Levothyroxine sodium is used for the following indications: Please click here for full Prescribing Information, including Boxed Warning. Hypothyroidism: As a
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), and 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 effects of surgery, radiation, or drugs, with or without the presence of goiter.
Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of
any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since
thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids. TIROSINT is contraindicated in patients
with hypersensitivity to any of the inactive ingredients in TIROSINT capsules. TIROSINT is also contraindicated for anyone who may be unable to swallow a
capsule (e.g., infants, small children).
In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine
sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis. If the serum TSH level is
not suppressed, TIROSINT should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and
clinical monitoring for potential associated adverse cardiovascular signs and symptoms of hyperthyroidism.
Effects on bone mineral density – In women, long term levothyroxine sodium therapy has been associated with increased bone resorption, thereby
decreasing bone mineral density, especially in post-menopausal women on greater than replacement doses or in women who are receiving suppressive
doses of levothyroxine sodium. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and
phosphorous, elevations in bone alkaline phosphatase and suppressed serum parathyroid hormone levels. Therefore, it is recommended that patients
receiving levothyroxine sodium be given the minimum dose necessary to achieve the desired clinical and biochemical response.
Patients with underlying cardiovascular disease – Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the
elderly in whom there is an increased risk of occult cardiac disease. In these patients, levothyroxine therapy should be initiated at lower doses than those
recommended in younger individuals or in patients without cardiac disease and it should be noted that unlike levothyroxine sodium tablets, TIROSINT
capsules cannot be cut in half. If cardiac symptoms develop or worsen, the levothyroxine dose should be reduced or withheld for one week and then
cautiously restarted at a lower dose. Overtreatment with levothyroxine sodium may have adverse cardiovascular effects such as an increase in heart rate,
cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias. Patients with coronary artery disease who are receiving
levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in
those treated with levothyroxine. Concomitant administration of levothyroxine and sympathomimetic agents to patients with coronary artery disease may
precipitate coronary insufficiency.
Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage such as fatigue, increased
appetite, weight loss, heat intolerance, fever, excessive sweating, and other adverse reactions. This is not an exhaustive list. Please refer to TIROSINT’s full
Prescribing Information for a more comprehensive list of adverse reactions associated with hyperthyroidism.
