LEVOTHYROXINE SODIUM tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

TYA Pharmaceuticals

INN (Kansainvälinen yleisnimi):

LEVOTHYROXINE SODIUM

Koostumus:

LEVOTHYROXINE SODIUM ANHYDROUS 50 ug

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

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
41510442
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