Liothyronine

Liothyronine sodium tablets are 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. …

• Administer liothyronine sodium tablets orally once daily and individual dosage according to patient response and laboratory findings See full prescribing information for recommended dosage for hypothyroidism TSH suppression in well-differentiated thyroid cancer and for thyroid suppression test When switching a patient to liothyronine sodium tablets, discontinue levothyroxine therapy and initiate liothyronine sodium tablets at a low dosage
• Gradually increase the dose according to the patient's response Adequacy of therapy determined with periodic monitoring of TSH and T3 levels as well as clinical status General Principles of Dosing The dose of liothyronine sodium tablets for hypothyroidism or pituitary Thyroid-Stimulating Hormone (TSH) suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration , Warnings and Precautions , and Drug Interactions ]
• Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration ]
• Administer liothyronine sodium tablets orally once daily
• Recommended Dosage for Hypothyroidism
• Adults The recommended starting dosage is 25 mcg orally once daily. …

Tablets (round, flat, white to off-white) available as follows: 5 mcg: debossed "5" over "220" on one side and plain on the other 25 mcg: debossed "25" above the score and "222" below the score on one side and plain on the other 50 mcg: debossed "50" above the score and "223" below the score on one side and plain on the other Tablets: 5 mcg, 25 mcg, 50 mcg ( 3 )

• The initial dose of liothyronine sodium tablets 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 ]
• 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. …

Because of the increased prevalence of cardiovascular disease among the elderly, initiate liothyronine sodium tablets 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.

• Dosing and Administration Instruct patients that liothyronine sodium tablets should only be taken as directed by their healthcare provider
• Instruct patients to notify their healthcare provider should they become pregnant or breastfeeding or are thinking of becoming pregnant, while taking liothyronine sodium tablets
• Important Information Inform patients that the liothyronine in liothyronine sodium tablets are intended to replace a hormone that is normally produced by the thyroid gland
• Generally replacement therapy is to be taken for life
• Inform patients that liothyronine sodium tablets should not be used as a primary or adjunctive therapy in a weight control program. …

• Liothyronine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions ]
• Uncorrected adrenal cortical insufficiency

See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to liothyronine sodium tablets ( 7 ) 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to liothyronine sodium tablets (see Tables 1 – 4). …

Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate liothyronine sodium tablets at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation ( 2.3 , 5.1 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. …

Adverse reactions associated with liothyronine sodium tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) and Overdosage (10) ] . They include the following: General : fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system : headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal : tremors, muscle weakness and cramps Cardiovascular : palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory : dyspnea Gastrointestinal : diarrhea, vom …

8.1 Pregnancy 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. …

The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4) and Adverse Reactions (6) ] . In addition, confusion and disorientation may occur. Cerebral embolism, seizure, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion. Reduce the liothyronine sodium tablets dose or temporarily discontinued if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status. …

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.