LEVOTHYROXINE SODIUM tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Direct_Rx

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 and Precautio

Огляд продуктів:

Levothyroxine Sodium Tablets, USP are supplied as follows: Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 25 Orange/Caplet “25” and “GG/331” 50 White/ Caplet “50” and “GG/332” 75 Violet/ Caplet “75” and “GG/333” 88 Olive Green/ Caplet “88” and ‘GG/334” 100 Yellow/ Caplet “100” and “GG/335” 112 Rose/ Caplet “112” and “GG/336” 125 Brown/ Caplet “125” and “GG/337” 137 Turquoise/ Caplet “137” and “GG/330” 150 Blue/ Caplet “150” and “GG/338” 175 Lilac/ Caplet “175” and “GG/339” 200 Pink/ Caplet “200” and “GG/340” 300 Green/ Caplet “300” and “GG/341” 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.

Статус Авторизація:

New Drug Application

Характеристики продукта

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
DIRECT_RX
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LEVOTHYROXINE SODIUM
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including levothyroxine sodium tablets, either alone
or with
other therapeutic agents, should not be used for the treatment of
obesity or for
weight loss.
In euthyroid patients, doses within the range of daily hormonal
requirements are
ineffective for weight reduction.
Larger doses may produce serious or even life threatening
manifestations of
toxicity, particularly when given in association with sympathomimetic
amines such
as those used for their anorectic effects [see Adverse Reactions (6),
Drug
Interactions (7.7) and Overdosage (10)].
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.
2.1 General Administration Information
Take levothyroxine sodium tablets with a full glass of water as the
tablet may rapidly
disintegrate.
Administer levothyroxine sodium tablets as a single daily dose, on an
empty stomach,
one-half to one hour before breakfast.
Administer levothyroxine sodium tablets at least 4 hours before or
after drugs known to
interfere with levothyroxine sodium tablets absorption [see Drug
Interactions (7.1)].
Evaluat