Tirosint-Sol

Tirosint-Sol (levothyroxine sodium) oral solution is L- thyroxine (T4) indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism; and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Tirosint-Sol is available in generic form. Common side effects of Tirosint-Sol are primarily those of hyperthyroidism due to therapeutic overdosage, and include:

• irregular heart beat (arrhythmias),
• heart attack,
• shortness of breath,
• muscle spasm,
• headache,
• nervousness,
• irritability,
• insomnia,
• tremors,
• muscle weakness,
• increased appetite,
• weight loss,
• diarrhea,
• heat intolerance,
• menstrual irregularities, and
• skin rash.

The dose of Tirosint-Sol is administered once daily, on an empty stomach, one-half to one hour before breakfast. Administer Tirosint-Sol at least 4 hours before or after drugs that are known to interfere with absorption. Tirosint-Sol may interact with calcium carbonate, ferrous sulfate, orlistat, bile acid sequestrants, ion exchange resins, proton pump inhibitors, sucralfate, antacids, clofibrate, estrogen-containing oral contraceptives, estrogens (oral), heroin/methadone, 5-fluorouracil, mitotane, tamoxifen, androgens/anabolic steroids, asparaginase, glucocorticoids, slow-release nicotinic acid, salicylates, carbamazepine, furosemide, heparin, hydantoin, nonsteroidal anti-inflammatory drugs (NSAIDs), Phenobarbital, Rifampin, beta-adrenergic antagonists, glucocorticoids, Amiodarone, antidiabetics or insulin, oral anticoagulants, digitalis glycosides, antidepressants, ketamine, sympathomimetics, thyroid hormone, tyrosine-kinase inhibitors, and grapefruit juice. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Tirosint-Sol. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Tirosint-Sol may pass into breast milk. Consult your doctor before breastfeeding.

Our Tirosint-Sol (levothyroxine sodium) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tirosint-Sol Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or irregular heartbeats;
• chest pain, pain spreading to your jaw or shoulder;
• shortness of breath;
• fever, hot flashes, sweating;
• tremors, or if you feel unusually cold;
• weakness, tiredness, sleep problems (insomnia);
• memory problems, feeling depressed or irritable;
• headache, leg cramps, muscle aches;
• feeling nervous or irritable;
• dryness of your skin or hair, hair loss;
• irregular menstrual periods; or
• vomiting, diarrhea, appetite changes, weight changes.

Certain side effects may be more likely in older adults.

Common side effects may include:

• chest pain, irregular heartbeats;
• shortness of breath;
• headache, leg cramps, muscle pain or weakness;
• tremors, feeling nervous or irritable, trouble sleeping;
• increased appetite;
• feeling hot;
• weight loss;
• changes in your menstrual periods;
• diarrhea; or
• skin rash, partial hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tirosint-Sol (Levothyroxine Sodium Oral Solution)

 

Tirosint-Sol Professional Information

SIDE EFFECTS

Adverse reactions associated with TIROSINT-SOL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see WARNINGS AND PRECAUTIONS and OVERDOSE]. They include the following:

• 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.

Adverse Reactions In Children

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height.

Hypersensitivity Reactions

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. Hypersensitivity to levothyroxine itself is not known to occur.

Read the entire FDA prescribing information for Tirosint-Sol (Levothyroxine Sodium Oral Solution)