CYTOMEL- liothyronine sodium tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)

Saatavilla:

Pfizer Laboratories Div Pfizer Inc

INN (Kansainvälinen yleisnimi):

LIOTHYRONINE SODIUM

Koostumus:

LIOTHYRONINE 5 ug

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - CYTOMEL is 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 CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4)] . - CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. CYTOMEL is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)] . Risk Summary Experience with liothyronine use in pregnant women, including data from post-ma

Tuoteyhteenveto:

CYTOMEL tablets (round, white to off-white) are supplied as follows: Store between 15°C and 30°C (59°F and 86°F).

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

CYTOMEL- LIOTHYRONINE SODIUM TABLET
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYTOMEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CYTOMEL.
CYTOMEL (LIOTHYRONINE SODIUM) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1956
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THYROID HORMONES, INCLUDING CYTOMEL, 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, 7.7, 10).
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2, 1.3)
12/2018
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)
12/2018
Contraindications (4)
12/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)
12/2018
INDICATIONS AND USAGE
CYTOMEL is an L-triiodothyronine (T3) indicated for:
Hypothyroidism: As replacement in primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) congenital or
acquired hypothyroidism (1.1)
Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct
to surgery and radioiodine therapy in the
management of well-differentiated thyroid cancer (1.2)
Thyroid Suppression Test: As a diagnostic agent in suppression tests
to differentiate suspected mild hyperthyroidism
or thyroid gland autonomy (1.3)
Limitations of Use:
-
-
DOSAGE AND ADMINISTRATION
Administer CYTOMEL orally once daily and individual dosage according
to patient response and laboratory findings
(2.1)
See full prescribing information for recommended dosage for
hypothyroidism (2.2) TSH suppression in well-
differentiated thyroid cancer (2.3) and for thyroid suppression test
(2.4)
When switching a patient to CYTOMEL, discontinue levothyroxine therapy
and initiate CYTOMEL at a low dosage.
Gradually increase the dose according to the patient's response (2.5)
Adequacy of therapy determined with period