Tirosint-Sol 137mcg/ml Oral Sol
WARNING: Do not use this drug for weight loss. Severe and sometimes deadly side effects may happen with this drug if it is taken in large doses or with other drugs for weight loss. If you have questions, talk with the doctor. @ COMMON USES: It is used to add thyroid hormone to the body.It is used to manage thyroid cancer.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Thyroid hormone
Pharmacologic Class
Thyroid hormone replacement
Pregnancy Category
A
FDA Approved
Aug 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tirosint-SOL is a liquid medicine containing a synthetic thyroid hormone called levothyroxine. It's used to replace the thyroid hormone that your body isn't making enough of, which helps regulate your body's energy and metabolism. It's especially useful for people who have difficulty swallowing pills or have absorption issues with tablet forms.
How to Use This Medicine
Taking Your Medication
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 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 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
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.
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 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 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
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 on an empty stomach, preferably 30-60 minutes before breakfast, with a full glass of water.
- Take at the same time each day for consistent absorption.
- Do not take with food, coffee, or other medications/supplements (especially iron, calcium, antacids) within 4 hours.
- Do not switch between different brands or formulations of levothyroxine without consulting your doctor, as doses may not be equivalent.
- Report any new or worsening symptoms to your doctor.
- Do not use for weight loss.
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
Standard Dose:
Highly individualized. Initial dose typically 1.6 mcg/kg/day for primary hypothyroidism. Adjust by 12.5-25 mcg increments every 4-6 weeks based on TSH levels.
Dose Range:
25 - 300 mg
Condition-Specific Dosing:
cardiacDisease:
Initial dose 12.5-25 mcg/day, titrate slowly.
longStandingHypothyroidism:
Initial dose 12.5-50 mcg/day, titrate slowly.
Pediatric Dosing
Neonatal:
10-15 mcg/kg/day (0-3 months)
Infant:
6-8 mcg/kg/day (3-6 months); 5-6 mcg/kg/day (6-12 months)
Child:
4-5 mcg/kg/day (1-5 years); 3-4 mcg/kg/day (6-12 years)
Adolescent:
2-3 mcg/kg/day (12-17 years, growth and puberty complete: 1.6 mcg/kg/day)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, monitor TSH.
Moderate:
No specific adjustment needed, monitor TSH.
Severe:
No specific adjustment needed, monitor TSH.
Dialysis:
No specific adjustment needed, monitor TSH.
Hepatic Impairment:
Mild:
No specific adjustment needed, monitor TSH.
Moderate:
No specific adjustment needed, monitor TSH.
Severe:
No specific adjustment needed, monitor TSH.
Pharmacology
Mechanism of Action
Levothyroxine sodium is a synthetic L-isomer of thyroxine (T4), which is converted to its active metabolite, L-triiodothyronine (T3), in peripheral tissues. T3 and T4 bind to thyroid hormone receptors in the cell nucleus, regulating gene expression and controlling numerous cellular processes involved in metabolism, growth, and development.
Pharmacokinetics
Absorption:
Bioavailability:
40-80% (variable, affected by food and other drugs). Tirosint-SOL may have more consistent absorption due to its formulation.
Tmax:
2-4 hours
FoodEffect:
Food significantly decreases absorption. Should be taken on an empty stomach, 30-60 minutes before breakfast.
Distribution:
Vd:
Approximately 10-13 L
ProteinBinding:
>99% (primarily to thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7 days (euthyroid individuals); 9-10 days (hypothyroid); 3-4 days (hyperthyroid)
Clearance:
Approximately 0.05 L/hr/kg
ExcretionRoute:
Primarily renal (conjugated metabolites), some fecal.
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Gradual, effects typically seen within 3-5 days, but full therapeutic effect may take 4-6 weeks.
PeakEffect:
4-6 weeks (based on TSH normalization)
DurationOfAction:
Due to long half-life, effects persist for several days after discontinuation.
Safety & Warnings
BLACK BOX WARNING
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.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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
Vomiting
Mood changes, such as:
+ Irritability
+ Nervousness
+ Excitability
+ Anxiety
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
+ Limping
In infants:
+ Changes in the shape of the head and face
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, 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, 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.
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
Vomiting
Mood changes, such as:
+ Irritability
+ Nervousness
+ Excitability
+ Anxiety
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
+ Limping
In infants:
+ Changes in the shape of the head and face
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, 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, 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, excessive sweating, heat intolerance, nervousness, tremor, unexplained 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
Before Taking This Medication: Important Information to Share with Your Doctor
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:
+ An overactive thyroid gland
+ A weak adrenal gland
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
Any natural products or vitamins you are using
* Your health problems
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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:
+ An overactive thyroid gland
+ A weak adrenal gland
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
Any natural products or vitamins you are using
* Your health problems
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information for All Patients Taking This Medication
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. Be sure to monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.
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 osteoporosis (weak bones), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at higher risk.
This medication may also affect fertility, potentially leading to difficulty 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
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to 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 than the prescribed dose, as this can 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 determine the best course of action.
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. Be sure to monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.
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 osteoporosis (weak bones), particularly after menopause. Discuss your risk factors with your doctor, who can help determine if you are at higher risk.
This medication may also affect fertility, potentially leading to difficulty 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
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to 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 than the prescribed dose, as this can 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 determine the best course of action.
Overdose Information
Overdose Symptoms:
- Palpitations
- Tachycardia
- Arrhythmias
- Chest pain
- Tremor
- Nervousness
- Insomnia
- Diaphoresis
- Heat intolerance
- Weight loss
- Diarrhea
- Vomiting
- Fever
- Seizures (rare)
- Heart failure (in susceptible individuals)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive, often involving beta-blockers for cardiac symptoms.
Drug Interactions
Major Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol)
- Ion exchange resins (e.g., sevelamer, patiromer)
- Calcium carbonate/supplements
- Iron supplements
- Aluminum hydroxide (antacids)
- Sucralfate
- Proton pump inhibitors (e.g., omeprazole, lansoprazole)
- Soy products/dietary fiber
- Amiodarone
- Beta-blockers (e.g., propranolol)
- Corticosteroids
- Propylthiouracil (PTU)
- Warfarin (potentiates anticoagulant effect)
- Sympathomimetics (e.g., pseudoephedrine, epinephrine)
Moderate Interactions
- Antidiabetic agents (may increase insulin/oral hypoglycemic requirements)
- Digoxin (may decrease digoxin levels)
- SSRIs (e.g., sertraline)
- Tricyclic antidepressants (e.g., imipramine)
- Oral contraceptives/estrogens (increase TBG, may increase levothyroxine requirement)
- Androgens/anabolic steroids (decrease TBG, may decrease levothyroxine requirement)
- Phenytoin, Carbamazepine, Rifampin (increase levothyroxine metabolism)
- Iodine-containing products
Confidence Interactions
Monitoring
Baseline Monitoring
Thyroid Stimulating Hormone (TSH)
Rationale: To confirm diagnosis of hypothyroidism and establish baseline.
Timing: Prior to initiation of therapy.
Free Thyroxine (Free T4)
Rationale: To assess thyroid function and differentiate primary from secondary hypothyroidism.
Timing: Prior to initiation of therapy.
Clinical symptoms of hypothyroidism
Rationale: To establish baseline symptom severity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Thyroid Stimulating Hormone (TSH)
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 condition).
Action Threshold: Adjust dose if TSH is outside target range.
Clinical symptoms of hypothyroidism/hyperthyroidism
Frequency: At each follow-up visit.
Target: Resolution of hypothyroid symptoms without development of hyperthyroid symptoms.
Action Threshold: Evaluate for dose adjustment or other causes if symptoms persist or new symptoms develop.
Symptom Monitoring
- Fatigue
- Weight gain
- Constipation
- Cold intolerance
- Dry skin
- Hair loss
- Bradycardia
- Depression
- Anxiety
- Palpitations
- Tremor
- Heat intolerance
- Weight loss
- Diarrhea
- Tachycardia
Special Patient Groups
Pregnancy
Levothyroxine is essential for normal fetal development. Thyroid hormone requirements often increase during pregnancy. Continue therapy and monitor TSH levels frequently (e.g., every 4 weeks during the first half of pregnancy) to ensure adequate dosing.
Trimester-Specific Risks:
First Trimester:
Inadequate maternal thyroid hormone can lead to impaired fetal neurological development.
Second Trimester:
Continued need for adequate maternal thyroid hormone.
Third Trimester:
Continued need for adequate maternal thyroid hormone.
Lactation
Levothyroxine is compatible with breastfeeding. Minimal amounts are excreted into breast milk, and it is not expected to cause adverse effects in breastfed infants.
Infant Risk:
Low risk.
Pediatric Use
Dosing is weight-based and crucial for normal growth and intellectual development. Regular monitoring of TSH and clinical status is essential. Tirosint-SOL may be particularly useful for infants and young children who cannot swallow tablets.
Geriatric Use
Older patients may require lower starting doses and smaller dose increments due to increased sensitivity to thyroid hormones and a higher prevalence of underlying cardiac disease. Monitor for cardiac symptoms.
Clinical Information
Clinical Pearls
- Tirosint-SOL is a liquid formulation that may be beneficial for patients with malabsorption issues (e.g., celiac disease, lactose intolerance, gastric bypass) or those who cannot swallow pills.
- Always take levothyroxine on an empty stomach, 30-60 minutes before breakfast, and separate from other medications and supplements by at least 4 hours.
- Consistency is key: take at the same time each day and avoid switching brands or formulations without medical advice.
- TSH levels are the primary guide for dose adjustments; Free T4 may also be monitored.
- Symptoms of over- or under-treatment can be subtle; educate patients on what to look for.
Alternative Therapies
- Levothyroxine sodium tablets (e.g., Synthroid, Levoxyl, Unithroid)
- Levothyroxine sodium capsules (e.g., Tirosint)
- Liothyronine (T3) (e.g., Cytomel)
- Liotrix (T4/T3 combination) (e.g., Thyrolar)
- Desiccated thyroid extract (e.g., Armour Thyroid, NP Thyroid)
Cost & Coverage
Average Cost:
Varies widely, typically higher than generic tablets per 30 ml bottle (137mcg/ml)
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand-name, Tier 1 for generic.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.