LEVOTHYROXINE SODIUM tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Northwind Pharmaceuticals

INN (International Nazwa):

LEVOTHYROXINE SODIUM

Skład:

LEVOTHYROXINE SODIUM ANHYDROUS 0.1 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Levothyroxine sodium is used for the following indications: Hypothyroidism – 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. Pituitary TSH Suppression – 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 thyr

Status autoryzacji:

New Drug Application

Charakterystyka produktu

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
NORTHWIND PHARMACEUTICALS
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LEVOTHYROXINE SODIUM
BOXED WARNING
WARNING:
Thyroid hormones, including Levothyroxine sodium tablets, USP, 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.
DESCRIPTION
Levothyroxine sodium tablets, USP contains synthetic crystalline
L-3,3’,5,5’-tetraiodothyronine sodium
salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that
produced in the human thyroid gland.
Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 x
H2O, molecular weight
of 798.86 g/mol (anhydrous).
Inactive Ingredients
Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal
Silicone Dioxide, NF; Sodium
Starch Glycolate, NF, D&C Yellow No. 10 Aluminum Lake
D&C Red Lake Blend (D&C Red No. 27 Lake and D&C Red No. 30 Lake).
CLINICAL PHARMACOLOGY
Thyroid hormone synthesis and secretion is regulated by the
hypothalamic-pituitary-thyroid axis.
Thyrotropin-releasing hormone (TRH) released from the hypothalamus
stimulates secretion of
thyrotropin-stimulating hormone, TSH, from the anterior pituitary.
TSH, in turn, is the physiologic
stimulus for the synthesis and secretion of thyroid hormones,
L-thyroxine (T4) and L-triiodothyronine
(T3), by the thyroid gland. Circulating serum T3 and T4 levels exert a
feedback effect on both TRH and
TSH secretion. When serum T3 and T4 levels increase, TRH and TSH
secretion decrease. When
thyroid hormone levels decrease, TRH and TSH secretion increase.
The mechanisms by which thyroid hormones exert their physiologic
actions are not completely
understood, but it is thought that their principal effects are exerted
through