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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

LEVOTHYROXINE SODIUM

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 25 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 managem

Product summary:

Levothyroxine sodium tablets, USP are supplied as scored, color coded potency marked tablets as follows: 25 mcg, capsule shape tablets, orange color, on one side debossed with "25"; on the other side bisected and debossed with "GG" to the left of the bisect and "331" to the right: Bottles of 30    NDC: 35356-933-30 50 mcg, capsule shape tablets, white color, on one side debossed with "50"; on the other side bisected and debossed with "GG" to the left of the bisect and "332" to the right: 75 mcg, capsule shape tablets, violet color, on one side debossed with "75"; on the other side bisected and debossed with "GG" to the left of the bisect and "333" to the right: 88 mcg, capsule shape tablets, olive green color, on one side debossed with "88"; on the other side bisected and debossed with "GG" to the left of the bisect and "334" to the right: Bottles of 30    NDC: 35356-955-30 Bottles of 60    NDC: 35356-955-60 Bottles of 90    NDC: 35356-955-90 100 mcg, capsule shape tablets, yellow color, on one side debossed with "100"; on the other side bisected and debossed with "GG" to the left of the bisect and "335" to the right: 112 mcg, capsule shape tablets, rose color, on one side debossed with "112"; on the other side bisected and debossed with "GG" to the left of the bisect and "336" to the right: Bottles of 30    NDC: 35356-924-30 125 mcg, capsule shape tablets, brown color, on one side debossed with "125"; on the other side bisected and debossed with "GG" to the left of the bisect and "337" to the right: 137 mcg, capsule shape tablets, turquoise color, on one side debossed with "137"; on the other side bisected and debossed with "GG" to the left of the bisect and "330" to the right: 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: 175 mcg, capsule shape tablets, lilac color, on one side debossed with "175"; on the other side bisected and debossed with "GG" to the left of the bisect and "339" to the right: 200 mcg, capsule shape tablets, pink color, on one side debossed with "200"; on the other side bisected and debossed with "GG" to the left of the bisect and "340" to the right: 300 mcg, capsule shape tablets, green color, on one side debossed with "300"; on the other side bisected and debossed with "GG" to the left of the bisect and "341" to the right:

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
D&C Red No. 27 Aluminum Lake
4
4
4
15
10 4
4
2
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