrolar Tablets are indicated:

1. 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 (children, 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).
2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, sub-acute or chronic Iymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.
3. As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.

NEWS HIGHLIGHTS

Published Studies Related to Thyrolar (Liothyronine / Levothyroxine)

Efficacy of combined levothyroxine and liothyronine as compared with levothyroxine monotherapy in primary hypothyroidism: a randomized controlled trial. [2009]
OBJECTIVES: To examine the efficacy of combination therapy with levothyroxine and liothyronine in improvement of general health, psychological problems, and metabolic status in primary hypothyroidism... CONCLUSIONS: The data do not support the hypothesis that combined therapy improves the well-being and general health of patients.

Combined treatment with sertraline and liothyronine in major depression: a randomized, double-blind, placebo-controlled trial. [2007.06]
BACKGROUND: Antidepressant treatments that achieve a higher remission rate than those currently available are urgently needed. The thyroid hormone triiodothyronine may potentiate antidepressant effects. OBJECTIVE: To determine the antidepressant efficacy and safety of liothyronine sodium (triiodothyronine) when administered concurrently with the selective serotonin reuptake inhibitor sertraline hydrochloride to patients with major depressive disorder... CONCLUSIONS: These results demonstrate enhancement of the antidepressant effect of sertraline by concurrent treatment with liothyronine without a significant increase in adverse effects. The antidepressant effect of liothyronine may be directly linked to thyroid function.

Comparative bioavailability of different formulations of levothyroxine and liothyronine in healthy volunteers. [2006.12]
OBJECTIVE: To evaluate the relative bioavailability of T4 sodium and liothyronine sodium (T3), administered in single doses as oral solution (drops) and tablet forms, according to two separate study protocols... CONCLUSIONS: The bioavailability of the two oral solutions (T4-Ibsa and T3-Ibsa oral solutions) and the corresponding tablet forms (Eutirox 100 and Ti-tre tablets) were confirmed and they can be considered bioequivalent and therapeutically interchangeable.

Substitution of liothyronine at a 1:5 ratio for a portion of levothyroxine: effect on fatigue, symptoms of depression, and working memory versus treatment with levothyroxine alone. [2005.07]
OBJECTIVE: To attempt to confirm a previous report of superior effectiveness of using two thyroid hormones rather than one hormone to treat hypothyroidism... CONCLUSION: With regard to the outcomes measured, substitution of LT(3) at a 1:5 ratio for a portion of baseline LT(4) yielded no better results than did treatment with the original dose of LT(4) alone.

Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial. [2005.05]
Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5:1 or 10:1 with LT4 monotherapy... Decrease in body weight was associated with satisfaction with study medication.

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