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:

Rebel Distributors Corp.

INN (International Name):

Levothyroxine Sodium

Composition:

Levothyroxine 0.025 mg

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

Product summary:

Levothyroxine Sodium Tablets, USP are round, color coded, partial bisected tablets debossed with JSP and ID Number: 0.025 mg tablets; Bottle of 30:      NDC 21695-748-30 0.050 mg tablets; Bottle of 30:      NDC 21695-749-30 Bottle of 90:      NDC 21695-749-90 0.075 mg tablets; Bottle of 30:      NDC 21695-750-30 Bottle of 90:      NDC 21695-750-90 0.100 mg tablets; Bottle of 30:      NDC 21695-752-30 Bottle of 90:      NDC 21695-752-90 Bottle of 100:      NDC 21695-752-00 0.125 mg tablets; Bottle of 100:     NDC 21695-754-00 0.150 mg tablets; Bottle of 30:      NDC 21695-756-30 Bottle of 90:      NDC 21695-756-90 0.200 mg tablets; Bottle of 30:      NDC 21695-758-30 Bottle of 90:      NDC 21695-059-90 20°C to 25°C (68°F to 77°F) with excursions between 15°C to 30°C (59°F to 86°F) Rx only Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM TABLET
REBEL DISTRIBUTORS CORP.
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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