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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

LEVOTHYROXINE SODIUM

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 100 ug

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. 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 management of thyrotropin-dependent well differentiated thyroid

Product summary:

Levothyroxine Sodium Tablets, USP 100mcg are available as yellow capsule-shaped tablets that are debossed with an M on one side of the tablet. The other side of each tablet is debossed with an L to the left of the score and an 8 to the right of the score. Bottle of 30 - 68788-9293-3 Bottle of 90 - 68788-9293-9 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. U.S. Patent No. 6,645,526 U.S. Patent No. 6,936,274 U.S. Patent No. 7,052,717 U.S. Patent No. 7,195,779 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2008 LVTX:R11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
PREFERRED PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 3BB082C5-DB5C-4D32-8FC8-52C09F31081B
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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 a molecular formula of C
H I N NaO * H O, molecular weight of
798.86 g/mol (anhydrous), and structural formula as shown:
INACTIVE INGREDIENTS
Levothyroxine sodium tablets, USP, for oral administration, are
available containing 25 mcg, 50 mcg, 75
mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200
mcg or 300 mcg of
levothyroxine sodium, USP. In addition, each tablet contains the
following inactive ingredients:
butylated hydroxyanisole, colloidal silicon dioxide, crospovidone,
magnesium stearate, mannitol,
microcrystalline cellulose, povidone, sodium lauryl sulfate and
sucrose. The following are the
coloring 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, FD&C Red No. 40 Aluminum Lake
88
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C
Yellow No. 6 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, D&C Red No. 30 Aluminum Lake
125
FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C
Yellow
No. 6 Aluminum Lake
137
FD&C Blue No. 2 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
FD&C Red No. 40 Aluminum Lake
300
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C
Yellow No. 6 Aluminum Lake
CLINICAL PHARMACOLOGY
Thyroid hormone synthesis and secretion is regulated by the
hypothalamic-pituitary-thyroid axis.
4
4
4
15
10 4
4
2
Thyrotropin-releasing hormone (TRH) released from the hypothalamus
stimulates