Drug intelligence / Profile preview

Tirosint-SOL

Development stage
Approved
Lead developer
IBSA
Modality
Drug Delivery Systems
Administration
Oral
01

Overview

Tirosint-SOL is a liquid formulation of levothyroxine sodium, designed for thyroid hormone replacement therapy. It comes in a unique oral solution form that contains only three ingredients: levothyroxine sodium (the active ingredient), glycerol, and water. This makes it particularly suitable for patients with allergies, absorption issues, or those who have difficulty swallowing pills. ## Key Information Tirosint-SOL is FDA-approved for treating hypothyroidism (underactive thyroid) in adults and children, including neonates. It can also be used with surgery and radioiodine therapy to manage thyroid-dependent well-differentiated thyroid cancer. The medication is dispensed in single-dose ampules to protect against moisture and light, preserving its potency. It can be administered either directly into the mouth or mixed with water. ## Administration Tirosint-SOL should be taken: - As a single daily oral dose - On an empty stomach - 15 minutes before breakfast - At least 4 hours before or after drugs known to interfere with its absorption To administer Tirosint-SOL: 1. With water: Squeeze the contents of one ampule into a glass of water, stir, and drink immediately. Rinse the glass with additional water and drink to ensure the total dose is taken. 2. Directly: Either squeeze it into the mouth OR onto a spoon and immediately consume. ## Dosage Information Tirosint-SOL is available in multiple dosage strengths: 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, and 200 mcg/mL. For adults with hypothyroidism, the recommended starting dosage is typically 1.6 mcg/kg/day, though some patients may require a lower starting dose. For elderly patients or those with cardiac conditions, a lower starting dose is recommended to avoid exacerbating cardiac symptoms. Dosage titration is based on serum TSH or free-T4 levels, with adjustments typically made in 12.5 to 25 mcg increments every 4-6 weeks until the patient reaches euthyroid status. ## Advantages Tirosint-SOL offers several advantages over traditional levothyroxine tablets: - Contains only three ingredients (levothyroxine, glycerol, and water) - Free from common allergens like gluten, lactose, dyes, and other inactive ingredients found in tablets - Demonstrates superior absorption - Less affected by food, coffee, or proton pump inhibitors - Suitable for patients with digestive issues - Ideal for those unable to swallow pills or requiring precise dosing Tirosint-SOL was FDA approved on December 15, 2016, and is manufactured by IBSA Pharma Inc.

Brand names
Tirosint-SOL
02

Targets

THRA (Thyroid hormone receptor alpha)THRB (Thyroid hormone receptor beta)THR (Thyroid hormone receptor)

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