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 150 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 not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. • Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine sodium tablets is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precauti

Product summary:

Levothyroxine Sodium Tablets, USP are supplied as follows: 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: NDC 68788-6353-3Bottles of 30’s NDC 68788-6353-9 Bottles of 90’s Storage Conditions Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Levothyroxine sodium tablets should be protected from light and moisture.

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
PREFERRED PHARMACEUTICALS INC.
----------
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_
• 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).
INDICATIONS AND USAGE
Levothyroxine sodium tablets is L-thyroxine (T4) indicated for:
• 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. (1)
DOSAGE AND ADMINISTRATION
• 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 variety of factors, including age, body
weight, cardiovascular status and
concomitant medications. Peak therapeutic effect may not be attained
for 4-6 weeks. (2.2)
• See full