LIOTHYRONINE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Biocon Pharma Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Liothyronine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Liothyronine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Liothyronine sodium tablets are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use - Liothyronine 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 liothyronine sodium may induce hyperthyroidism [see Warnings and Precautions (5.4)] . - Liothyronine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Liothyronine sodium tablets 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 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. Clinical Considerations 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)]. Data 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 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 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.

Product summary:

 Liothyronine sodium tablets, USP are supplied as follows: Strength Tablet Markings NDC – bottles of 90 NDC – bottles of 100 NDC – bottles of 1000 5 mcg White to off white, round shaped tablet, debossed “L3” one side and plain on the other side. NDC 70377-114-11 NDC 70377-114-12 NDC 70377-114-13 25 mcg White to off white, round shaped tablet, debossed “L” above the score and “2” below the score on one side and plain on the other side NDC 70377-115-11 NDC 70377-115-12 NDC 70377-115-13 50 mcg White to off white, round shaped tablet, debossed “L” above the score and “1” below the score on one side and plain on the other side NDC 70377-116-11 NDC 70377-116-12 NDC 70377-116-13 Store between 15°C and 30°C (59°F and 86°F). Dispense in a tight container as defined by USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIOTHYRONINE SODIUM- LIOTHYRONINE SODIUM TABLET
BIOCON PHARMA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIOTHYRONINE SODIUM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIOTHYRONINE SODIUM
TABLETS.
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 LIOTHYRONINE 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, 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 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:
- 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 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-differ