LEVOTHYROXINE SODIUM tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Northwind Pharmaceuticals, LLC

INN (שם בינלאומי):

LEVOTHYROXINE SODIUM

הרכב:

LEVOTHYROXINE SODIUM ANHYDROUS 0.137 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

מצב אישור:

New Drug Application

מאפייני מוצר

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
NORTHWIND PHARMACEUTICALS, LLC
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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, FD&C Blue No. 1 Aluminum 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 control of DNA
transcription and protein synthesis. T3 and T4