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Signs & Symptoms

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Symptoms you should never ignore if you suspect your thyroid function might be compromised

January 25, 2019 Signs & Symptoms

When should you seek medical advice? Hypothyroidism, while common, can disguise itself under a variety of symptoms that appear to be everyday aches, pains and discomfort. As a result, many people who suffer from low levels of thyroid hormones will proceed with life, dismissing a combination of symptoms that are actually indicators of a serious Read More »

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IBSA Pharma Inc., 8 Campus Drive, Suite 201, Parsippany, NJ 07054

Manufactured by: IBSA Institut Biochimique SA, 6903 Lugano, Switzerland Tirosint and the "T" symbol are registered trademarks of IBSA Institut Biochimique SA, licensed to IBSA Pharma Inc.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 (1-800-332-1088). © 2019 IBSA Pharma Inc. All Rights Reserved. © 2023 Tirosint®-SOL, all rights reserved.

References
  1. American Thyroid Association. Hypothyroidism: A Booklet for Patients and Their Families. https://www.thyroid.org/wp-content/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf. Accessed March 27, 2019.
  2. ATA/AACE Taskforce on Hypothyroidism in Adults. Clinical Practice Guidelines for Hypothyroidism in Adults: Cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocrine Pract. 2012;18(6):988-1028.
  3. Tirosint [package insert]. Lugano, Switzerand: Institut Biochimique SA (IBSA); 2018.
  4. Ernst FR, Sandulli W, Elmor R, Welstead J, Sterman AB, Lavan MK. Retrospective study of patients switched from tablet formulations to a gel cap formulation of levothyroxine: results of the CONTROL Switch Study. Drugs in R&D. 2017;17:103-115.
  5. Ruchala M, Szczepanek-Parulska E, Zybek A. The influence of lactose intolerance and other gastro-intestinal tract disorders on L-thyroxine absorption. Polish J Endocrinology. 2012;63(4):318-323.
  6. McMillan M, Rotenberg KS, Vora K, et al. Comorbidities, concomitant medications, and diet as factors affecting levothyroxine therapy; results of the CONTROL Surveillance Project. Drugs in R&D. 2015;16(1):53-68.
  7. Data on file, Institut Biochimique SA (IBSA).
  8. Synthroid [package insert]. North Chicago, IL: AbbVie Inc; 2018.
  9. Pabla D, Akhlanghi F, Hossein Z. A comparative pH-dissolution profile study of selected commercial levothyroxine products using inductively coupled plasma mass spectrometry. Eur J Pharm Biopharm. 2009;72:105-110.
  10. Seng Yue S, Benvenga S, Scarsi C, Loprete L, Ducharme MP. When bioequivalence in healthy volunteers may not translate to bioequivalence in patients: differential effects of increased gastric pH on the pharmacokinetics of levothyroxine capsules and tablets. J Pharm Pharm Sci. 2015;18(5):844-855.
  11. Kennedy J. Herb and supplement use in the US adult population. Clin Ther. 2005;27(11):1847-1858.
  12. Tirosint-SOL [package insert]. Lugano, Switzerland: Institut Biochimique SA (IBSA); 2018.
  13. US Department of Health and Human Services/Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. 39th ed. https://www.fda.gov/media/71474/download Accessed May 22, 2019.
  14. Based on RelayHealth eVoucherRx™ Network pharmacy paid claims from April 2018–March 2019.
Common Excipients
  1. Modified wheat starch (gluten)
  2. Lactose monohydrate
  3. Dyes
  4. Confectioners’ sugar (contains corn starch)
  5. Microcrystaline cellulose
  6. Butylated hydroxyanisole (BHA)
  7. Talc
  8. Croscarmellose sodium
  9. Calcium phosphate dibasic
  10. Colloidal silicon dioxide
  11. Mannitol
  12. Crospovidone
  13. Magnesium stearate
  14. Acacia
  15. Sucrose
  16. Povidone
  17. Sodium lauryl sulfate
ingredient-chart
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Tirosint-SOL Important Safety Information



IMPORTANT SAFETY INFORMATION for TIROSINT-SOL (levothyroxine sodium) ORAL SOLUTION

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including TIROSINT-SOL, 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 

  • Hypersensitivity to glycerol
  • Uncorrected adrenal insufficiency

Warnings and Precautions 

  • Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation
  • Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma
  • Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT-SOL treatment
  • Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism
  • Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy
  • Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose

Limitations of Use 

  • Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
  • Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Adverse Reactions

Adverse reactions associated with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash

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*For Full Prescribing Information, visit www.TirosintSOL.com