Tirosint-SOL FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 3, 2024.
FDA Approved: Yes (First approved December 15, 2016)
Brand name: Tirosint-SOL
Generic name: levothyroxine sodium
Dosage form: Oral Solution
Company: IBSA Pharma Inc.
Treatment for: Underactive Thyroid, TSH Suppression
Tirosint-SOL is an oral liquid formulation of levothyroxine (T4) for the treatment of hypothyroidism and for pituitary thyrotropin (thyroid stimulating hormone, TSH) suppression.
- Tirosint-SOL is indicated adult and pediatric patients, including neonates, for:
- Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
- Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
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.
- Levothyroxine sodium is approved in oral tablet, oral solution, and intravenous injection dosage forms under multiple brand names.
- The current labeling for levothyroxine sodium therapies instructs patients to self-administer the drug once daily, on an empty stomach, one-half to one hour before breakfast.
The Tirosint-SOL label indicates that it can be administered 15 minutes before eating breakfast.
- The absorption and efficacy of levothyroxine tablets has been shown to be affected by the concomitant use of proton pump inhibitors (PPIs).
The Tirosint-SOL label does not include an interaction with PPIs. - Tirosint-SOL is administered once daily, on an empty stomach, 15 minutes before breakfast.
- 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.
Development timeline for Tirosint-SOL
Further information
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