Tirosint-SOL (levothyroxine sodium oral solution)
Generic name: levothyroxine sodium · Brand names: TIROSINT-SOL
Quick facts
Rx or otc
Rx (DailyMed: HUMAN PRESCRIPTION DRUG LABEL)
Controlled schedule
None (DailyMed DEA Schedule: None)
Forms and strengths
- Oral solution, 1 mL unit-dose ampule: 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200 mcg/mL (label section 3 and 11)
Common use one line
Replacement therapy for low thyroid hormone (hypothyroidism) and an add-on in thyroid cancer care (label section 1).
What it is used for
Tirosint-SOL is used in adults and children, including newborns, to replace thyroid hormone when the thyroid, pituitary or hypothalamus does not make enough. It is also used with surgery and radioiodine therapy for a type of thyroid cancer. It is not for benign thyroid nodules, nontoxic diffuse goiter, or short-term low thyroid during recovery from subacute thyroiditis.
Section
1 INDICATION AND USAGE
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Hypothyroidism: TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Tirosint-SOL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with TIROSINT-SOL may induce hyperthyroidism. Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
How it works
Thyroid hormones work inside cells by switching genes on so the body makes the proteins it needs. Most of the active hormone, T3 (about 80%), is made from T4 in the body's tissues.
Section
12.1 Mechanism of Action
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.
Dosage: adults
Take it once a day on an empty stomach, 15 minutes before breakfast, and at least 4 hours before or after drugs that interfere with absorption. The label's full replacement dose for adults is 1.6 mcg/kg/day, and some people need a lower start. The dose is changed by 12.5 to 25 mcg every 4 to 6 weeks. People at risk for atrial fibrillation, with heart disease, or older adults start lower (less than 1.6 mcg/kg/day). It can take 4 to 6 weeks to reach full effect. Squeeze one ampule into water and drink all of it, or squeeze it into the mouth or onto a spoon.
Section
2.1, 2.2, 2.3
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
2.1: Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast. Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption. 2.3 Table 1: Adults diagnosed with hypothyroidism: Full replacement dose is 1.6 mcg/kg/day. Some patients require a lower starting dose. Titrate dosage by 12.5 to 25 mcg increments every 4 to 6 weeks, as needed until the patient is euthyroid. Adults at risk for atrial fibrillation or with underlying cardiac disease: Lower starting dose (less than 1.6 mcg/kg/day). Titrate dosage every 6 to 8 weeks, as needed until the patient is euthyroid. Footnote: Dosages greater than 200 mcg/day are seldom required. An inadequate response to daily dosages greater than 300 mcg/day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors. 2.2: The peak therapeutic effect of a given dose of TIROSINT-SOL may not be attained for 4 to 6 weeks. 2.1 (how to take): To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
Dosage: children
Children's doses depend on weight and age, from 10-15 mcg/kg/day (0-3 months) down to 1.6 mcg/kg/day once growth and puberty are complete (see the label's Table 2). The dose is adjusted about every 2 weeks using blood tests. Babies at risk for cardiac failure start lower, and children at risk for hyperactivity start at one-fourth of the full dose and increase weekly.
Section
2.3 Table 2
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Table 2 (starting daily dosage per kg body weight): 0-3 months: 10-15 mcg/kg/day; 3-6 months: 8-10 mcg/kg/day; 6-12 months: 6-8 mcg/kg/day; 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day; Greater than 12 years but growth and puberty incomplete: 2-3 mcg/kg/day; Growth and puberty complete: 1.6 mcg/kg/day. Titrate the dosage (every 2 weeks) as needed based on serum TSH or free-T4 until the patient is euthyroid. Pediatric Patients from Birth to 3 Months of Age at Risk for Cardiac Failure: Start at a lower starting dosage and increase the dosage every 4 to 6 weeks as needed based on clinical and laboratory response. Pediatric Patients at Risk for Hyperactivity: To minimize the risk of hyperactivity, start at one-fourth the recommended full replacement dosage, and increase on a weekly basis by one-fourth the full recommended replacement dosage until the full recommended replacement dosage is reached.
Dosage adjustments
Drug interaction caps
Space this medicine at least 4 hours from drugs that interfere with its absorption; your prescriber may adjust the dose if you regularly take it within an hour of certain foods.
Section
2.1
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
2.1: Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption. Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption.
Kidney
Confidence
medium
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Liver
Confidence
medium
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Elderly
Older adults start below the full replacement dose because heart disease is more common. Atrial fibrillation is the most common rhythm problem seen with too much levothyroxine in older adults.
Section
8.5
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
8.5 Geriatric Use: Because of the increased prevalence of cardiovascular disease among the elderly, initiate TIROSINT-SOL at less than the full replacement dose. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.
Missed dose
Confidence
low
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Note
The label's Patient Information section was captured only in part; no missed-dose wording was seen in the captured text. Not guessed.
Overdose
Too much causes signs of an overactive thyroid, and can also cause confusion and disorientation. Serious events including cerebral embolism, shock, coma and death have been reported, and symptoms may not appear until several days later. Call poison control at 1-800-222-1222.
Section
10 OVERDOSAGE
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
The signs and symptoms of overdosage are those of hyperthyroidism. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium. Reduce the TIROSINT-SOL dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
Storage
Keep the ampules in the closed pouch at 20°C to 25°C (68°F to 77°F). Use within three (3) months after opening the pouch. Do not store diluted or mixed solution.
Section
16 Storage and Handling; Patient Information
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Store TIROSINT-SOL in the original container (closed pouch) at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Use TIROSINT-SOL oral solution within three (3) months after opening the pouch. Keep the ampules in the pouch until ready to use as important information may be lost. (Patient Information: Do not store the diluted or mixed TIROSINT-SOL solution.)
Boxed warning
Do not use this medicine to lose weight or treat obesity. In people with normal thyroid levels, usual doses do not work for weight loss, and larger doses can cause serious or life-threatening toxicity, especially with sympathomimetic amines used for appetite suppression.
Section
Boxed Warning
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
WARNING: NOT FOR 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
Do not use if you are allergic to glycerol, the inactive ingredient.
Section
4
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Hypersensitivity to glycerol, the inactive ingredient in TIROSINT-SOL.
Do not use if adrenal glands are not working well and this has not been treated.
Section
4
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Uncorrected adrenal insufficiency.
Warnings and precautions
The dose has to be right: too much or too little can harm growth, the heart, bones, reproduction, thinking, digestion, and sugar and fat metabolism. In children, too little can affect thinking and growth, and too much is linked to craniosynostosis and faster bone age.
Heading
5.1 Serious Risks Related to Overtreatment or Undertreatment with TIROSINT-SOL
Section
5.1
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
TIROSINT-SOL has a narrow therapeutic index. Overtreatment or undertreatment with TIROSINT-SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. In pediatric patients with congenital and acquired hypothyroidism, undertreatment may adversely affect cognitive development and linear growth, and overtreatment is associated with craniosynostosis and acceleration of bone age.
Too much can speed the heart and cause chest pain or abnormal rhythms, especially in older people and those with heart disease, who start at lower doses. If heart symptoms start or worsen the dose is reduced or held for one week.
Heading
5.2 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease
Section
5.2
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility, and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate TIROSINT-SOL therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease. If cardiac symptoms develop or worsen, reduce the TIROSINT-SOL dose or withhold it for one week and restart at a lower dose.
Myxedema coma is a life-threatening emergency. Oral thyroid products are not recommended for it; intravenous products are used.
Heading
5.3 Myxedema Coma
Section
5.3
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.
Starting thyroid hormone before glucocorticoid treatment can trigger an acute adrenal crisis in people with adrenal insufficiency, so they are treated with glucocorticoids first.
Heading
5.4 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency
Section
5.4
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with TIROSINT-SOL.
In people with diabetes, blood sugar control may get worse and diabetes medicine or insulin needs may rise. Blood sugar should be monitored closely when starting, changing or stopping.
Heading
5.5 Worsening of Diabetic Control
Section
5.5
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Addition of levothyroxine 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 TIROSINT-SOL.
Too much can weaken bones, especially after menopause, so the lowest dose that works is used.
Heading
5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement
Section
5.6
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. Administer the minimum dose of TIROSINT-SOL that achieves the desired clinical and biochemical response to mitigate this risk.
Pregnancy and breastfeeding
Treatment should not be stopped during pregnancy; the dose may need to go up because pregnancy may increase requirements, and it returns to the pre-pregnancy dose right after delivery. Untreated low thyroid in pregnancy carries risks. Levothyroxine is present in human milk; no adverse effects on breastfed infants have been reported.
Section
8.1, 8.2
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
8.1 Pregnancy: The clinical experience, including data from published postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and TIROSINT-SOL dosage adjusted during pregnancy. TIROSINT-SOL should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. Pregnancy may increase TIROSINT-SOL requirements. Since postpartum TSH levels are similar to preconception values, the TIROSINT-SOL dosage should return to the pre-pregnancy dose immediately after delivery. 8.2 Lactation: Published studies report that levothyroxine is present in human milk following the administration of oral levothyroxine. No adverse effects on the breastfed infant have been reported and this no information on the effects of levothyroxine on milk production.
Side effects
Common
The label does not rank side effects by how often they occur. It says they are mainly signs of too much thyroid hormone: 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.
Section
Highlights / 6
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Threshold
none stated by label
Less common
Confidence
high
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Serious
The label lists these reactions by body system (see source text); they mostly come from too much hormone. Seizures have been reported rarely, and children can have pseudotumor cerebri, slipped capital femoral epiphysis, or craniosynostosis with overtreatment. Allergic reactions to inactive ingredients include hives, itching, rash, angioedema and wheezing. The label does not separate 'serious' from other reactions. MedlinePlus not checked.
Section
6
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Confidence
high
Source text (exact source wording)
Section 6 list: General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating. Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia. Musculoskeletal: tremors, muscle weakness, muscle spasm. Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest. Respiratory: dyspnea. Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests. Dermatologic: hair loss, flushing, rash. Endocrine: decreased bone mineral density. Reproductive: menstrual irregularities, impaired fertility. Seizures have been reported rarely with the institution of levothyroxine therapy. Pediatric: Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants who have not undergone closure of the fontanelles, and in premature closure of the epiphyses in pediatric patients still experiencing growth with resultant compromised adult height. Hypersensitivity: Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing.
Led to discontinuation
Confidence
high
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Interactions
Drugs
Calcium carbonate, ferrous sulfate, sevelamer and lanthanum should be taken at least 4 hours apart. Bile acid sequestrants and ion exchange resins can lower absorption; take this medicine at least 4 hours before them or have TSH monitored. Orlistat calls for monitoring of thyroid function.
Name
Drugs that decrease T4 absorption (phosphate binders, orlistat, bile acid sequestrants, ion exchange resins, sucralfate, antacids)
Section
7.1 Table 5
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum): Phosphate binders may bind to levothyroxine. Administer TIROSINT-SOL at least 4 hours apart from these agents. Orlistat: Monitor patients treated concomitantly with orlistat and TIROSINT-SOL for changes in thyroid function. Bile Acid Sequestrants (e.g., colesevelam, cholestyramine, colestipol) / Ion Exchange Resins (e.g., Kayexalate): Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer TIROSINT-SOL at least 4 hours prior to these drugs or monitor TSH levels.
Sucralfate and antacids may reduce absorption; patients should be monitored.
Name
Sucralfate and antacids
Section
7.1 Table 5
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Sucralfate, Antacids (e.g., aluminum & magnesium hydroxides, simethicone): Gastric acidity is an essential requirement for adequate absorption of levothyroxine. However, gastric acidity may not be as essential for the absorption of TIROSINT-SOL. Sucralfate and antacids may cause hypochlorhydria, affect gastric pH, and reduce levothyroxine absorption. Monitor patients appropriately.
Many drugs change thyroid hormone binding in the blood without changing free thyroxine. The label says to closely monitor thyroid hormone parameters.
Name
Drugs that alter T4/T3 serum transport (estrogens, oral contraceptives, androgens, glucocorticoids, salicylates, carbamazepine, furosemide, heparin, others)
Section
7.1 Table 6
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Table 6 (Euthyroidism): Clofibrate, Estrogen-containing oral contraceptives, Estrogens (oral), Heroin / Methadone, 5-Fluorouracil, Mitotane, Tamoxifen: These drugs may increase serum thyroxine-binding globulin (TBG) concentration. Androgens / Anabolic Steroids, Asparaginase, Glucocorticoids, Slow-Release Nicotinic Acid: These drugs may decrease serum TBG concentration. Salicylates (> 2 g/day): Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. Other drugs: Carbamazepine, Furosemide (> 80 mg IV), Heparin, Hydantoins, Non-Steroidal Anti-inflammatory Drugs: Fenamates: These drugs may cause protein-binding site displacement. Closely monitor thyroid hormone parameters.
Phenobarbital and rifampin speed breakdown of levothyroxine, so more may be needed.
Name
Phenobarbital and rifampin
Section
7.1 Table 7
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased TIROSINT-SOL requirements. Phenobarbital has been shown to reduce the response to thyroxine. Rifampin has been shown to accelerate the metabolism of levothyroxine.
Large doses of propranolol (> 160 mg/day) and dexamethasone (> 4 mg/day), and amiodarone, can reduce conversion of T4 to T3 and change lab values.
Name
Propranolol (> 160 mg/day), dexamethasone (> 4 mg/day), amiodarone
Section
7.1 Table 8
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Beta-adrenergic antagonists (e.g., Propranolol > 160 mg/day): In patients treated with large doses of propranolol (> 160 mg/day), T3 and T4 levels change, TSH levels remain normal, and patients are clinically euthyroid. Glucocorticoids (e.g., Dexamethasone > 4 mg/day): Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. Amiodarone: Amiodarone inhibits peripheral conversion of T4 to T3 and may cause isolated biochemical changes (increase in serum free-T4, and decrease or normal free-T3) in clinically euthyroid patients.
Diabetes medicine or insulin needs may rise; monitor blood sugar.
Name
Antidiabetic therapy
Section
7.2
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Addition of TIROSINT-SOL therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control, especially when thyroid therapy is started, changed, or discontinued.
Blood thinners taken by mouth may work more strongly; clotting tests need close monitoring.
Name
Oral anticoagulants
Section
7.3
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
TIROSINT-SOL increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the TIROSINT-SOL dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.
May reduce the effect of digitalis glycosides, so their dose may need to go up.
Name
Digitalis glycosides
Section
7.4
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
TIROSINT-SOL may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may decrease when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.
Tricyclic or tetracyclic antidepressants can increase effects and toxicity of both drugs, including arrhythmias; sertraline may raise the dose needed.
Name
Tricyclic and tetracyclic antidepressants, sertraline
Section
7.5
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and TIROSINT-SOL may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. TIROSINT-SOL may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on TIROSINT-SOL may result in increased TIROSINT-SOL requirements.
Can cause marked high blood pressure and fast heart rate; monitor closely.
Name
Ketamine
Section
7.6
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Concurrent use of ketamine and TIROSINT-SOL may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.
Effects of either may increase, and coronary insufficiency risk may rise in coronary artery disease.
Name
Sympathomimetics
Section
7.7
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Concurrent use of sympathomimetics and TIROSINT-SOL may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.
May cause low thyroid; TSH should be closely monitored.
Name
Tyrosine-kinase inhibitors (e.g., imatinib)
Section
7.8
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Closely monitor TSH levels in such patients.
Food and alcohol
Name
Certain foods; grapefruit juice
Section
7.9
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Consumption of certain foods may affect TIROSINT-SOL absorption thereby necessitating adjustments in dosing. Soybean flour (infant formula), cottonseed meal, walnuts, and dietary fiber may bind and decrease the absorption of TIROSINT-SOL from the gastrointestinal tract. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability.
Other
Some conditions and drugs change TBG, which can change lab results; free hormone is measured.
Name
Laboratory tests
Section
7.10
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Consider changes in TBG concentration when interpreting T4 and T3 values. Measure and evaluate unbound (free) hormone and/or determine the free-T4 index (FT4I) in this circumstance.
Patient tips
Label patient information
Take once a day, 15 minutes before breakfast on an empty stomach. Keep 4 hours from calcium carbonate or iron. It can take weeks to feel better; keep taking it even if you feel well unless your doctor says to stop. Do not use it for weight loss. For too much, call poison control at 1-800-222-1222. Report side effects to FDA at 1-800-FDA-1088.
Section
Patient Information
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Source text (exact source wording)
Take your dose of TIROSINT-SOL 1 time each day 15 minutes before breakfast on an empty stomach. Take TIROSINT-SOL: at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate); and at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins. Certain foods including soybean flour, cotton seed meal, walnuts, and dietary fiber can affect your treatment and dose of TIROSINT-SOL. Do not remove TIROSINT-SOL ampules from the sealed aluminum foil pouch until you are ready to use them. Keep taking TIROSINT-SOL unless your doctor tells you to stop or to change your dose. It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well. If you take too much TIROSINT-SOL, call your doctor, your Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away. Do not use TIROSINT-SOL to treat weight problems or weight loss. Call your doctor for medical advice about side effects. You may report side effects to IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800-FDA-1088.
Alternatives
Note
Label states Tirosint-SOL is L-thyroxine (T4) for hypothyroidism.
Frequently asked questions
Question
What is Tirosint-SOL used for?
Answer
It replaces thyroid hormone in adults and children, including newborns, when the thyroid, pituitary or hypothalamus does not make enough, and it is used with surgery and radioiodine therapy for a type of thyroid cancer.
Source section
1 INDICATION AND USAGE
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
When and how should I take it?
Answer
Take it once a day on an empty stomach, 15 minutes before breakfast. Squeeze one ampule into water and drink all of it, or squeeze it into the mouth or onto a spoon.
Source section
2.1
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
Can I take it with calcium or iron?
Answer
Take it at least 4 hours before or after medicines that contain calcium carbonate or iron (ferrous sulfate).
Source section
Patient Information
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
Do foods or grapefruit affect it?
Answer
Soybean flour, cottonseed meal, walnuts and dietary fiber can lower absorption, and grapefruit juice may delay absorption. Talk to your doctor if you eat or drink these foods.
Source section
7.9
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
Can I use it to lose weight?
Answer
No. The boxed warning says thyroid hormones should not be used for obesity or weight loss, and larger doses can cause serious or life-threatening toxicity.
Source section
Boxed Warning
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
Is it safe in pregnancy and breastfeeding?
Answer
The label says it should not be stopped during pregnancy and the dose may need to increase. Levothyroxine is present in human milk and no adverse effects on breastfed infants have been reported.
Source section
8.1, 8.2
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
Should I stop when I feel well?
Answer
No. Keep taking it unless your doctor tells you to stop or change your dose. It may take weeks before you notice symptoms getting better.
Source section
Patient Information
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Question
What if I take too much?
Answer
Call your doctor, Poison Control at 1-800-222-1222, or go to the nearest emergency room right away.
Source section
Patient Information; 10
Source
DailyMed printer-friendly label, IBSA Pharma Inc., set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7
Sources
- DailyMed Tirosint-SOL (IBSA Pharma Inc.)
Set id: 5d378add-f13d-40f2-99dc-0f2340ab44b7 · Label effective or revised date: Revised: 7/2024 (Highlights); label text also shows 'Revised: 3/2026' · Dailymed version date: DailyMed page: Updated March 27, 2026; list API published Mar 30, 2026 · Fetched at: 2026-11-02 · Sections used: Boxed warning, 1-8, 10-12, 16, 17, Patient Information
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug