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:

Cardinal Health 107, LLC

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 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 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 (5.3)] . Experience with levothyroxine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages [see Data]. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TS

Product summary:

Levothyroxine Sodium Tablets, USP are available containing 25 mcg, 50 mcg, 75 mcg, 100 mcg, 125 mcg or 150 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. Overbagged with 10 tablets per bag, NDC 55154-5362-0 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. Overbagged with 10 tablets per bag, NDC 55154-5380-0 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. Overbagged with 10 tablets per bag, NDC 55154-5395-0 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. Overbagged with 10 tablets per bag, NDC 55154-5381-0 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. Overbagged with 10 tablets per bag, NDC 55154-4376-0 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. Overbagged with 10 tablets per bag, NDC 55154-4377-0 Storage Conditions:   Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
CARDINAL HEALTH 107, LLC
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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_
•
•
INDICATIONS AND USAGE
Levothyroxine sodium tablets are levothyroxine sodium (T4) indicated
for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300
mcg ( 3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
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)
Limitations of Use:
•
•
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 drugs that are known to
interfere with absorption. ( 2.1)
Evaluate the need for dose adjustments when regularly administering
within one hour of certain foods
that may affect absorption. ( 2.1)
Starting dose depends on a va