Tirosint-Sol 125mcg/ml Oral Sol
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Take your medication on an empty stomach, 15 minutes before breakfast.
You can take the medication directly in your mouth or mix it with water. If mixing with water, empty the contents into a cup with water and squeeze the container over the cup at least 5 times until no more medication comes out. Stir well.
Take your dose immediately after mixing. Do not store the mixture for future use.
Rinse the cup with more water and drink.
Take your medication with water only; do not take it with other drinks.
Important Interactions to Consider
Do not take iron products, antacids that contain aluminum or magnesium, or calcium carbonate within 4 hours before or 4 hours after taking your medication.
If you take other medications, they may need to be taken at a different time than your current medication. Check with your doctor or pharmacist to determine the best schedule.
Certain foods, such as soybean flour (found in infant formula), may affect how your medication works in your body. Discuss this with your doctor.
If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor about potential interactions.
Using the Correct Form of Your Medication
There are different brands and forms of this medication. Do not switch between different brands or forms without consulting your doctor.
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
Keep your medication in its foil pouch until you are ready to use it.
What to Do If You Miss a Dose
Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Tirosint-SOL exactly as prescribed, usually once a day in the morning, on an empty stomach, at least 30-60 minutes before breakfast.
- Wait at least 4 hours after taking Tirosint-SOL before taking any iron supplements, calcium supplements, antacids, or other medications that can interfere with absorption.
- Do not mix Tirosint-SOL with other liquids or food. Administer directly into the mouth or with a spoon.
- Do not stop taking this medication without talking to your doctor, even if you feel better. Lifelong therapy is often required.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with levothyroxine.
- Maintain a consistent diet; avoid sudden changes in soy intake or high-fiber foods, as they can affect absorption.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
- Tirosint 13mcg Capsules
- Tirosint 25mcg Capsules
- Tirosint 50mcg Capsules
- Tirosint 75mcg Capsules
- Tirosint 88mcg Capsules
- Tirosint 150mcg Capsules
- Tirosint 137mcg Capsules
- Tirosint 100mcg Capsules
- Tirosint 112mcg Capsules
- Tirosint 125mcg Capsules
- Tirosint 175mcg Capsules
- Tirosint 200mcg Capsules
- Tirosint-Sol 100mcg/ml Oral Sol
- Tirosint-Sol 137mcg/ml Oral Sol
- Tirosint-Sol 150mcg/ml Oral Sol
- Tirosint-Sol 175mcg/ml Oral Sol
- Tirosint-Sol 88mcg/ml Oral Sol
- Tirosint-Sol 200mcg/ml Oral Sol
- Tirosint-Sol 13mcg/ml Oral Sol
- Tirosint-Sol 25mcg/ml Oral Sol
- Tirosint-Sol 50mcg/ml Oral Sol
- Tirosint-Sol 112mcg/ml Oral Sol
- Tirosint-Sol 75mcg/ml Oral Sol
- Tirosint-Sol 125mcg/ml Oral Sol
- Tirosint-Sol 37.5mcg/ml Oral Sol
- Tirosint-Sol 44mcg/ml Oral Sol
- Tirosint-Sol 62.5mcg/ml Oral Sol
- Tirosint 37.5mcg Capsules
- Tirosint 44mcg Capsules
- Tirosint 62.5mcg Capsules
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Headache
Feeling tired or weak
Changes in appetite
Unintentional weight changes
Diarrhea, stomach cramps, or vomiting
Mood changes, such as irritability, nervousness, excitability, anxiety, or other emotional changes
Shakiness
Trouble sleeping
Sensitivity to heat
Excessive sweating
Fever
Muscle cramps
Muscle weakness
Flushing
Bone pain
Changes in menstrual periods
In children: hip or knee pain, or a limp
In infants: changes in the shape of the head and face
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:
* Hair loss (usually temporary and resolves on its own within the first few months of treatment)
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of too much thyroid hormone (hyperthyroidism): rapid heart rate, palpitations, chest pain, nervousness, tremors, excessive sweating, heat intolerance, unexplained weight loss, diarrhea, insomnia.
- Symptoms of too little thyroid hormone (hypothyroidism) if dose is too low or missed: extreme fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, slow heart rate.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Overactive thyroid gland (hyperthyroidism)
+ Weak adrenal gland (adrenal insufficiency)
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure continuous treatment, do not allow your supply of this medication to run out. You may not experience the full effects of this medication for several weeks.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar control. Your doctor may need to adjust your diabetes medications. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as advised.
When taking biotin or products containing biotin, stop using them at least 2 days before having your thyroid levels checked to ensure accurate test results.
Potential Risks and Side Effects
High doses of this medication may increase the risk of developing weak bones (osteoporosis), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at a higher risk of osteoporosis.
This medication may also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to conceive, consult your doctor before starting treatment.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication for both you and your baby.
Pediatric Patients
When administering this medication to a child, monitor their weight changes and consult your doctor, as the dosage may need to be adjusted. Never give your child more than the prescribed dose, as this may increase the risk of severe side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Palpitations
- Tachycardia
- Arrhythmias
- Chest pain
- Tremor
- Nervousness
- Insomnia
- Diaphoresis
- Heat intolerance
- Weight loss
- Diarrhea
- Vomiting
- Fever
- Seizures (rare)
- Cardiac arrest (rare)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive, often involving beta-blockers for cardiac symptoms and measures to reduce absorption if recent ingestion.
Drug Interactions
Contraindicated Interactions
- Uncorrected adrenal insufficiency (risk of acute adrenal crisis)
- Acute myocardial infarction (unless due to hypothyroidism)
- Untreated thyrotoxicosis
Major Interactions
- Amiodarone (alters thyroid hormone metabolism)
- Antacids (aluminum, magnesium, calcium) - decrease absorption
- Bile acid sequestrants (cholestyramine, colestipol) - decrease absorption
- Cation exchange resins (sodium polystyrene sulfonate) - decrease absorption
- Iron supplements - decrease absorption
- Sucralfate - decrease absorption
- Proton pump inhibitors (PPIs) - decrease absorption (due to increased gastric pH)
- Soy products - decrease absorption
- Orlistat - decrease absorption
- Warfarin (enhances anticoagulant effect)
- Antidiabetic agents (may increase blood glucose, requiring dose adjustment)
- Sympathomimetics (increased risk of cardiac effects)
- Tyrosine kinase inhibitors (e.g., imatinib, sunitinib) - may increase levothyroxine requirements
Moderate Interactions
- Estrogens (increase TBG, may increase levothyroxine requirements)
- Androgens (decrease TBG, may decrease levothyroxine requirements)
- Glucocorticoids (may inhibit TSH secretion and T4 to T3 conversion)
- Beta-blockers (may decrease T4 to T3 conversion)
- Carbamazepine, Phenytoin, Rifampin (increase levothyroxine metabolism)
- Sertraline (may increase levothyroxine requirements)
- Dietary fiber (may decrease absorption)
Minor Interactions
- Coffee (may decrease absorption, separate administration)
- Grapefruit juice (potential minor effect on absorption)
Monitoring
Baseline Monitoring
Rationale: To establish baseline thyroid function and confirm diagnosis of hypothyroidism.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline thyroid hormone levels.
Timing: Prior to initiation of therapy.
Rationale: To assess for underlying cardiac conditions, especially in elderly or those with known heart disease, as thyroid hormone replacement can exacerbate cardiac symptoms.
Timing: Prior to initiation, particularly in at-risk patients.
Routine Monitoring
Frequency: Every 4-6 weeks after initiation or dose change, then every 6-12 months once stable.
Target: Typically 0.4-4.0 mIU/L (individualized based on patient age, comorbidities, and specific clinical goals).
Action Threshold: Adjust dose if TSH is outside target range.
Frequency: May be monitored with TSH, especially in central hypothyroidism or when TSH is unreliable.
Target: Typically 0.8-1.8 ng/dL (individualized).
Action Threshold: Adjust dose if Free T4 is outside target range.
Frequency: At each visit.
Target: Resolution or improvement of hypothyroid symptoms.
Action Threshold: Consider dose adjustment or further investigation if symptoms persist despite adequate lab values.
Symptom Monitoring
- Fatigue
- Weight changes (gain or loss)
- Cold intolerance
- Constipation
- Dry skin
- Hair loss
- Bradycardia
- Depression
- Memory impairment
- Muscle aches
- Hoarseness
- Swelling (myxedema)
- Palpitations (sign of overtreatment)
- Nervousness (sign of overtreatment)
- Tremor (sign of overtreatment)
- Heat intolerance (sign of overtreatment)
Special Patient Groups
Pregnancy
Levothyroxine is safe and essential during pregnancy. Hypothyroidism must be treated adequately to prevent adverse maternal and fetal outcomes. Dose requirements often increase during pregnancy (by 25-50% or more) due to increased TBG and fetal thyroid hormone needs.
Trimester-Specific Risks:
Lactation
Levothyroxine is compatible with breastfeeding. Only small amounts are excreted into breast milk, which are not clinically significant to the infant. It is considered safe for use by nursing mothers.
Pediatric Use
Dosing is weight-based and higher per kg than in adults, especially in neonates and infants, due to rapid growth and development. Regular monitoring of TSH and T4 is critical to ensure proper neurocognitive development. Tirosint-SOL may be particularly useful for pediatric patients due to its liquid formulation and ease of administration.
Geriatric Use
Lower initial doses (e.g., 12.5-25 mcg/day) are recommended, especially in patients with underlying cardiac disease, to avoid precipitating cardiac events. Dose titration should be slower and more cautious. Monitor for signs of overtreatment (e.g., angina, arrhythmias).
Clinical Information
Clinical Pearls
- Tirosint-SOL is an oral solution of levothyroxine, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those who have difficulty swallowing pills, as it contains fewer excipients than tablet formulations.
- Always administer Tirosint-SOL on an empty stomach, at least 30-60 minutes before breakfast, and at least 4 hours apart from interacting medications/supplements.
- Consistency is key: take the medication at the same time each day and avoid missing doses.
- TSH is the primary lab test for monitoring, but Free T4 may be useful in certain situations (e.g., central hypothyroidism, pregnancy, or when TSH is suppressed).
- Patients should be educated on symptoms of both under- and over-treatment.
- The black box warning regarding use for weight loss in euthyroid patients is critical to emphasize.
Alternative Therapies
- Levothyroxine tablets (Synthroid, Levoxyl, Unithroid, Euthyrox, Tirosint)
- Liothyronine (Cytomel, Triostat) - T3 hormone, shorter half-life, used in specific cases or in combination with levothyroxine.
- Desiccated thyroid extract (Armour Thyroid, Nature-Throid) - natural thyroid hormone from porcine glands, contains both T4 and T3.