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SYNTHROID (levothyroxine sodium tablets) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is the related to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 - H2O, and molecular weight of 798.86 g/mol.
This drug is also indicated for Hypothyroidism- As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, and drugs, with or without the presence of goiter. Pituitary TSH Suppression- In the treatment or prevention of various types of euthyroid goiters), including thyroid nodules subacute or chronic lymphocytic thyroiditis and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state and the goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of SYNTHROID that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, body weight,concomitant medications, and the specific nature of the condition being treated). Hence, the following recommendations serve only as dosing guidelines for patient’s safety. Dosing must be individualized and adjustments made based on periodic assessment of the medical history, patient's clinical response and laboratory parameters.
SYNTHROID is administered as a single daily dose, preferably one-half to one-hour before meal in the morning. SYNTHROID should be taken at least 4 hours apart from drugs that are known to interfere with its absorption of the drug.