Tirosint-Sol 88mcg/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 precisely.
Take your medication on an empty stomach, 15 minutes before breakfast.
You can take the medication directly into your mouth or mix it with water. To mix 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 containing 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. Consult 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 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 resume 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, on an empty stomach, at least 30-60 minutes before breakfast.
- Do not mix Tirosint-SOL with water or other liquids. Administer directly into the mouth or onto a spoon.
- Separate administration of Tirosint-SOL from calcium, iron, antacids, and other medications by at least 4 hours to ensure proper absorption.
- Take consistently at the same time each day.
- 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.
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
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
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 women)
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 within the first few months of treatment)
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, shortness of breath, excessive sweating, heat intolerance, nervousness, tremor, insomnia, weight loss, diarrhea.
- Symptoms of too little thyroid hormone (hypothyroidism) despite treatment: persistent fatigue, weight gain, constipation, cold intolerance, dry skin, hair loss, depression.
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 making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, 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 run out of this medication, as it may take several weeks to experience its full effects.
Special Considerations
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect 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 recommended.
If you take biotin or products 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 osteoporosis (weak bones), particularly after menopause. Discuss your risk factors with your doctor and address 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 conceive, consult your doctor before starting treatment.
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 your child is taking this medication and experiences weight changes, consult your doctor, as the dosage may need to be adjusted. Never give your child more 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. Consult your doctor to discuss any concerns.
Overdose Information
Overdose Symptoms:
- Palpitations
- Tachycardia
- Arrhythmias
- Chest pain (angina)
- Tremor
- Nervousness
- Insomnia
- Diarrhea
- Weight loss
- Fever
- Heat intolerance
- Seizures (rare)
- Heart failure (in susceptible individuals)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive and symptomatic, often involving beta-blockers for cardiac symptoms and measures to reduce absorption if recent ingestion.
Drug Interactions
Major Interactions
- Amiodarone (can cause hypo- or hyperthyroidism, alters T4 to T3 conversion)
- Certain antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital - increase levothyroxine metabolism)
- Rifampin (increases levothyroxine metabolism)
- Tyrosine kinase inhibitors (e.g., imatinib, sunitinib - can affect thyroid function and increase levothyroxine requirements)
- Orlistat (can reduce levothyroxine absorption)
Moderate Interactions
- Calcium carbonate/supplements (reduce absorption, separate by 4 hours)
- Iron supplements (ferrous sulfate, etc. - reduce absorption, separate by 4 hours)
- Antacids (aluminum hydroxide, magnesium hydroxide - reduce absorption, separate by 4 hours)
- Proton pump inhibitors (e.g., omeprazole, lansoprazole - increase gastric pH, potentially reducing absorption, monitor TSH)
- Sucralfate (reduces absorption, separate by 4 hours)
- Cholestyramine, colestipol, sevelamer (bile acid sequestrants - reduce absorption, separate by 4-6 hours)
- Soy products (can reduce absorption, monitor TSH)
- Dietary fiber (can reduce absorption, monitor TSH)
- Warfarin (levothyroxine can enhance anticoagulant effect, monitor INR)
- Beta-blockers (may reduce conversion of T4 to T3)
- Estrogens (increase TBG, may increase levothyroxine requirements)
- Androgens (decrease TBG, may decrease levothyroxine requirements)
- Corticosteroids (can inhibit TSH secretion and T4 to T3 conversion)
Minor Interactions
- Certain foods (e.g., grapefruit juice, coffee - may slightly affect absorption, consistency is key)
- Multivitamins with minerals (separate administration)
Monitoring
Baseline Monitoring
Rationale: Primary diagnostic and monitoring tool for hypothyroidism. Reflects the body's response to thyroid hormone levels.
Timing: Before initiation of therapy.
Rationale: Measures the unbound, active form of T4. Useful in conjunction with TSH, especially in central hypothyroidism or when TSH is unreliable.
Timing: Before initiation of therapy.
Rationale: To establish baseline symptoms (e.g., fatigue, weight gain, constipation, cold intolerance) for assessing treatment efficacy.
Timing: Before initiation of therapy.
Rationale: To assess for underlying cardiac conditions, as thyroid hormone replacement can exacerbate cardiac symptoms, especially in elderly or those with pre-existing heart disease.
Timing: Before initiation of therapy, particularly in older adults or those with cardiac risk factors.
Routine Monitoring
Frequency: Every 4-6 weeks after initiation or any dose change, until stable. Once stable, annually or as clinically indicated.
Target: Typically 0.4-4.0 mIU/L (euthyroid range), but target may vary based on patient age, comorbidities, and specific clinical situation (e.g., pregnancy, thyroid cancer).
Action Threshold: If TSH is outside target range, adjust levothyroxine dose. If TSH is high, increase dose; if TSH is low, decrease dose.
Frequency: Often checked with TSH, especially if TSH is suppressed or in central hypothyroidism. Less frequently needed once TSH is stable.
Target: Typically 0.8-1.8 ng/dL (euthyroid range).
Action Threshold: Used to guide dose adjustments, particularly when TSH is not a reliable indicator.
Frequency: At every follow-up visit.
Target: Resolution of hypothyroid symptoms; absence of hyperthyroid symptoms (e.g., palpitations, anxiety, weight loss, heat intolerance).
Action Threshold: Persistent hypothyroid symptoms or emergence of hyperthyroid symptoms indicate need for dose adjustment and/or further investigation.
Symptom Monitoring
- Fatigue
- Weight changes (gain or loss)
- Cold or heat intolerance
- Constipation or diarrhea
- Dry skin or hair loss
- Muscle aches or weakness
- Depression or anxiety
- Memory impairment
- Bradycardia or tachycardia
- Palpitations
- Tremor
- Nervousness
- Insomnia
Special Patient Groups
Pregnancy
Levothyroxine requirements typically increase during pregnancy. It is crucial to maintain euthyroidism to support fetal neurological development. TSH levels should be monitored closely (e.g., every 4-6 weeks) and dose adjusted as needed.
Trimester-Specific Risks:
Lactation
Levothyroxine is considered safe during breastfeeding. Only small amounts are excreted into breast milk, and it does not adversely affect the nursing infant. Maternal thyroid hormone replacement is important for the mother's health and ability to care for the infant.
Pediatric Use
Dosing is weight-based and critical for normal growth and neurological development. Regular monitoring of TSH and FT4 is essential. Adherence is crucial, especially in infants and young children, to prevent irreversible developmental delays.
Geriatric Use
Lower starting doses (e.g., 12.5-25 mcg/day) are often recommended due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiovascular disease. Dose titration should be slower and more cautious. Monitor for cardiac symptoms.
Clinical Information
Clinical Pearls
- Tirosint-SOL is an oral solution, which may be beneficial for patients with absorption issues (e.g., gastric bypass, celiac disease, lactose intolerance) or those who have difficulty swallowing pills.
- Always take levothyroxine on an empty stomach, consistently 30-60 minutes before breakfast, and separate from other medications and supplements by at least 4 hours.
- The 88mcg/ml concentration means 1 ml contains 88 mcg of levothyroxine. Dosing should be precise using the provided oral syringe.
- Patients should be advised that it takes several weeks for the full therapeutic effect to be seen and for TSH levels to stabilize after a dose change.
- Educate patients on symptoms of both under- and over-treatment to ensure timely reporting and dose adjustments.
- Consistency in brand and formulation is generally recommended due to narrow therapeutic index and potential for bioavailability differences between products.
Alternative Therapies
- Other levothyroxine formulations (tablets, capsules, softgel capsules, IV injection)
- Liothyronine (T3) - used in specific cases, often in combination with levothyroxine
- Desiccated thyroid extract (e.g., Armour Thyroid, Nature-Throid) - contains both T4 and T3, derived from porcine thyroid glands.