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:

TYA Pharmaceuticals

INN (שם בינלאומי):

LEVOTHYROXINE SODIUM

הרכב:

LEVOTHYROXINE SODIUM ANHYDROUS 50 ug

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Levothyroxine sodium is used for the following indications: – 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. Hypothyroidism – In the treatment or prevention of various types of euthyroid goiters (see and  ), including thyroid nodules (see and  ), subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter (see  and  ) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

leaflet_short:

NDC:64725-5181-1 in a BOTTLE of 100 TABLETS

מצב אישור:

New Drug Application

מאפייני מוצר

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
TYA PHARMACEUTICALS
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LEVOTHYROXINE SODIUM TABLETS, USP
DESCRIPTION
Levothyroxine sodium tablets, USP contains 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 x H
O, molecular weight of
798.86 g/mol (anhydrous), and structural formula as shown:
INACTIVE INGREDIENTS
Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal
Silicone Dioxide, NF; Sodium
Starch Glycolate, NF. The following are the color additives by tablet
strength:
STRENGTH (MCG)
COLOR ADDITIVE(S)
25
FD&C Yellow No. 6 Aluminum Lake
50
None
75
FD&C Blue No. 2 Aluminum Lake D&C Red No. 27 Aluminum Lake
88
FD&C Blue No. 1 Aluminum Lake D&C Yellow No. 10 Aluminum Lake
D&C Red No. 30 Aluminum Lake
100
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)
112
D&C Red No. 27 Aluminum Lake D&C Red No. 30 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
D&C Red No. 27 Aluminum Lake D&C Red No. 30 Aluminum Lake FD&C
Blue No. 1 Aluminum Lake
200
D&C Yellow No. 10 Aluminum Lake D&C Red No. 27 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.
Thyrotropin-releasing hormone (TRH) released from the hypothalamus
stimulates secretion of
44
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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 ser