LEVOTHYROXINE SODIUM tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Clinical Solutions Wholesale, LLC

ИНН (Международная Имя):

LEVOTHYROXINE SODIUM

состав:

LEVOTHYROXINE SODIUM ANHYDROUS 0.05 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application

Характеристики продукта

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
LEVOTHYROXINE SODIUM TABLETS, USP
DESCRIPTION
Levothyroxine Sodium Tablets, USP contain synthetic crystalline
L-3,3',5,5'-tetraiodothyronine sodium
salt [levothyroxine (T
) sodium]. Synthetic T
is identical to that produced in the human thyroid gland.
Levothyroxine (T
) sodium has an empirical formula of C
H
I
N NaO
• H
O, molecular weight
of 798.86 g/mol (anhydrous), and structural formula as shown:
INACTIVE INGREDIENTS
Colloidal silicon dioxide, lactose, magnesium stearate,
microcrystalline cellulose, corn starch, acacia
and sodium starch glycolate. The following are the coloring additives
per tablet strength:
STRENGTH (MCG)
COLOR ADDITIVE(S)
25
FD&C Yellow No. 6 Aluminum Lake
50
None
75
FD&C Red No. 40 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake
88
D&C Yellow No. 10 Aluminum Lake,
FD&C Yellow No. 6 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake
100
D&C Yellow No. 10 Aluminum Lake,
FD&C Yellow No. 6 Aluminum Lake
112
D&C Red No. 27 Aluminum Lake
125
FD&C Yellow No. 6 Aluminum Lake,
FD&C Red No. 40 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake
137
FD&C Blue No. 1 Aluminum Lake
150
FD&C Blue No. 2 Aluminum Lake
175
FD&C Blue No. 1 Aluminum Lake, D&C
Red No. 27 Aluminum Lake
200
FD&C Red No. 40 Aluminum Lake
300
D&C Yellow No. 10 Aluminum Lake,
FD&C Yellow No. 6 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake
CLINICAL PHARMACOLOGY
Thyroid hormone synthesis and secretion is regulated by the
hypothalamic-pituitary-thyroid axis.
4
4
4
15
10
4
4
2
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 (T
) and L-triiodothyronine
(T
), by the thyroid gland. Circulating serum T
and T
levels exert a feedback effect on both TRH
and TSH secretion. When serum T
and T
levels increase, TRH and TSH secretion decrease. When
thyroid