LEVOTHYROXINE SODIUM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Direct_Rx

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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” 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.

Status otorisasi:

New Drug Application

Karakteristik produk

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