LEVOTHYROXINE SODIUM- levothyroxine sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

LEVOTHYROXINE SODIUM

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 150 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 mana

Product summary:

Levothyroxine sodium tablets, USP are supplied as scored, color coded potency marked tablets as follows: 150 mcg, capsule shape tablets, blue color, on one side debossed with "150"; on the other side bisected and debossed with "GG" to the left of the bisect and "338" to the right: Bottles of 30 NDC 68071-3021-3 Bottles of 60 NDC 68071-3021-6 Bottles of 90 NDC 68071-3021-9

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
LEVOTHYROXINE SODIUM TABLETS, USP
LEVOTHYROXINE SODIUM TABLETS, USP
RX ONLY
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
4
4
4
15
10
4
4
2
200
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
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 ex