Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)
REMEDYREPACK INC.
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM 0.075 mg
PRESCRIPTION DRUG
New Drug Application
LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM TABLET REMEDYREPACK INC. ---------- LEVOTHYROXINE SODIUM TABLETS, USP DESCRIPTION Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T ) sodium]. Synthetic T is identical to that produced in the human thyroid gland. Levothyroxine (T ) sodium has an empirical formula of C H I N NaO • H O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate. The following are the coloring additives per tablet strength: STRENGTH (MCG) COLOR ADDITIVE(S) 25 FD&C Yellow No. 6 Aluminum Lake 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 112 D&C Red No. 27 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 Aluminum Lake 200 FD&C Red No. 40 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake CLINICAL PHARMACOLOGY Thyroid hormone synthesis and secretion is regulated by the hypothalamic-pituitary-thyroid axis. Thyrotropin-releasing hormone (TRH) released from the hypothalamus stimulates secretion of thyrotropin-stimulating hormone, TSH, from the anterior pituitary. TSH, in turn, is the physiologic stimulus for the synthesis and secretion of thyroid hormones, L-thyroxine (T ) and L-triiodothyronine (T ), by the thyroid gland. Circulating serum T and T levels exert a feedback effect on both TRH and 4 4 4 15 10 4 4 2 4 3 3 4 TSH secretion. When serum T and T levels increase, TRH and TSH secretion decrease. When thyroid hormone levels decrease, TR Прочитать полный документ