LEVOTHYROXINE SODIUM- levothyroxine sodium tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Preferred Pharmaceuticals Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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, TSH should be monitored and levothyroxine sodium tablets dosage adjusted during pregnancy [see Cli

Product samenvatting:

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 68788-7227-3 bottles of 30 tablets NDC 68788-7227-6 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
PREFERRED 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_
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INDICATIONS AND USAGE
Levothyroxine sodium tablets are levothyroxine sodium (T4) indicated
for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300
mcg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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:
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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 depen