País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)
Preferred Pharmaceuticals, Inc.
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM ANHYDROUS 100 ug
ORAL
PRESCRIPTION DRUG
Levothyroxine sodium is used for the following indications: As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid
Levothyroxine Sodium Tablets, USP 100mcg are available as yellow capsule-shaped tablets that are debossed with an M on one side of the tablet. The other side of each tablet is debossed with an L to the left of the score and an 8 to the right of the score. Bottle of 30 - 68788-9293-3 Bottle of 90 - 68788-9293-9 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. U.S. Patent No. 6,645,526 U.S. Patent No. 6,936,274 U.S. Patent No. 7,052,717 U.S. Patent No. 7,195,779 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2008 LVTX:R11
Abbreviated New Drug Application
LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET PREFERRED PHARMACEUTICALS, INC. REFERENCE LABEL SET ID: 3BB082C5-DB5C-4D32-8FC8-52C09F31081B ---------- 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 a molecular formula of C H I N NaO * H O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: INACTIVE INGREDIENTS Levothyroxine sodium tablets, USP, for oral administration, are available containing 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of levothyroxine sodium, USP. In addition, each tablet contains the following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate and sucrose. The following are the coloring additives by tablet strength: STRENGTH (MCG) COLOR ADDITIVE(S) 25 FD&C Yellow No. 6 Aluminum Lake 50 None 75 FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake 88 D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 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, D&C Red No. 30 Aluminum Lake 125 FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 137 FD&C Blue No. 2 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 200 FD&C Red No. 40 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake CLINICAL PHARMACOLOGY Thyroid hormone synthesis and secretion is regulated by the hypothalamic-pituitary-thyroid axis. 4 4 4 15 10 4 4 2 Thyrotropin-releasing hormone (TRH) released from the hypothalamus stimulates Llegiu el document complet