LEVOTHYROXINE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOTHYROXINE SODIUM ANHYDROUS (UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Available from:

Unit Dose Services

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Iymphocytic 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.

Product summary:

NDC:50436-5503-1 in a BOTTLE of 30 TABLETS NDC:50436-5503-2 in a BOTTLE of 90 TABLETS

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
UNIT DOSE SERVICES
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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 TSH
secretion. When serum T and T levels increase, TRH and TSH secretion
decrease. When thyroid
4441510442
hormone levels decrea