LEVOTHYROXINE and LIOTHYRONINE

FDA Drug Profile — EvexiTHROID, RenThyroid

Drug Details

Generic Name
LEVOTHYROXINE and LIOTHYRONINE
Brand Names
EvexiTHROID, RenThyroid
Application Number
Sponsor
Trifluent Pharma, LLC
NDC Codes
16
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
LEVOTHYROXINE, LIOTHYRONINE

Indications and Usage

INDICATIONS AND USAGE RenThyroid (Thyroid Tablets, USP) 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 (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 ). As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.

Warnings

WARNINGS Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.