Welcome to our Clinical Insights page.
Clinical Practice Guidelines for Hypothyroidism in Adults:
Co-sponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association
The American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on Hypothyroidism in Adults reports that, "Treatment of hypothyroidism is best accomplished using synthetic T4 sodium preparations. Because of the uniqueness of the various tablet formulations and a recently introduced preparation of liquid containing capsules with the inactive ingredients gelatin, glycerin, and water, and because of uncertainty about the sensitivity of current bioequivalence assessment procedures to assure true interchangability among the tablets, current recommendations encourage the use of a consistent T4 preparation for individual patients to minimize variability from refill to refill."
"Some reports have indicated an apparent increased dosage requirement for T4 in some patients with diminished gastric acid secretion. This has led to in-vitro work showing significant differences in dissolution among T4 preparations, profiles of which appear to be dependent on the pH of the solution in which the preparations were dissolved. The liquicap preparation (Tirosint®) dissolution profile was the least affected by changes in pH."
Download the full Guidelines at http://aace.metapress.com/content/
Clinical Insights on T4 Therapy in a Liquid Gel Cap Form:
Could It Change Outcomes?
Here you can view a series of podcasts about Tirosint®, a unique, liquid gel cap formulation of levothyroxine for the treatment of hypothyroidism.
The podcasts feature presentations by noted endocrinologist Dr. Burton V. Caldwell.
You can also access a white paper, slide presentation, and a clinical reprint of the dissolution study by Pabla et al, discussed by Dr. Caldwell in his podcast presentation.
Click here to view reprint:
Dissolution study by Pabla et al
for Purity, Consistency, and Stability
Click here to view Part 1:
PC - Download wmv Mac - Download mp4
"pH Effect"
Click here to view Part 2:
PC - Download wmv Mac - Download mp4
A noted clinical endocrinologist, Dr. Caldwell served on the faculty of Yale University as Associate Professor of Medicine from 1970 to 1980 and Attending Associate Professor of Medicine from 1980 to 2005. Dr. Caldwell was also a senior scientist at the Worcester Foundation from 1965 to 1970. He is the recipient of the National Science Foundation Award and the Career Development Award from the National Institutes of Health.
Reference: 1. Data on file, 2006, Akrimax Pharmaceuticals, LLC.
Levothyroxine sodium is used for the following indications: Please click here for full Prescribing Information, including Boxed Warning.
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), 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.
WARNING: Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
CONTRAINDICATIONS
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 (eg, infants, small children).
WARNINGS
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.
PRECAUTIONS
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
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.
Please click here for full Prescribing Information, including Boxed Warning.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).
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Manufactured for Akrimax Pharmaceuticals, LLC by: IBSA Institut Biochimique SA, 6903 Lugano, Switzerland
Tirosint and the “T” symbol are registered trademarks of IBSA Institut Biochimique SA, licensed to Akrimax Pharmaceuticals, LLC.
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Revised March 23, 2013.
