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:

Mylan Pharmaceuticals Inc.

INN (International Name):

LEVOTHYROXINE SODIUM

Composition:

LEVOTHYROXINE SODIUM ANHYDROUS 25 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypothyroidism: Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: Levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.4) ] . The clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated wit

Product summary:

Levothyroxine Sodium Tablets, USP 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. They are available as follows: The 25 mcg tablets are orange, capsule-shaped, scored tablets debossed with L to the left of the score and 4 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1800-77 bottles of 90 tablets NDC 0378-1800-10 bottles of 1000 tablets The 50 mcg tablets are white, capsule-shaped, scored tablets debossed with L to the left of the score and 5 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1803-77 bottles of 90 tablets NDC 0378-1803-10 bottles of 1000 tablets The 75 mcg tablets are violet, capsule-shaped, scored tablets debossed with L to the left of the score and 6 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1805-77 bottles of 90 tablets NDC 0378-1805-10 bottles of 1000 tablets The 88 mcg tablets are olive, capsule-shaped, scored tablets debossed with L to the left of the score and 7 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1807-77 bottles of 90 tablets NDC 0378-1807-10 bottles of 1000 tablets The 100 mcg tablets are yellow, capsule-shaped, scored tablets debossed with L to the left of the score and 8 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1809-77 bottles of 90 tablets NDC 0378-1809-10 bottles of 1000 tablets The 112 mcg tablets are rose, capsule-shaped, scored tablets debossed with L to the left of the score and 9 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1811-77 bottles of 90 tablets NDC 0378-1811-10 bottles of 1000 tablets The 125 mcg tablets are gray, capsule-shaped, scored tablets debossed with L to the left of the score and 10 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1813-77 bottles of 90 tablets NDC 0378-1813-10 bottles of 1000 tablets The 137 mcg tablets are turquoise, capsule-shaped, scored tablets debossed with L to the left of the score and 15 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1823-77 bottles of 90 tablets NDC 0378-1823-10 bottles of 1000 tablets The 150 mcg tablets are blue, capsule-shaped, scored tablets debossed with L to the left of the score and 11 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1815-77 bottles of 90 tablets NDC 0378-1815-10 bottles of 1000 tablets The 175 mcg tablets are lilac, capsule-shaped, scored tablets debossed with L to the left of the score and 12 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1817-77 bottles of 90 tablets NDC 0378-1817-10 bottles of 1000 tablets The 200 mcg tablets are pink, capsule-shaped, scored tablets debossed with L to the left of the score and 13 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1819-77 bottles of 90 tablets NDC 0378-1819-10 bottles of 1000 tablets The 300 mcg tablets are green, capsule-shaped, scored tablets debossed with L to the left of the score and 14 to the right of the score on one side of the tablet and M on the other side. NDC 0378-1821-77 bottles of 90 tablets Storage Conditions:  Store at 20° to 25°C (68° to 77°F). [See USP 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOTHYROXINE SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOTHYROXINE
SODIUM TABLETS.
LEVOTHYROXINE SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
RECENT MAJOR CHANGES
Indications and Usage (1) 8/2022
Dosage and Administration (2.2) 8/2022
Dosage and Administration (2.3) 8/2022
Warnings and Precautions (5.1) 8/2022
Warnings and Precautions (5.4) 8/2022
INDICATIONS AND USAGE
Levothyroxine sodium tablets are a L-thyroxine (T4) indicated in adult
and pediatric patients, including
neonates, for:
•
•
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300
mcg (3)
CONTRAINDICATIONS
•
THYROID HORMONES, INCLUDING LEVOTHYROXINE SODIUM TABLETS SHOULD NOT BE
USED FOR
THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS.
DOSES BEYOND THE RANGE OF DAILY HORMONAL REQUIREMENTS MAY PRODUCE
SERIOUS OR
EVEN LIFE THREATENING MANIFESTATIONS OF TOXICITY (6, 10).
Hypothyroidism: As replacement therapy in primary (thyroidal),
secondary (pituitary), and tertiary
(hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression:
As an adjunct to surgery and
radioiodine therapy in the management of thyrotropin-dependent
well-differentiated thyroid cancer.
(1)
Not indicated for suppression of benign thyroid nodules and nontoxic
diffuse goiter in iodine-sufficient
patients
Not indicated for treatment of hypothyroidism during the recovery
phase of subacute thyroiditis
Administer once daily, preferably on an empty stomach, one-half to one
hour before breakfast. (2.1)
Administer at least 4 hours before or after drug