Tirosint-Sol 13mcg/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.
Store your medication in its foil pouch until you are ready to use it.
What to Do If You Miss a Dose
If you miss a dose, take it 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 once daily, preferably in the morning, at least 30-60 minutes before breakfast and any other medications or supplements.
- Take it consistently at the same time each day.
- Do not mix Tirosint-SOL with other liquids or food.
- Separate administration from calcium, iron, antacids, and other interacting medications by at least 4 hours.
- Do not stop taking this medication without consulting your doctor, even if you feel better.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regular blood tests (TSH) are necessary to ensure the correct dose.
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 medical attention immediately:
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 feeling irritable, nervous, excitable, or anxious
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 may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Hair loss (usually temporary and resolves on its own)
Other side effects not listed here
If you have questions or concerns about side effects, contact 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, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, insomnia, weight loss, diarrhea.
- Symptoms of too little thyroid hormone (hypothyroidism): extreme tiredness, weight gain, constipation, cold intolerance, dry skin, hair loss, depression, slow heart rate.
- Seek immediate medical attention if you experience chest pain, shortness of breath, or severe palpitations.
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 safe treatment, 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 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 uninterrupted treatment, do not allow your supply of this medication to run out. Please note that it may take several weeks to experience the full effects of this medication.
Special Considerations
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect blood sugar control. Your doctor may need to adjust your diabetes medications. Be sure to monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.
If you are taking biotin or a product containing biotin, stop taking it 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 individual risk factors with your doctor, and ask about any concerns you may have.
This medication may also affect fertility, potentially leading to difficulties in getting pregnant or fathering a child. If you plan to become pregnant or father a child, consult with your doctor before starting this medication.
Age-Related Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication for you and your baby.
Pediatric Patients
If you are giving this medication to a child and their weight changes, consult with your doctor, as the dosage may need to be adjusted. Never give your child more of this medication than prescribed, 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 be sure to discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Palpitations
- Tachycardia
- Arrhythmias
- Chest pain
- Tremor
- Nervousness
- Insomnia
- Diaphoresis
- Heat intolerance
- Weight loss
- Diarrhea
- Vomiting
- Fever
- Seizures (rare)
- Heart failure (rare)
What to Do:
Contact a poison control center immediately (Call 1-800-222-1222). Treatment is symptomatic and supportive, including reducing absorption (e.g., activated charcoal if recent ingestion), and managing cardiovascular effects (e.g., beta-blockers for tachycardia). Discontinuation or dose reduction of levothyroxine may be necessary.
Drug Interactions
Major Interactions
- Amiodarone (alters thyroid hormone metabolism)
- Oral anticoagulants (e.g., warfarin - enhances anticoagulant effect)
- Ion exchange resins (e.g., cholestyramine, colestipol - reduce absorption)
- Sucralfate (reduces absorption)
- Proton pump inhibitors (e.g., omeprazole - may reduce absorption)
- Iron supplements (reduce absorption)
- Calcium supplements (reduce absorption)
- Aluminum-containing antacids (reduce absorption)
- Sevelamer (reduces absorption)
- Orlistat (reduces absorption)
- Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - may increase levothyroxine requirements)
- Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
Moderate Interactions
- Beta-blockers (may reduce T4 to T3 conversion)
- Estrogens (increase TBG, increasing levothyroxine requirements)
- Androgens (decrease TBG, decreasing levothyroxine requirements)
- Corticosteroids (may alter thyroid hormone metabolism)
- Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
- Digoxin (may decrease digoxin levels)
Minor Interactions
- Dietary fiber (may reduce absorption)
Monitoring
Baseline Monitoring
Rationale: To confirm diagnosis of hypothyroidism and establish baseline.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline thyroid hormone levels, especially in central hypothyroidism or when TSH is unreliable.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline symptom severity and guide treatment goals.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Every 4-6 weeks after initiation or dose change, then every 6-12 months once stable.
Target: 0.4-4.0 mIU/L (individualized based on patient age, comorbidities, and specific condition, e.g., TSH suppression for thyroid cancer).
Action Threshold: Adjust dose if TSH is outside target range.
Frequency: At each visit, especially during dose titration.
Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.
Action Threshold: Adjust dose if symptoms persist or new symptoms develop.
Frequency: Consider if TSH is suppressed, in central hypothyroidism, or if TSH is unreliable.
Target: Within normal reference range (e.g., 0.8-1.8 ng/dL), or individualized.
Action Threshold: Adjust dose if Free T4 is outside target range, especially if TSH is not a reliable indicator.
Symptom Monitoring
- Fatigue
- Weight gain
- Constipation
- Cold intolerance
- Dry skin
- Hair loss
- Bradycardia
- Depression
- Anxiety
- Palpitations
- Tremor
- Heat intolerance
- Diarrhea
- Weight loss
- Tachycardia
- Insomnia
Special Patient Groups
Pregnancy
Levothyroxine is the drug of choice for hypothyroidism during pregnancy. Thyroid hormone requirements typically increase during pregnancy, often by 25-50% or more. Close monitoring of TSH is essential.
Trimester-Specific Risks:
Lactation
Levothyroxine is considered safe during breastfeeding. Minimal amounts are excreted into breast milk, and it does not adversely affect the infant.
Pediatric Use
Dosing is weight-based and generally higher per kilogram in younger children due to higher metabolic rates and rapid growth. Close monitoring of TSH and clinical status is crucial to ensure proper growth and neurocognitive development. Tirosint-SOL may be particularly useful for infants and children who cannot swallow tablets or have absorption issues.
Geriatric Use
Lower initial doses (e.g., 12.5-25 mcg/day) are recommended, especially in patients with underlying cardiovascular disease, due to increased sensitivity to thyroid hormones. Titration should be slower and more cautious, with smaller increments. Monitor for cardiac symptoms.
Clinical Information
Clinical Pearls
- Tirosint-SOL is a liquid formulation that may be beneficial for patients with swallowing difficulties, malabsorption issues, or sensitivities to excipients found in tablet formulations.
- Always take levothyroxine on an empty stomach, ideally 30-60 minutes before breakfast, and separate from other medications and supplements by at least 4 hours.
- Consistency is key: take it at the same time each day and avoid switching between different brands or formulations without consulting your doctor, as bioavailability can vary.
- TSH is the primary lab test for monitoring, but Free T4 may be useful in specific situations (e.g., central hypothyroidism, TSH suppression therapy).
- Patients often require dose adjustments during pregnancy, with aging, or if starting/stopping interacting medications.
Alternative Therapies
- Other levothyroxine sodium formulations (tablets, capsules like Tirosint)
- Liothyronine (T3) (e.g., Cytomel, Triostat) - typically used in specific situations or in combination with levothyroxine.
- Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from animal thyroid glands.