LIOTHYRONINE SODIUM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

AvKARE

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Liothyronine Sodium Tablets, USP are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Liothyronine Sodium Tablets, USP are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Liothyronine Sodium Tablets, USP are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - Liothyronine Sodium Tablets, USP 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 Liothyronine Sodium Tablets, USP may induce hyperthyroidism [see Warnings and Precautions (5.4)]. - Liothyronine Sodium Tablets, USP are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Liothyronine Sodium Tablets, USP are 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-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 liothyronine sodium dosage adjusted during pregnancy (see Clinical Considerations). There are no animal studies conducted with liothyronine during pregnancy. Liothyronine Sodium Tablets, USP should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Disease-associated maternal and/or embryo/fetal risk Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery. Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Dose adjustments during pregnancy and the postpartum period Pregnancy may increase liothyronine sodium requirements. Serum TSH levels should be monitored and the liothyronine sodium dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the liothyronine sodium dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3)] . Human Data Liothyronine is approved for use as a replacement therapy for hypothyroidism. Data from post-marketing studies have not reported increased rates of fetal malformations, miscarriages, or other adverse maternal or fetal outcomes associated with liothyronine use in pregnant women. Risk Summary Limited published studies report that liothyronine is present in human milk. However, there is insufficient information to determine the effects of liothyronine on the breastfed infant and no available information on the effects of liothyronine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for liothyronine sodium and any potential adverse effects on the breastfed infant from liothyronine sodium or from the underlying maternal condition. The initial dose of Liothyronine Sodium Tablets, USP varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3, 2.4)]. In pediatric patients in whom a diagnosis of permanent hypothyroidism has not been established, discontinue thyroid hormone for a trial period, but only after the child is at least 3 years of age. Obtain serum TSH, T4, and T3 levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted [see Dosage and Administration (2.6)]. Congenital Hypothyroidism  [see Dosage and Administration (2.2, 2.6)] Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate thyroid hormone immediately upon diagnosis. Thyroid hormone is generally continued for life in these patients. Closely monitor infants during the first 2 weeks of thyroid hormone therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. Closely monitor patients to avoid undertreatment or overtreatment. Undertreatment may have deleterious effects on intellectual development and linear growth. Overtreatment is associated with craniosynostosis in infants, may adversely affect the tempo of brain maturation, and may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature [see Dosage and Administration (2.6) and Adverse Reactions (6)]. Acquired Hypothyroidism in Pediatric Patients Closely monitor patients to avoid undertreatment and overtreatment. Undertreatment may result in poor school performance due to impaired concentration and slowed mentation and in reduced adult height. Overtreatment may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature. Treated children may manifest a period of catch-up growth, which may be adequate in some cases to normalize adult height. In children with severe or prolonged hypothyroidism, catch-up growth may not be adequate to normalize adult height [see Adverse Reactions (6)]. Because of the increased prevalence of cardiovascular disease among the elderly, initiate Liothyronine Sodium Tablets, USP at less than the full replacement dose [see Dosage and Administration (2.3) and  Warnings and Precautions (5.1)] . Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with thyroid hormone overtreatment in the elderly.

Resumen del producto:

Liothyronine Sodium Tablets, USP (white to off-white, round, SC) are supplied as follows: 90 count - 42291-417-90 90 count - 42291-418-90 90 count - 42291-419-90 Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 OS020A-00 REV.0918 Store between 15°C and 30°C (59°F and 86°F).

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LIOTHYRONINE SODIUM TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIOTHYRONINE SODIUM
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LIOTHYRONINE
SODIUM TABLETS, USP.
INITIAL U.S. APPROVAL
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THYROID HORMONES, INCLUDING LIOTHYRONINE SODIUM 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
Liothyronine sodium 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 Thyrotropin (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:
- Not indicated for suppression of benign thyroid nodules and nontoxic
diffuse goiter in iodine-sufficient
patients. ( 1)
- Not indicated for treatment of hypothyroidism during the recovery
phase of subacute thyroiditis. ( 1)
DOSAGE AND ADMINISTRATION
Administer Liothyronine Sodium Tablets, USP 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
w