LEVOTHYROXINE SODIUM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Disponible desde:

NuCare Pharmaceuticals,Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

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