LEVOTHYROXINE SODIUM tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Dostępny od:

Mylan Institutional Inc.

INN (International Nazwa):

LEVOTHYROXINE SODIUM

Skład:

LEVOTHYROXINE SODIUM ANHYDROUS 88 ug

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 are contraindicated in patients with uncorrected adrenal insufficie

Podsumowanie produktu:

Levothyroxine Sodium Tablets, USP are available containing 88 mcg, 112 mcg, 137 mcg or 175 mcg of levothyroxine sodium, USP. They are available as follows: 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 42292-038-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 42292-039-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 42292-041-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 42292-040-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Storage Conditions:   Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
MYLAN INSTITUTIONAL 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 are levothyroxine sodium (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.
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 prescribing information for do