LEVOTHYROXINE SODIUM- levothyroxine sodium tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Bryant Ranch Prepack

DCI (Dénomination commune internationale):

LEVOTHYROXINE SODIUM

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 0.025 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the managem

Descriptif du produit:

Product: 63629-1437 NDC: 63629-1437-1 30 TABLET in a BOTTLE Product: 63629-2727 NDC: 63629-2727-2 100 TABLET in a BOTTLE NDC: 63629-2727-3 90 TABLET in a BOTTLE NDC: 63629-2727-4 60 TABLET in a BOTTLE NDC: 63629-2727-1 30 TABLET in a BOTTLE Product: 63629-4251 NDC: 63629-4251-1 30 TABLET in a BOTTLE NDC: 63629-4251-2 100 TABLET in a BOTTLE NDC: 63629-4251-4 28 TABLET in a BOTTLE NDC: 63629-4251-3 90 TABLET in a BOTTLE Product: 63629-6646 NDC: 63629-6646-1 30 TABLET in a BOTTLE NDC: 63629-6646-2 90 TABLET in a BOTTLE Product: 63629-6890 Product: 63629-7132 NDC: 63629-7132-1 30 TABLET in a BOTTLE

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
BRYANT RANCH PREPACK
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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.
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
4
4
4
15
10 4
4
2
4
3
3
4
TSH secretion. When serum T and T levels increase, TRH and TSH
secretion decrease. When
thyroid horm