国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings
Levothyroxine Sodium Tablets, USP are supplied as follows: Yellow/ Caplet 100 and GG/335 NDC 68071-4999-3 BOTTLES OF 30 Storage Conditions Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Levothyroxine sodium tablets should be protected from light and moisture.
New Drug Application Authorized Generic
LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOTHYROXINE SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2002 WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • THYROID HORMONES, INCLUDING LEVOTHYROXINE SODIUM TABLETS SHOULD NOT BE USED FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS. • DOSES BEYOND THE RANGE OF DAILY HORMONAL REQUIREMENTS MAY PRODUCE SERIOUS OR EVEN LIFE THREATENING MANIFESTATIONS OF TOXICITY (6, 10). INDICATIONS AND USAGE Levothyroxine sodium tablets is L-thyroxine (T4) indicated for: • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1) • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1) DOSAGE AND ADMINISTRATION • Administer once daily, preferably on an empty stomach, one-half to one hour before breakfast. (2.1) • Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1) • Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. (2.1) • Starting dose depends on a variety of factors, including age, body weight, cardiovascular status and concomitant medications. Peak therapeutic effect may not be attained for 4-6 weeks. (2.2) • See full pre 完全なドキュメントを読む