Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4), LIOTHYRONINE (UNII: 06LU7C9H1V) (LIOTHYRONINE - UNII:06LU7C9H1V)
Asclemed USA, Inc.
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) 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, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer. CONTRAINDICATIONS: Thyroid hormone preparations are generally
HOW SUPPLIED: NP Thyroid® tablets 90 mg (1 1/2 gr) (thyroid tablets, USP) are supplied as follows: Bottles of 30: NDC 76420-569-30 (repackaged from NDC 42192-331-01) Bottles of 60: NDC 76420-569-60 (repackaged from NDC 42192-331-01) Bottles of 90: NDC 76420-569-90 (repackaged from NDC 42192-331-01) Bottles of 100: NDC 76420-569-01 (relabeled from NDC 42192-331-01) NP Thyroid® tablets are tan, round tablets, debossed on one side with “AP” and a 3-digit code on the other side as follows: 90 mg (1 1/2 grain) – “331”
unapproved drug other
NP THYROID 90- LEVOTHYROXINE, LIOTHYRONINE TABLET ASCLEMED USA, INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- NP THYROID 90 NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten- containing grain (wheat, barley, rye). CLINICAL PHARMACOLOGY: The steps in the synthesis of the thyroid hormones are controlled by thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone’s secretion is in turn controlled by a feedback mechanism effected by the thyroid hormones themselves and by thyrotropin releasing hormone (TRH), a tripeptide of hypothalamic origin. Endogenous thyroid hormone secretion is suppressed when exogenous thyroid hormones are administered to euthyroid individuals in excess of the normal gland’s secretion. The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system. The normal thyroid gland contains approximately 200 mcg of levothyroxine (T4) per gram of gland, and 15 mcg of liothyronine (T3) per gram. The ratio of these two hormones in the circulation does not represent the ratio in the thyroid gland, since about 80 percent of peripheral triiodothyronine comes from monodeiodination of levo Przeczytaj cały dokument